2015 Annual Report

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Sharing Knowledge.
Sharing Hope.
2015 Annual Report
CIBMTR® (Center for International Blood and Marrow Transplant Research®) is a research collaboration
between the National Marrow Donor Program®/Be The Match® and Medical College of Wisconsin
2015 Annual Report
January – December
Milwaukee Campus
Medical College of Wisconsin
9200 W Wisconsin Ave,
Suite C5500
Milwaukee, WI 53226
(414) 805-0700
Minneapolis Campus
National Marrow Donor Program/
Be The Match
500 N 5th St
Minneapolis, MN 55401
(612) 627-5800
cibmtr.org
CIBMTR 2015 Annual Report
TABLE OF CONTENTS
TABLE OF CONTENTS
1.0 WHO WE ARE ........................................................................................................................................ 1
1.1 Mission .............................................................................................................................................. 1
1.2 Value to the HCT Community ............................................................................................................ 1
1.3 Organizational Structure ................................................................................................................... 1
1.3.1 Scientific Working Committees .................................................................................................. 6
2.0 WHAT WE DO ........................................................................................................................................ 8
2.1 Clinical Outcomes Research Program ............................................................................................. 11
2.1.1 Scientific Working Committees ................................................................................................ 11
2.1.2 Cellular Therapies and Non-Transplant Therapy Research Initiatives ..................................... 15
2.2 Immunobiology Research Program ................................................................................................. 16
2.3 Clinical Trials Support Program ....................................................................................................... 18
2.3.1 Blood and Marrow Transplant Clinical Trials Network ............................................................ 18
2.3.2 Resource for Clinical Investigations in Blood and Marrow Transplantation ............................ 20
2.4 Health Services Research Program.................................................................................................. 21
2.5 Bioinformatics Research Program ................................................................................................... 23
2.6 Statistical Methodology Research Program .................................................................................... 24
2.7 Stem Cell Therapeutic Outcomes Database (SCTOD) ..................................................................... 25
2.8 Corporate Program.......................................................................................................................... 27
3.0 HOW WE SHARE KNOWLEDGE ........................................................................................................... 28
3.1 Information Request Service ........................................................................................................... 33
3.2 Internet Presence ............................................................................................................................ 34
3.2.1 CIBMTR Public Website ............................................................................................................ 34
3.2.2 CIBMTR Collaborative Site ........................................................................................................ 35
3.2.3 CIBMTR Portal Site.................................................................................................................... 36
3.2.4 Be The Match Public Website................................................................................................... 37
3.2.5 Be The Match Clinical Website ................................................................................................. 37
3.2.6 HRSA Blood Cell Transplant Website........................................................................................ 37
3.2.7 Other Applications and Data Exchange Standards................................................................... 38
3.3 BMT Tandem Meetings ................................................................................................................... 39
3.4 Data Management Training ............................................................................................................ 40
4.0 HOW WE COLLECT AND MANAGE DATA ............................................................................................ 41
4.1 Research Data Life Cycle ................................................................................................................. 41
4.2 Collecting and Storing Data ............................................................................................................. 42
4.2.1 FormsNet .................................................................................................................................. 42
4.2.2 Research Database ................................................................................................................... 42
4.3 Ensuring Data Quality ...................................................................................................................... 42
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CIBMTR 2015 Annual Report
TABLE OF CONTENTS
4.3.1 Continuous Process Improvement ........................................................................................... 42
4.3.2 Verification and Validation ....................................................................................................... 43
4.3.3 On-Site Data Audit Program ..................................................................................................... 44
4.4 Protecting Patients and Data .......................................................................................................... 45
4.4.1 Human Subjects / HIPAA Compliance ...................................................................................... 45
4.4.2 Information Security and Data Privacy..................................................................................... 45
5.0 WHAT WE WILL DO NEXT.................................................................................................................... 46
2015 KEY ACCOMPLISHMENTS ................................................................................................................. 49
APPENDIX A: TRANSPLANT CENTERS ........................................................................................................ 53
Appendix A1: US Centers....................................................................................................................... 54
Appendix A2: International Centers ...................................................................................................... 65
APPENDIX B: COORDINATING CENTER ORGANIZATIONAL STRUCTURE AND LEADERSHIP ..................... 74
Appendix B1: Organizational Structure – Milwaukee Campus ............................................................. 75
Appendix B2: Organizational Structure – Minneapolis Campus ........................................................... 76
Appendix B3: Coordinating Center Leadership ..................................................................................... 78
APPENDIX C: COMMITTEE MEMBERSHIP ................................................................................................. 87
Appendix C1: Advisory Committee Membership .................................................................................. 87
Appendix C2: Executive Committee Membership ................................................................................ 90
Appendix C3: Consumer Advocacy Committee Membership ............................................................... 92
Appendix C4: Nominating Committee Membership............................................................................. 93
Appendix C5: Scientific Working Committee Leadership ..................................................................... 94
Appendix C6: Immunobiology Steering Committee Membership ........................................................ 98
Appendix C7: Clinical Trials Advisory Committee Membership ............................................................ 99
APPENDIX D: PUBLICATIONS ................................................................................................................... 100
Appendix D1: Scientific Working Committee Publications ................................................................. 100
Appendix D2: BMT CTN Publications .................................................................................................. 112
Appendix D3: Health Services Research Program Publications .......................................................... 115
Appendix D4: Bioinformatics Research Program Publications ........................................................... 116
Appendix D5: Statistical Methodology Research Program Publications ............................................ 119
Appendix D6: Coordinating Center Publications................................................................................. 120
APPENDIX E: PRESENTATIONS ................................................................................................................ 124
APPENDIX F: STUDY DEVELOPMENT AND MANAGEMENT PROCESS ..................................................... 132
APPENDIX G: CLINICAL TRIALS ................................................................................................................ 135
Appendix G1: BMT CTN Clinical Trials Open for Enrollment ............................................................... 135
Appendix G2: RCI BMT Clinical Trials .................................................................................................. 137
APPENDIX H: FORMS SUBMISSION PROCESS ......................................................................................... 140
APPENDIX I: WEBSITES ............................................................................................................................ 141
APPENDIX J: GLOSSARY ........................................................................................................................... 142
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CIBMTR 2015 Annual Report
TABLE OF CONTENTS
FIGURES AND TABLES
Figure 1.1. Scientific Organizational Structure ........................................................................................... 2
Figure 1.2. Functional Organizational Structure with Scientific Oversight................................................. 3
Table 1.3. Committee Structure ................................................................................................................. 4
Figure and Table 2.1. Distribution of Patients in the CIBMTR Research Database by Graft Source .......... 8
Figure and Table 2.2. Distribution of Patients in the CIBMTR Research Database by Disease .................. 9
Figure 2.3. Continued Growth in the Number of Patients Registered with the CIBMTR ......................... 10
Table 2.4. 2015 Working Committee Studies ........................................................................................... 12
Figure 2.5. 2015 Publications by Program ................................................................................................ 13
Figure 2.6. Working Committee Study Proposal Review Process............................................................. 14
Figure 3.1. How to Access CIBMTR Knowledge ........................................................................................ 28
Table 3.2. How to Access CIBMTR Information ........................................................................................ 29
Table 3.3 How to Access CIBMTR Data ..................................................................................................... 29
Table 3.4 How to Access CIBMTR Tools .................................................................................................... 30
Table 3.5 How to Access CIBMTR Biospecimens ...................................................................................... 30
Table 3.6. Standard Reports Published by the CIBMTR ............................................................................ 31
Table 3.7. Data Requests Addressed by the CIBMTR in 2015................................................................... 33
Figure 4.1. Research Data Life Cycle ......................................................................................................... 41
Figure 4.2. Audit Process .......................................................................................................................... 44
Figure 5.1. Plans for 2016 ......................................................................................................................... 46
Table 5.2. Plans to Enhance Data.............................................................................................................. 47
Table 5.3. Plans to Expand Knowledge Sharing ........................................................................................ 47
Table 5.4. Plans to Increase Impact .......................................................................................................... 48
Figure A.1. Location of Transplant Centers that Submit Data to the CIBMTR ......................................... 53
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CIBMTR 2015 Annual Report
1.0 WHO WE ARE
1.0 WHO WE ARE
The CIBMTR® (Center for International Blood
and Marrow Transplant Research®) is a
research collaboration between the National
Marrow Donor Program® (NMDP)/Be The
Match® and the Medical College of Wisconsin
(MCW).
1.1 MISSION
The CIBMTR collaborates with the global
scientific community to advance hematopoietic
cell transplantation (HCT) and cellular therapy
worldwide to increase survival and enrich
quality of life for patients. The CIBMTR
facilitates critical observational and
interventional research through scientific and
statistical expertise, a large network of
transplant centers, and a unique and extensive
clinical outcomes database.
CIBMTR Programs
Clinical Outcomes Research
Immunobiology Research
Clinical Trials Support
• Blood and Marrow Transplant Clinical
Trials Network (BMT CTN)
• Resource for Clinical Investigations in
Blood and Marrow Transplantation
(RCI BMT)
Health Services Research
Bioinformatics Research
Statistical Methodology Research
1.2 VALUE TO THE HCT COMMUNITY
The CIBMTR has been collecting HCT outcomes
data worldwide for >40 years, resulting in a
Research Database with information on
>425,000 patients. These data are available to
investigators with interest in HCT and
treatments for cancer and other lifethreatening diseases. The CIBMTR has become
a respected leader in HCT research by providing
a unique resource of information and expertise
to the medical and scientific communities.
1.3 ORGANIZATIONAL STRUCTURE
The CIBMTR (Figures 1.1 and 1.2) represents a
large network of approximately 400
participating transplant centers (Appendix A)
that submit transplant-related data for
patients. Centers submit data at two levels: a
Transplant Essential Data (TED) level, which
captures basic data, and a Comprehensive
Report Form (CRF) level, which captures more
detail. The CIBMTR Coordinating Center, staffed
by almost 200 employees (Appendix B),
provides data acquisition, management, and
statistical support for analyses of these data.
The Chief Scientific Director is responsible for
all administrative and scientific operations. The
Associate and Senior Scientific Directors assist
in overseeing operational aspects of the
Coordinating Center. CIBMTR committees
(Table 1.3) provide input and advice to the
leadership team, ensuring the continued
support of both the needs and priorities of the
scientific and medical communities.
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CIBMTR 2015 Annual Report
1.0 WHO WE ARE
Figure 1.1. Scientific Organizational Structure
Transplant Centers
CIBMTR
Assembly
National Marrow Donor
Program/Be The Match
Medical College of
Wisconsin
Joint Affiliation Committee
Executive Director
J Chell, MD
Executive Committee
Advisory role
Advisory
Committee
Senior Scientific Director
for Research Operations
M Eapen, MBBS, MS
Chief Statistical
Director
MJ Zhang, PhD
Chief Scientific Director
M Horowitz, MD, MS
Senior Scientific Director
for SCTOD
JD Rizzo, MD, MS
Scientific Working Committees
Steering Committees
Statistical
Methodology
Research Program
MJ Zhang, PhD
Clinical Outcomes
Research Program
M Eapen, MBBS, MS
Associate Scientific
Director for CIBMTR
Minneapolis
D Confer, MD
Senior Research Advisor
D Weisdorf, MD
Advisory role
Health Services
Research Program
L Burns, MD
Consumer Advocacy
Committee
Immunobiology
Research Program
S Lee, MD, MPH
Senior Scientific Director
for Data Operations
B Shaw, MD, PhD
Clinical Trials
Support Program
D Confer, MD
L Burns, MD
M Pasquini, MD, MS
B Shaw, MD, PhD
Blood and Marrow Transplant
Clinical Trials Network
(BMT CTN)
M Pasquini, MD, MS
Bioinformatics
Research Program
M. Maiers, MS
Resource for Clinical Investigations
in Blood and Marrow Transplantation
(RCI BMT)
D Confer, MD
L Burns, MD
B Shaw, MD, PhD
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CIBMTR 2015 Annual Report
1.0 WHO WE ARE
Figure 1.2. Functional Organizational Structure with Scientific Oversight
Research & Administration
M Horowitz & D Confer
Faculty
CIBMTR Administration
Finance, Grants & Contracts
M Horowitz & D Confer
P Steinert & R King
MCW & NMDP/Be The Match
PhDs
MDs
Statistics &
Observational
Research
Human
Research
Protection
Program
W Perez &
S Spellman
MKE & MPLS
R King
MPLS
(M Eapen)
(**B Lindberg)
Immunobiology
Research
Statistics &
Clinical
Outcomes
S Spellman
MPLS
W Perez &
S Spellman
MKE & MPLS
(S Lee)
(MJ Zhang)
(M Eapen)
Health
Services
Research*
E Denzen
MPLS
(L Burns)
Clinical Studies
Support
Quality
Assurance
BMT CTN
Information
Technology
R Drexler
MPLS
TBD
MKE
A Foley
MPLS
E Bergman &
M Prestegaard
MKE & MPLS
(D Confer)
(L Burns)
(B Shaw)
(M Horowitz)
(M Pasquini)
RCI BMT
R Drexler
MPLS
(D Confer)
(L Burns)
(B Shaw)
Business Office
Advancement
Auditing &
Monitoring
Data Operations
Bioinfomatics
C Gonzalez &
P Vespalec
MKE
S Fisher &
T Houseman
MKE & MPLS
D Christianson
MPLS
J Brunner &
M Matlack
MKE & MPLS
M Maiers
MPLS
(M Horowitz)
(B Shaw)
(B Shaw)
(M Eapen)
(D Rizzo)
(B Shaw)
Survey
Research
Group
Project
Management
& Analysis
Applications
Data
Solutions
D Mattila
MPLS
T Moerke
& K Gee
MKE & MPLS
T Hongyu
& E Chan
MKE & MPLS
R Renner
MPLS
Corporate
Meetings
S Fisher
MKE
T Houseman
MPLS
(M Eapen)
(M Horowitz)
Data
Management
Special
Projects
Recipient
Data
Management
Donor Data
Management
J Brunner &
M Matlack
MKE & MPLS
S Meiers &
K Gardner
MKE &
MPLS
A Hauck
MPLS
(B Shaw)
(B Shaw)
(D Confer)
(D Confer)
Database
Administrator
& Data
Architect
B Liu &
TBD
MKE & MPLS
Technical
Services
T Moerke
MKE
Communications
S Fisher
MKE
(M Horowitz)
Data Entry
& Imaging
Data
Support
Training
B Levesque
MPLS
M Matlack
MPLS
M Matlack
MPLS
(B Shaw)
(B Shaw)
(B Shaw)
Key: MKE = Milwaukee, MPS = Minneapolis, ( ) indicates scientific oversight, *staffed through NMDP/Be The Match Patient and Health Professional Services, ** institutional official oversight
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CIBMTR 2015 Annual Report
1.0 WHO WE ARE
Table 1.3. Committee Structure
Committee
Function
Joint Affiliation Board
• Reviews and approves the CIBMTR budget and research plan
• Amends the terms of the affiliation agreement, as necessary
• Reviews and approves data access and confidentiality policies
• Annually
Assembly
• Includes representatives from each transplant center that
submits CRF-level data
• Elects members of the Advisory, Nominating, and Clinical Trials
Advisory Committees
• Annually during the BMT
Tandem Meetings
Advisory Committee
• Oversees CIBMTR policies and scientific agenda
• Partners with the Working Committees to prioritize scientific
studies
Executive Committee
• Provides scientific and policy advice to the Chief Scientific
Director and Coordinating Center
• Reviews audit results and makes recommendations for
improvement
Consumer Advocacy
Committee
• Provides patient and donor perspectives during the
development of the CIBMTR research agenda
• Communicates CIBMTR research results and data to the nonmedical community
Nominating
Committee
• Prepares a slate of candidates for open positions on the
Advisory, Nominating, and Clinical Trials Advisory Committees
• Makes recommendations to the Advisory Committee for open
Working Committee Chair and other leadership appointments
(subcommittee of
Advisory Committee)
(subcommittee of
Advisory Committee)
Meetings
Roster
• In person annually at the
BMT Tandem Meetings
• By teleconference
quarterly and as needed
Appendix C1
• Four times annually by
teleconference
Appendix C2
• In person annually at the
BMT Tandem Meetings
• By teleconference
periodically
Appendix C3
• At least once annually each Appendix C4
Fall by teleconference
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CIBMTR 2015 Annual Report
1.0 WHO WE ARE
Committee
Function
Meetings
Roster
Scientific Working
Committees
(Section 1.3.1)
• Design and conduct relevant studies using CIBMTR data,
statistical resources, networks, and / or centers
• Set priorities for clinical outcomes studies
• Assess and revise CIBMTR data collection forms, as needed
• Plan and conduct workshops at CIBMTR meetings
• In person annually at the
BMT Tandem Meetings
• Leadership - by
teleconference every 4-8
weeks
Immunobiology
Steering Committee /
NMDP/Be The Match
Histocompatibility
Advisory Group
• Reviews and approves the use of donor-recipient specimens
from the Research Repository in CIBMTR studies
• In person twice annually, in Appendix C6
summer and at the BMT
Tandem Meetings
Clinical Trials Advisory
Committee
• Assists in the review, approval, and oversight of proposals and
protocols for Phase I and Phase II clinical trials submitted to the
RCI BMT
• In person annually at the
BMT Tandem Meetings
• By teleconference as
needed
Leadership Appendix C5
Appendix C7
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CIBMTR 2015 Annual Report
1.0 WHO WE ARE
To ensure broad input into the research
process and efficient use of resources, the
CIBMTR facilitates 15 Scientific Working
Committees focused on specific research areas.
pharmacogenetics, stem cell biology, and other
areas related to HCT provide essential expertise
in their respective research areas. The Working
Committee structure encourages a
collaborative but rigorous methodological
approach to all CIBMTR activities.
Scientific Working Committees
Working Committee Leadership
1.3.1 Scientific Working Committees
Acute Leukemia
Chairs (usually 3-4)
Autoimmune Diseases and Cellular Therapies
MD Scientific Director
Chronic Leukemia
PhD Statistical Director
Donor Health and Safety
MS-level Statistician
Graft Sources and Manipulation
Graft-versus-Host Disease
Health Services and International Studies
Immunobiology
Infection and Immune Reconstitution
Late Effects and Quality of Life
Lymphoma
Pediatric Cancer
Plasma Cell Disorders and Adult Solid Tumors
Primary Immune Deficiencies, Inborn Errors
of Metabolism, and Other Non-Malignant
Marrow Disorders
Regimen-Related Toxicity and Supportive
Care
Total Working Committee membership exceeds
2,300 researchers. Membership is open to any
researcher willing to take an active role in
developing and conducting studies that use
CIBMTR data and / or resources. While most of
these individuals are HCT clinicians, statisticians
and basic scientists also participate. PhD-level
statistical faculty and Master’s-level
statisticians from the CIBMTR Coordinating
Center provide their unique expertise in data
analysis. Basic scientists investigating human
leukocyte antigen (HLA), immunogenetics,
Working Committee leadership is listed in
Appendix C5.
1.3.1.1 Working Committee Chairs
Working Committee Chairs are appointed by
the Advisory Committee to non-renewable fiveyear terms. Appointments are made each fall,
with terms commencing on March 1 of the
following year. Terms are staggered to facilitate
succession and maintain continuity. Individuals
may serve as Chair more than once but not
consecutively for the same committee. The
Nominating Committee polls the CIBMTR
membership for potential Chair candidates for
open Chair positions. Current Chairs participate
in the nomination process for replacement
positions and give special consideration to
promising junior investigators, thus promoting
ongoing leadership for the work of the CIBMTR.
Working Committee Chairs provide subject
matter expertise in autologous and allogeneic
transplantation as well as understanding of
CIBMTR organization and procedures. They
must be members of CIBMTR centers that
submit CRFs and that are compliant with
Continuous Process Improvement (CPI)
standards for data submission, unless an
exception is granted by the Advisory
Committee. Chairs are occasionally selected
from outside these guidelines for their specific
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CIBMTR 2015 Annual Report
1.0 WHO WE ARE
scientific expertise, for example, a scientist who
directs a histocompatibility laboratory,
apheresis center, or donor registry, who is
committed to the CIBMTR and to the field of
HCT.
Chairs monitor and facilitate the progress of
studies in their Working Committee’s portfolio.
They communicate with Principal Investigators
to address barriers and / or delays in study
completion and participate in weekly CIBMTR
Coordinating Center study critiques when
studies in their portfolios are being discussed.
In addition to chairing annual Working
Committee meetings, Chairs meet by
teleconference every four to six weeks with
their committee’s Scientific Director and
biostatisticians to review the progress of study
proposals and ongoing studies. Chairs lead the
annual Working Committee meeting and, using
input from that meeting, prioritize studies and
set the research agenda for the following year.
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CIBMTR 2015 Annual Report
2.0 WHAT WE DO
2.0 WHAT WE DO
The CIBMTR collects data for approximately
21,000 new transplant patients annually as
well as a continually increasing volume of
follow-up data on previously reported
recipients and donors. Submission of
outcomes data is mandatory for allogeneic
transplants in the US and those outside the US
that use a US donor; all other submissions are
voluntary. The CIBMTR estimates that almost
100% of US allogeneic transplants and about
80% of US autologous transplants are
reported.
The CIBMTR Research Database contains
information on >425,000 patients. The
distribution of patients in the database is
displayed by graft type in Figure and Table 2.1
and by disease in Figure and Table 2.2.Figure
2.3 shows the continued growth in the number
of patients registered with the CIBMTR.
Publications
There were 76 CIBMTR publications in 2015.
As of December 31, an additional 17
manuscripts were submitted and are under
review. A complete list of publications is
provided in Appendix D.
Presentations
In 2015, CIBMTR study investigators presented
65 abstracts (41 oral and 24 poster) at
national and international conferences, a 50%
increase from last year. Presentations included
25 (17 oral and 8 poster) at the American
Society for Hematology (ASH) Annual Meeting
and 17 (13 oral and 4 poster) at the BMT
Tandem Meetings. A complete list of
presentations is provided in Appendix E.
Figure and Table 2.1. Distribution of Patients in the CIBMTR Research Database by
Graft Source
Graft Source
Bone Marrow
Peripheral Blood
Cord Blood
TOTAL
Allogeneic
Autologous
TED
CRF
TED
CRF
49,509 58,935
9,885
5,887
73,780 33,848 148,822 34,858
5,408
8,721
136
8
128,697 101,504 158,843 40,753
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CIBMTR 2015 Annual Report
2.0 WHAT WE DO
Figure and Table 2.2. Distribution of Patients in the CIBMTR Research Database by
Disease
Disease
Acute myelogenous leukemia
Acute lymphoblastic leukemia
Chronic myelogenous leukemia
MDS / myeloproliferative syndromes
Lymphoma
Plasma cell disorders
Other malignant diseases1
Severe aplastic anemia
Inherited erythrocyte disorders2
Immune deficiency disorders
TOTAL
Allogeneic
Autologous
TED
CRF
TED
CRF
40,448 28,231
5,721
2,379
21,096 16,616
1,089
469
13,914 15,163
414
282
12,805 10,635
182
86
15,793
8,009
64,110 13,514
4,141
2,169
57,615 11,594
6,039
3,794
28,917 12,247
5,981
6,753
14
8
6,085
7,133
781
174
2,395
3,001
0
0
128,697 101,504 158,843 40,753
1. Includes other leukemia (allogeneic, n=8,279; autologous, n=910), solid tumors
(allogeneic, n=1,554; autologous, n=40,254)
2. Includes inherited erythrocyte disorders (allogeneic, n=8,602; autologous, n=9),
inherited platelet disorder (allogeneic, n=186; autologous, n=4), inborn errors of
metabolism (allogeneic, n=2,499; autologous, n=0), histiocytic disorders
(allogeneic, n=1,413; autologous, n=16), autoimmune disease (allogeneic, n=125;
autologous, n=555), other disorders (allogeneic, n=393; autologous, n=371)
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CIBMTR 2015 Annual Report
2.0 WHAT WE DO
Figure 2.3. Continued Growth in the Number of Patients Registered with the CIBMTR
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CIBMTR 2015 Annual Report
2.0 WHAT WE DO
2.1 CLINICAL OUTCOMES RESEARCH PROGRAM
Clinical outcomes research using the CIBMTR
Research Database is a core activity of the
organization. These studies address a wide
range of issues, focusing on questions that are
difficult or impossible to address in singlecenter studies or randomized trials because
diseases treated with HCT are uncommon,
single centers treat few patients with a given
disorder, and not all important questions are
amenable to a randomized research design.
2.1.1 Scientific Working Committees
Program Activities
The 15 Scientific Working Committees oversee
most of the CIBMTR’s clinical outcomes
research. There are currently 176 studies in
progress (Table 2.4). These studies and those
recently published are detailed in the 2015
Report on Working Committee Studies. For the
2015 BMT Tandem Meetings, the Working
Committees reviewed 157 new study
proposals, 73 of which were presented and 35
of which were approved. The prioritization and
selection process ensures that the most
important issues can be addressed in a timely
manner.
Publications
In 2015, Working Committee study
investigators published 38 manuscripts in
peer-reviewed journals, about 50% of the
total number of CIBMTR publications this year
(Figure 2.5). As of December 31, an additional
15 manuscripts were submitted for
publication and are under review. A complete
list of Working Committee publications is
provided in Appendix D1.
Key Working Committee
Publications this Year
Chen Y-B et al. Impact of conditioning
regimen on outcomes for patients with
lymphoma undergoing high-dose therapy
with autologous HCT. Biology of Blood and
Marrow Transplantation. 2015 Jun 1;
21(6):1046-1053. Epub 2015 Feb 13.
PMC4426014.
Sorror ML et al. Prospective validation of
the predictive power of the HCT
comorbidity index: a CIBMTR® study.
Biology of Blood and Marrow
Transplantation. 2015 Aug 1; 21(8):14791487. Epub 2015 Apr 7. PMC4512746.
Orchard PJ et al. HCT for infantile
osteopetrosis. Blood. 2015 Jul 9;
126(2):270-276. Epub 2015 May 26.
PMC4497967.
Ciurea SO et al. Haploidentical transplant
with post-transplant cyclophosphamide vs
matched unrelated donor transplant for
acute myeloid leukemia. Blood. Epub 2015
Jun 30.
Kollman C et al. The effect of donor
characteristics on survival after unrelated
donor transplantation for hematologic
malignancy. Blood. Epub 2015 Nov 2.
Presentations
In 2015, Working Committee study
investigators presented 38 abstracts (26 oral
and 12 poster), including 19 (11 oral and 8
poster) at the ASH Annual Meeting and 10 (9
oral and 1 poster) at the BMT Tandem
Meetings. A complete list of CIBMTR
presentations is provided in Appendix E.
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CIBMTR 2015 Annual Report
2.0 WHAT WE DO
Table 2.4. 2015 Working Committee Studies
Working Committee
Studies in
Progress
Publications Presentations
Acute Leukemia
13
3
4
Autoimmune Diseases and Cellular Therapies
6
0
0
Chronic Leukemia
12
0
3
Donor Health and Safety
11
2
6
Graft Sources and Manipulation
5
3
0
Graft-versus-Host Disease
10
2
2
Health Services and International Studies
12
2
4
Immunobiology
43
6
5
Infection and Immune Reconstitution
9
1
0
Late Effects and Quality of Life
11
2
2
Lymphoma
6
6
7
Pediatric Cancer
4
2
0
Plasma Cell Disorders and Adult Solid Tumors
12
2
2
Primary Immune Deficiencies, Inborn Errors of
Metabolism, and Other Non-Malignant Marrow
Disorders
10
3
0
Regimen-Related Toxicity and Supportive Care
12
6
3
TOTAL
176
38*
38
*Two studies are joint studies between two committees.
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CIBMTR 2015 Annual Report
2.0 WHAT WE DO
Funding
Successful Working Committee
Study Proposals are
Support for the Working Committees is
primarily provided by the National Institutes of
Health (NIH) grant # U24CA076518 from the
National Cancer Institute (NCI); National Heart,
Lung, and Blood Institute (NHLBI); and National
Institute for Allergy and Infectious Disease
(NIAID).
Feasible. Utilize data available in the
CIBMTR Research Database.
Unique. Fill a gap not addressed by
current studies or publications.
How to Get Involved
Important. Impact the field by improving
Working Committees are collaborative in
nature, and all interested individuals are
encouraged to participate. Please feel free to
attend annual in-person meetings of the
Working Committees at the BMT Tandem
Meetings in February. Additionally, anyone
willing to follow the study development and
management process (Appendix F) is eligible
to propose a study to the Working Committees
(Figure 2.6).
transplant procedures or results.
See the CIBMTR How to Propose a Study
webpage for additional guidelines and
advice as well as the Study Proposal
Outline.
Figure 2.5. 2015 Publications by Program
Coordinating
Center
(14)
Bioinformatics
(9)
Clinical
Outcomes Working
Committees
(38)
BMT CTN
(8)
Other
(9)
Statistical
Methodology
(5)
Health
Services (4)
Page | 13
CIBMTR 2015 Annual Report
2.0 WHAT WE DO
Figure 2.6. Working Committee Study Proposal Review Process
Submission
Initial
Review
• By November 15, study investigator submits proposal to the CIBMTR Coordinating
Center for consideration at the next BMT Tandem Meetings.
• Working Committee Leaderships reviews for feasibility with CIBMTR data,
potential conflict with active studies, scientific merit, and ability to complete the
study in a timely fashion. Researchers with similar concepts may be advised to
combine their proposals.
• If Working Committee Leadership clears the proposal to move forward, the MSlevel Statistician contacts the study investigator and prepares a table of
Preliminary
characteristics of patient data based on the population defined in the proposal.
Assessment
Presentation
Voting
Final
Approval
Notification
• Study investigator presents the proposal at the Working Committee meeting at
the February BMT Tandem meetings.
• Working Committee members vote for each proposal, assigning a scientific impact
score to each.
• Working Committee Leadership utilizes member feedback in determining which
proposals to pursue. Advisory Committee approves the CIBMTR research agenda.
• Working Committee Leadership contacts study investigator to notify of study
approval / rejection by the end of April.
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CIBMTR 2015 Annual Report
2.1.2 Cellular Therapies and Non-Transplant
Therapy Research Initiatives
With the consensus and support of its Advisory
Committee, the CIBMTR is committed to
collecting data on cellular therapies and nontransplanted patient populations. The CIBMTR
amended its registration of cases to
accommodate data collection for cellular and
other therapies that may not involve
transplantation. Additionally, the CIBMTR is
working collaboratively with the Primary
Immune Deficiency Disease Consortium to add
transplant outcomes data to data on nontransplant therapy collected by the
Consortium.
Cellular Therapies
In 2015, the CIBMTR initiated a Cellular
Therapies Task Force charged with
determining appropriate content and structure
for cellular therapies data collection. The
CIBMTR also hosted a Cellular Therapies Forum
in October 2015 to discuss how to further
develop and provide recommendations for a
cellular therapy registry. Participants included
physicians, scientists, manufacturers, and
government representatives.
Cellular Therapies Forum
Discussion Topics
Cell therapy for treatment of viral
infection
CAR-T cells for malignancies
Manufacturing models
Regulatory framework and long-term
outcomes reporting
NCI Cancer Immunotherapy Trials
Network
2.0 WHAT WE DO
Myelodysplastic Syndrome
The CIBMTR collects data on patients receiving
non-HCT therapy for myelodysplastic
syndrome (MDS) to compare with an ongoing
study of HCT outcomes. By combining its
resources with those of the BMT CTN (Section
2.3.1), the CIBMTR is able to do this in a costeffective manner. Through November 2015,
34 centers have been activated and 141
patients enrolled on this non-HCT therapy
study.
The HCT outcomes study was launched in 2010
because many elderly patients with MDS were
denied access to HCT therapy in the US due to
lack of Medicare insurance coverage by the
Centers for Medicare and Medicaid Services
(CMS). To help secure Medicare coverage for
these patients, the CIBMTR, NMDP/Be The
Match, American Society for Blood and
Marrow Transplantation (ASBMT), and other
organizations partnered with CMS to develop a
Coverage with Evidence Development (CED)
study, using data in the CIBMTR Research
Database that are collected to fulfill SCTOD
requirements. The CED approach allows CMS
to provide coverage for procedures and to
advocate for clinical studies that inform policy
decisions. The CMS-approved study now has
>2,300 patients enrolled.
Assessment of HCT in Medicare
Beneficiaries with MDS
127 centers
1,294 patients ≥65 years old
815 patients 55-64 years old
213 patients <54 years old
Proposed CIBMTR Cellular Therapy
Registry
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CIBMTR 2015 Annual Report
2.0 WHAT WE DO
2.2 IMMUNOBIOLOGY RESEARCH PROGRAM
The CIBMTR maintains a Research Repository
of paired tissue samples from donors and
recipients, both unrelated and related. The
Immunobiology Research group manages the
Research Repository inventory and
immunogenetic testing programs that add
critical HLA and killer-cell immunoglobulin-like
receptors (KIR) data for use in CIBMTR clinical
outcomes studies.
The CIBMTR leverages the NMDP/Be The
Match’s investment in the Unrelated Donor
Research Repository with the NIH’s investment
in the CIBMTR Research Database. Linking
outcomes data to immunologic data available
in the Research Repository supports studies
that include genetic and immunobiologic data
and clinical phenotype data.
The Related Donor Research Repository,
supported by the Health Resources and
Services Administration (HRSA), is a unique
opportunity to enhance immunobiologic
research. Related donor and recipient samples
are better matched than unrelated recipients
for HLA, a measure of immunological
compatibility, thus reducing the confounding
effects of HLA disparity in clinical research.
The combination of the Unrelated Donor and
Related Donor Research Repositories
facilitates an organized approach to studying
transplant biology across the full spectrum of
allogeneic HCT.
Program Activities
In 2015, 175 centers (128 transplant centers,
32 donor centers, and 15 cord blood banks)
provided samples to the Research Repository.
The Immunobiology Research group enhanced
the Research Repository inventory and
Immunogenetic Database this year by
completing high resolution HLA and presence /
absence KIR typing on 226 related and 2,772
unrelated HCT donor / cord and recipient
Research Repository
2,043,345 aliquots
18,901 cell lines
59,375 samples from unrelated donors
and 5,128 from related donors
57,018 samples from unrelated recipients
and 5,377 from related recipients
10,566 samples from unrelated cord blood
units
Samples from complete pairs:
33,919 from complete unrelated adult
donor-recipient pairs
4,545 from complete related donorrecipient pairs
3,579 from unrelated cord-recipient
pairs
pairs, bringing the total to >17,500 unrelated
donor / cord and recipient pairs that have
been retrospectively high resolution typed for
HLA-A, -B, -C, -DRB1 and -DQB1; >70% include
-DPB1, and >10,000 include KIR.
The Immunobiology Research group
consolidated all collections (unrelated, related,
and clinical trial) under one inventory
management system in 2015 and incorporated
their information into the Integrated Data
Warehouse to facilitate linkage of samples to
clinical data. Additionally, the group
distributed 8,770 research samples in support
of Working Committee studies this year.
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CIBMTR 2015 Annual Report
Publications
In 2015, Immunobiology Working Committee
study investigators published 6 manuscripts,
4 of which utilized research samples and
immunobiology clinical outcomes data. The
Immunobiology Research group also supports
other investigators’ publications by providing
research samples. 9 manuscripts published
this year by investigators from other Working
Committees and the BMT CTN utilized samples
from the Research Repository. A complete list
of Working Committee publications is provided
in Appendix D1.
Presentations
In 2015, 5 Immunobiology Working Committee
study investigators presented at national and
international conferences, including 2 oral
abstracts at the European Group for Blood and
Marrow Transplantation (EBMT) Annual
Meeting and 2 posters at the ASH Annual
Meeting. A complete list of CIBMTR
presentations is provided in Appendix E.
Funding
Support for the Immunobiology Research
Program is primarily provided by the Office of
Naval Research grant # N00014-14-1-0848, NIH
grant # U24CA076518, and HRSA contract #
HHSH250201200016C.
The Immunobiology Research Program offers
limited research funds supporting
immunobiology research studies. The grants
are intended to subsidize lab tests, sample
collection, or costs associated with the use of
research samples. These grants are available to
approved CIBMTR studies that support
organizational research priorities. For
additional information, visit the CIBMTR
Grants for Immunobiology Research webpage.
2.0 WHAT WE DO
Key Immunobiology
Publications this Year
Gadalla SM et al. Association between
donor leukocyte telomere length and
survival after unrelated allogeneic HCT for
severe aplastic anemia. Journal of the
American Medical Association. 2015 Feb 10;
313(6):594-602. PMC4388056.
Verneris MR et al. HLA mismatch is
associated with worse outcomes after
unrelated donor reduced-intensity
conditioning HCT: an analysis from the
CIBMTR. Biology of Blood and Marrow
Transplantation. 2015 Oct 1; 21(10):17831789. Epub 2015 Jun 6. PMC4568127.
Petersdorf EW et al. High HLA-DP
expression and graft-versus-host disease.
New England Journal of Medicine. 2015 Aug
13; 373(7):599-609. PMC4560117.
How to Get Involved
All interested parties may attend the annual
in-person meeting of the Immunobiology
Working Committee at the BMT Tandem
Meetings in February. Additionally, the
Immunobiology Working Committee
encourages highly translational, hypothesisdriven proposals through the Working
Committee Study Proposal Review Process
(Figure 2.6).
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CIBMTR 2015 Annual Report
2.0 WHAT WE DO
2.3 CLINICAL TRIALS SUPPORT PROGRAM
Using data from observational studies to
support decisions regarding design of
prospective clinical trials and / or amendments
of such trials, the CIBMTR Research Database
provides an important resource to the Clinical
Trials Support Program. This program consists
of the BMT CTN and RCI BMT, which conduct
multicenter clinical trials. Data from the
Research Database are used to design,
monitor, and analyze these trials.
CIBMTR Coordinating Center
Support of Clinical Trials
Trial Planning. Determine patient
populations available for trials as well as
appropriate inclusion criteria and outcome
estimates, and identify transplant centers
likely to accrue.
Data Collection. Share data to reduce
reporting for transplant centers, and share
data collection forms and database
structures developed by transplant experts.
Statistical Consultation. Provide expert
statistical review of protocols.
Real-Time Accrual Assessment.
Review data to evaluate center and patient
characteristics of enrolled and non-enrolled
patients to address accrual barriers.
Trial Interpretation. Evaluate results of
clinical trials, including through the
provision of matched controls.
Long-Term Follow-Up Data. Capture
follow-up data for long-term or secondary
analyses, resulting in considerable costsavings.
2.3.1 Blood and Marrow Transplant Clinical
Trials Network
The BMT CTN, sponsored by NHLBI and NCI, is
the US national trials group charged with
developing and conducting multicenter Phase
II and III clinical trials focused on HCT. The
CIBMTR is the lead institution for the BMT CTN
Data and Coordinating Center, which it runs in
collaboration with NMDP/Be The Match and
the Emmes Corporation, a contract research
organization based in Rockville, MD.
Program Activities
The BMT CTN has launched 37 trials (3 this
year), and completed accrual for 28 of these
trials (2 this year). The Network has accrued
>8,500 patients to its trials from >100
centers, including >1,100 this year. Among
trials currently open for enrollment, the BMT
CTN achieved an overall accrual rate in 2015
that is approximately 125% of projections.
The Network has established a Research
Sample Repository that currently includes
>350,000 biospecimens. Additionally, the
BMT CTN has conducted 48 ancillary and
correlative studies.
More detail regarding Network activities and
protocols is provided in the annual progress
report on the BMT CTN website. A list of
Network trials open for enrollment is provided
in Appendix G1.
Publications
In 2015, BMT CTN study investigators
published 8 manuscripts, 2 of which were
primary results papers. These bring the total
number of Network publications to 57,
including 16 primary results papers. A
complete list of 2015 BMT CTN publications is
provided in Appendix D2.
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CIBMTR 2015 Annual Report
Key BMT CTN Publications this Year
MacMillan ML et al. A refined risk score for
acute graft-versus-host disease that
predicts response to initial therapy,
survival, and transplant-related mortality.
Biology of Blood and Marrow
Transplantation. 2015 Apr 1; 21(4):761-767.
Epub 2015 Jan 10. PMC4359643.
Khera N et al. Comparison of characteristics
and outcomes of trial participants and
nonparticipants: example of BMT CTN
0201 trial. Biology of Blood and Marrow
Transplantation. 2015 Oct 1; 21(10):18151822. Epub 2015 Jun 11. PMC4568172.
Anderlini P et al. Cyclophosphamide
conditioning in patients with severe
aplastic anaemia given unrelated marrow
transplantation: a phase 1-2 dose deescalation study. Lancet Haematology.
2015 Sep 1; 2(9):367-375. Epub 2015 Sep 8.
Devine SM et al. Phase II study of
allogeneic transplantation for older
patients with acute myeloid leukemia in
first complete remission using a reducedintensity conditioning regimen: results
from CALGB 100103 / BMT CTN 0502.
Journal of Clinical Oncology. Epub 2015 Nov
2.
2.0 WHAT WE DO
Presentations
BMT CTN study investigators presented 11
abstracts (8 oral and 3 poster) at national and
international conferences in 2015, two of
which were highlighted at the ASH Annual
Meeting, one as a Late Breaking Abstract and
the other as a 2016 Highlight of ASH. These
bring the total number of Network
presentations to 59. A complete list of 2015
CIBMTR presentations is provided in Appendix
E.
Funding
Support for the BMT CTN Data and
Coordinating Center is provided by the NIH
grant # U10HL069294 from the NHLBI and NCI.
How to Get Involved
The Network is committed to widespread
participation in its trials. If you would like to
serve as an Affiliate Center, visit the BMT CTN
website for more information. Additionally,
you may act as a Center Principal Investigator
or champion a trial to increase patient accrual
at your Center, serve on a Protocol Team or an
Endpoint Review Committee, or act as a
Medical Monitor. You may also propose an
ancillary study, which uses data, biospecimens,
and / or analyses outside the specific
objectives of a primary BMT CTN study.
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CIBMTR 2015 Annual Report
2.0 WHAT WE DO
2.3.2 Resource for Clinical Investigations in Blood and Marrow Transplantation
The RCI BMT provides researchers in the field
of HCT with infrastructure and expertise in HCT
clinical trial conduct and analysis. The
program’s goal is to help investigators
generate data allowing novel and innovative
ideas to move into the larger Phase II or Phase
III setting with groups such as the BMT CTN or
the national cancer cooperative groups.
Program Activities
The RCI BMT has launched 15 trials, including
3 this year. In 2015, the RCI BMT accrued just
under 3,000 patients, bringing the total
number of accrued patients to approximately
28,000, of which >21,000 were enrolled in a
cohort study examining long-term outcomes of
unrelated donors.
The RCI BMT is currently managing 2 Food and
Drug Administration (FDA) investigational new
drug (IND) protocols for NMDP/Be The Match
Operations. Peripheral Blood Stem Cell (PBSC)
Procurement accrued >2,100 patients this
year, and Cord Blood Access accrued >500.
Additionally, the RCI BMT supported 5 studies
involving unrelated donor data or sample
collection for investigators.
In 2015, the RCI BMT launched two new
interconnected software systems to enhance
data collection and study management. These
systems will increase efficiency, allowing the
RCI BMT to effectively support a wide array of
clinical trials and research studies.
A complete list of RCI BMT trials is provided in
Appendix G2.
Presentations
In 2015, RCI BMT study investigators
presented 4 oral abstracts at national and
international conferences. A complete list of
CIBMTR presentations is provided in Appendix
E.
Survey Research Group
The Survey Research Group is a team within
the RCI BMT created to assist HCT researchers
in developing and conducting research
involving questionnaires, direct subject
interviews, and patient reported outcomes.
The group is responsible for collecting high
quality, scientifically valid data from donors,
patients, and their families. The Survey
Research Group utilizes standardized and
semi-structured telephone interviews as well
as self-administered questionnaires. In 2015,
the Survey Research Group supported 8 active
studies and participated in the development of
1 upcoming study.
Funding
Support for the RCI BMT is primarily provided
by the NIH grant # U24CA076518 from the NCI,
NHLBI, and NIAID; NMDP/Be The Match; and
corporate and private sponsors of specific
studies.
The RCI BMT team can work with study
investigators to seek funding from a variety of
sources, including government agencies,
foundations, pharmaceutical companies, and
private corporations.
How to Get Involved
Study investigators may solicit clinical trials
services from the RCI BMT, including
assistance with funding proposals; protocol
development and approvals; management of
study conduct; data auditing, management,
and analysis; and financial administration.
Study investigators may also contract for
specific services as needed, such as support
with surveys, site selection and management,
sample management, and more. For additional
information, visit the RCI BMT webpage.
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CIBMTR 2015 Annual Report
2.0 WHAT WE DO
2.4 HEALTH SERVICES RESEARCH PROGRAM
Health services research is the multidisciplinary field of scientific investigation that
studies how social factors, financial systems,
organizational structures and processes,
technology, and behavior affect treatment
outcomes, quality, and cost. The CIBMTR
conducts research through the Health Services
Research Program in collaboration with
NMDP/Be The Match’s Patient and Health
Professional Services. Research activities
complement those of the CIBMTR’s Health
Services and International Studies Working
Committee.
Health Services Focus Areas
Research
Health Policy
System Capacity Initiative
Program Evaluation
Clinical Trial Support
Training, Education, and Consultation
Program Activities
Research. The Health Services Research
Program currently has 9 studies in progress. In
2015, the program completed analysis for 3
research studies.
Health Policy. In collaboration with NMDP/Be
The Match’s Payer Policy department, the
Health Services Research Program conducted a
study, Financial barriers to HCT: the transplant
center perspective, to examine the impact of
the Patient Protection and Affordable Care Act
on access to HCT and treatment decisionmaking.
Select Health Services Research
Studies in Progress
Individualized care plans for HCT
survivors
Cost-effectiveness of HCT vs. alternative
therapy for acute myeloid leukemia
(AML) in patients aged 60-70 years
Analysis of reimbursement for HCT in
older patients
HCT multidisciplinary care teams:
burnout, moral distress, and career
satisfaction
Payer-partnered approach to
community-based referral for HCT
Easy-to-read informed consent forms for
HCT clinical trials (BMT CTN 1205)
System Capacity Initiative. The goal of the
System Capacity Initiative is to determine how
the US healthcare system can accommodate
the growing number of patients in need of
HCT. In 2015, the Health Services Research
Program continued to support initiativerelated efforts, including the study on HCT
workforce burnout.
Program Evaluation. The Health Services
Research Program conducted >30 evaluations
for the HRSA Office of Patient Advocacy /
Single Point of Contact contract and NMDP/Be
The Match programs in 2015, including a
needs assessment for limited English
proficiency patients.
Page | 21
CIBMTR 2015 Annual Report
Clinical Trial Support. A collaboration between
the Health Services Research Program and
BMT CTN, Easy-to-read informed consent
forms for HCT clinical trials evaluates the
effectiveness of a novel consent form and
describes barriers to implementation. The
program also provided technical writing
support and developed 3 easy-to-read consent
/ assent forms and 6 patient information
sheets for BMT CTN protocols.
Training, Education, and Consultation. In
2015, the Health Services Research Program
established the HCT Health Economics Interest
Group, which held its first meeting at the 2015
BMT Tandem Meetings.
More detail regarding program activities is
provided in the Health Services Research
Annual Report.
Publications
In 2015, Health Services Research study
investigators published 4 manuscripts in peerreviewed journals. A complete list of program
publications is provided in Appendix D3.
Presentations
Through the HRSA Office of Patient Advocacy /
Single Point of Contact contract, the Health
Services Research Program is charged with
disseminating findings to all stakeholder
groups. In 2015, program investigators
presented 3 oral abstracts at the ASH Annual
Meeting. A complete list of research-focused
CIBMTR presentations is provided in Appendix
E.
How to Get Involved
For more information about the Health
Services Research Program and / or the HCT
Health Economics Interest Group, contact Ellen
Denzen, MS, Senior Manager, at
edenzen@nmdp.org or 612.884.8562.
2.0 WHAT WE DO
Health Services Research
Publications this Year
Besse KL et al. Estimating demand and
unmet need for allogeneic HCT in the US
using geographic information systems.
Journal of Oncology Practice. 11(2):e120e130. Epub 2015 Mar 1. PMC4371120.
Majhail NS et al. National survey of HCT
center personnel, infrastructure and
models of care delivery. Biology of Blood
and Marrow Transplantation. 2015 Jul 1;
21(7):1308-1314. Epub 2015 Mar 31.
PMC4466059.
Clauser SB et al. Patient centeredness and
engagement in quality-of-care oncology
research. Journal of Oncology Practice.
2015 May 1; 11(3):176-179. Epub 2015 Apr
7.
Preussler JM et al. Patient housing barriers
to HCT: results from a mixed-methods
study of transplant center social workers.
Supportive Care in Cancer. Epub 2015 Aug
15.
Funding
Support for the Health Services Research
Program is provided by the NIH grant #
U24CA076518 from the NCI, NHLBI, and NIAID.
Individual studies are funded via a variety of
mechanisms. Individualized care plans for HCT
survivors is supported by the Patient Centered
Outcomes Research Institute award # CD-1212-4062; Easy-to-read informed consent forms
for HCT clinical trials is supported by the NHLBI
grant # U10HL069294-12S1, and A payerpartnered approach to community-based
referral for HCT is supported by the grant #
11762021 from the National Comprehensive
Care Network / Pfizer.
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CIBMTR 2015 Annual Report
2.0 WHAT WE DO
2.5 BIOINFORMATICS RESEARCH PROGRAM
The Bioinformatics Research Program provides
expertise in, and conducts research on,
translational and operational bioinformatics.
Program Activities
Current Bioinformatics
Research Goals
Develop pipelines to analyze Next
Generation Sequencing typing data,
including full-gene HLA, KIR, and genomewide sequencing, to refine our
understanding of genetic matching
Investigate the role of genetic ancestry in
transplantation, including the best way to
match individuals with multiple races in
their family tree
Develop data standards and tools for
making immunogenetic data portable for
research and clinical use
Investigate HLA data from other countries
to better understand global frequencies and
improve matching
Develop methods for HLA association
studies
Publications
In 2015, Bioinformatics study investigators
published 9 manuscripts in peer-reviewed
journals. A complete list of program
publications is provided in Appendix D4.
Key Bioinformatics Publications
this Year
Slater N et al. Power laws for heavy-tailed
distributions: modeling allele and
haplotype diversity for the NMDP. PLoS
Computational Biology. 11(4):e1004204.
Epub 2015 Apr 22. PMC4406525.
Besse K et al. On modeling HLA-identical
sibling match probability for alloHCT:
estimating the need for an unrelated
donor source. Biology of Blood and Marrow
Transplantation. Epub 2015 Sep 5.
Buck K et al. 7/8 and 9/10 or better high
resolution match rate for the Be The
Match® Unrelated Donor Registry. Biology
of Blood and Marrow Transplantation. Epub
2015 Dec 24.
Funding
Support for the Bioinformatics Research
Program is primarily provided by the grant #
N00014-14-1-0848 from the Office of Naval
Research as well as several grants from the
NIH.
How to Get Involved
For more information about the Bioinformatics
Research Program, visit the NMDP/Be The
Match Clinical Bioinformatics webpage or
contact Martin Maiers, Director, at
mmaiers@nmdp.org or 612.627.5892.
Presentations
Bioinformatics study investigators presented
11 abstracts (5 oral and 6 poster) at national
and international conferences in 2015. A
complete list of CIBMTR presentations is
provided in Appendix E.
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CIBMTR 2015 Annual Report
2.0 WHAT WE DO
2.6 STATISTICAL METHODOLOGY RESEARCH PROGRAM
The CIBMTR has enjoyed a positive,
collaborative association with the Division of
Biostatistics in the MCW Institute for Health
and Society since 1980, an association that is a
distinctive asset and crucial to the success of
CIBMTR research. This long-standing
relationship has many benefits. Biostatisticians
ensure the statistical integrity of CIBMTR
scientific activities, contribute to results in
articles on HCT-related statistical issues for
clinical audiences, and support Working
Committee study investigators in developing
scientific study protocols using CIBMTR data.
CIBMTR biostatisticians have pioneered novel
methodologic approaches to analyzing HCT
data.
Program Activities
HCT is a complex process with multiple
competing risks and dramatic changes in the
risks of specific events over time. The CIBMTR
has developed and evaluated the statistical
models used in HCT research and helped guide
the research community in appropriate
application and interpretation of these
sophisticated models.
Statistical Methodology
Research Goals
Develop new statistical models
Compare new statistical models with
existing solutions using the CIBMTR
Research Database
Publications
In 2015, PhD-level biostatisticians in the
Statistical Methodology Research Program
published 4 peer-reviewed manuscripts and 1
editorial. A complete list of program
publications is provided in Appendix D5.
Key Statistical Methodology
Publications this Year
Wang T et al. A re-formulation of
generalized linear mixed models to fit
family data in genetic association studies.
Frontiers in Genetics. 6(120):1-10. Epub
2015 Mar 31. PMC4379931.
Eriksson F et al. The proportional odds
cumulative incidence model for competing
risks. Biometrics. 2015 Sep 1; 71(3)687-695.
Epub 2015 May 26. PMC4608382.
Brazauskas R, Logan BR. Observational
studies: matching or regression? Biology of
Blood and Marrow Transplantation. Epub
2015 Dec 19.
Funding
Support for the Statistical Methodology
Research Program is primarily provided by the
NIH grant # U24CA076518 from the NCI,
NHLBI, and NIAID and the HRSA contract
# HHSH250201200016C.
How to Get Involved
During the BMT Tandem Meetings in February,
PhD-level biostatisticians plan and present
educational sessions related to statistical
design and analysis, and they provide 1:1
statistical consultation to researchers writing
proposals or developing protocols for CIBMTR
studies. Any interested individual may
participate in these sessions. Additionally, the
MCW Division of Biostatistics presents a
lecture series and a seminar series throughout
the year in Milwaukee.
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CIBMTR 2015 Annual Report
2.0 WHAT WE DO
2.7 STEM CELL THERAPEUTIC OUTCOMES DATABASE (SCTOD)
The CIBMTR administers the SCTOD for the
HRSA-sponsored C.W. Bill Young Cell
Transplantation Program, established by the
Stem Cell Therapeutic and Research Act of
2005. Continued support for the SCTOD is
provided through the Stem Cell Therapeutic
and Research Reauthorization Act of 2010.
C.W. Bill Young Cell Transplantation
Program Goals Fulfilled by the SCTOD
Collect, analyze, and report outcomes
data for all allogeneic transplants and
other therapeutic uses of blood stem
cells
Publicize information about HCT to
patients, families, health care
professionals, and the public
Define better processes for identifying
unrelated matched marrow donors, PBSC
donors, and cord blood units through
one electronic system
Increase availability of unrelated adult
volunteer donors and cord blood units
Expand research to improve patient
outcomes
Program Activities
Annually, the CIBMTR publishes HCT volumes
and performance data by transplant center
and provides public access to this information
via the HRSA Blood Cell Transplant website.
Center-Specific Volumes and Survival
Analysis. As part of the contract to operate the
SCTOD, the CIBMTR provides the annual
volume of transplants performed at each
center and performs a center-specific survival
analysis comparing the one-year survival rates
among US centers. The report assesses
transplants from both related and unrelated
SCTOD Contract Requirements
Collect HCT outcomes data for:
• All allogeneic HCTs performed in the
US using related or unrelated donors
• All allogeneic HCTs worldwide that
use grafts procured through the C.W.
Bill Young Cell Transplantation
Program
• Clinical applications of hematopoietic
stem cells other than hematopoietic
cell recovery
Use the data collected for the SCTOD to
evaluate the performance of transplant
centers
Provide specific SCTOD data to the public
Collect a basic set of data for analyses of
program use, center-specific outcomes,
donor registry, cord blood inventory size,
and patient access to HCT
Establish a Related Donor-Recipient
Research Sample Repository (Section 2.2)
donors. The most recent report was finalized
in September 2015 and contains information
on all first allogeneic transplants performed in
US centers from January 1, 2011, through
December 31, 2013.
Center Outcomes Forums. The CIBMTR has
conducted 4 Center Outcomes Forums to
engage relevant stakeholders in the centerspecific outcomes reporting process. The most
recent meeting was held in June 2014 and
generated recommendations to improve risk
adjustment, enhance future collection of
relevant data elements, and develop tools to
enhance centers’ quality improvement efforts.
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CIBMTR 2015 Annual Report
Quality of Life Assessments. In 2011, the
CIBMTR launched a pilot program at 5 adult
and 3 pediatric transplant centers. The
principal goal was to test center-based
recruitment of patients to a quality-of-life data
collection program, followed by
communication between the CIBMTR and the
patient to collect longitudinal quality-of-life
information. This pilot program is unique in
that the CIBMTR collects data directly from
patients after HCT. Accrual closed in 2013 with
390 patients enrolled. Data analysis is in
progress.
Cellular Therapies for Regenerative Medicine
(CTRM). The CTRM data repository tracks
novel uses of blood stem cells. The SCTOD
contract mandates data collection on uses of
cells found in bone marrow, peripheral blood,
and umbilical cord blood for alternative
therapeutic applications, including
regenerative medicine.
The CTRM data repository captures uses of
cells for the treatment of diseases without the
intention of replacing the recipient’s
hematopoietic function. These therapies
include, but are not limited to, treatment of
malignancies as well as infectious,
cardiovascular, rheumatologic, neurologic,
musculoskeletal, and endocrinologic diseases
with the intent to improve organ function. As
of November 30, the CTRM data repository
includes data for 983 patients.
The CIBMTR anticipates the expansion of the
cellular therapy field with the use of not only
hematopoietic derived cells but also cells from
other tissues; therefore, it is expanding the
capability and flexibility of data collection in
this rapidly changing area. In October, the
CIBMTR held a Cellular Therapy Forum
(Section 2.1.2) to discuss how to further
develop its cellular therapy registry.
2.0 WHAT WE DO
Study Summaries for Patients. In conjunction
with Be the Match’s Patient and Health
Professional Services and the Consumer
Advocacy Committee, the CIBMTR publishes
lay summaries of CIBMTR publications for
patients and their loved ones. In 2015, the
CIBMTR published 12 patient-friendly research
summaries.
Funding
Support for the SCTOD is provided by the HRSA
contract # HHSH250201200016C.
How to Get Involved
All US centers performing allogeneic HCTs
provide data to the CIBMTR for the SCTOD.
These data are used to generate reports,
which are distributed to transplant center
medical directors and posted on the HRSA
Blood Cell Transplant website.
Publicly Available Reports developed
by the CIBMTR for the SCTOD
Transplant Outcomes
• US Patient Survival Report
• US Transplant Data by Center Report
• US Transplant Data by Disease Report
Transplant Activity Report
These reports are available on the HRSA
Blood Cell Transplant website
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CIBMTR 2015 Annual Report
2.0 WHAT WE DO
2.8 CORPORATE PROGRAM
The CIBMTR Corporate Program provides
opportunities for industry collaborators to
access CIBMTR data and statistical support to
address questions specific to their business
needs through Corporate Membership as well
as Corporate Studies and Projects.
Corporate Membership. The CIBMTR
Corporate Membership program provides a
variety of resource materials to corporations
needing access to the most current and
comprehensive data on HCT. These materials
are useful for Marketing Managers, Medical
Directors, Research Directors, Product
Managers, Case Managers, and Transplant
Coordinators. There are four Corporate
Membership levels available, each described
on the CIBMTR Corporate Membership
Program webpage.
Corporate Membership Benefits
CIBMTR Report on Survival Statistics for
BMT
Center Volumes Dataset
Worldwide CIBMTR Directory of BMT
Physicians
Corporate Studies and Projects. Corporate
partners may contract with the CIBMTR to
conduct a study, support a project involving
more complex analyses, or license a specified
data set. Organizations interested in funding a
study, such as one comparing HCT with one or
more non-HCT therapies, or using historical
controls, can negotiate with the CIBMTR for
data and / or expert statistical analyses.
Program Activities
The CIBMTR engaged in 8 studies with
corporate partners in 2015. Currently 14
organizations participate in the CIBMTR
Corporate Membership program, including 9
that joined this year.
How to Get Involved
If you would like to learn more about the
CIBMTR Corporate Program, visit the CIBMTR
Corporate Membership webpage or contact
Sherry Fisher, Director of Advancement, at
slfisher@mcw.edu or 414.805.0687. If you are
a Corporate Member requesting analyses,
please complete the Corporate Member
Information Request Form.
Reduced registration rates at CIBMTR
meetings and educational forums,
including the BMT Tandem Meetings
Access to CIBMTR data and resources
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CIBMTR 2015 Annual Report
3.0 HOW WE SHARE KNOWLEDGE
3.0 HOW WE SHARE KNOWLEDGE
The CIBMTR is committed to sharing the data
we collect as well as the information and
knowledge produced from our data and our
extensive collaborations with investigators in
the HCT field.
The CIBMTR shares its knowledge in different
ways. To determine the best way to access
specific types of CIBMTR knowledge, review
Figure 3.1 and Tables 3.2-3.5.
Figure 3.1. How to Access CIBMTR Knowledge
Details provided in Tables 3.2-3.5.
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CIBMTR 2015 Annual Report
Table 3.2. How to Access CIBMTR
Information*
Information
GENERAL
In addition to reviewing this report,
access the Summary of Accomplishments
on the Administrative and Progress
Reports webpage. Read editions of the
quarterly newsletter on the Newsletters
webpage, and email cibmtr-news@mcw.
edu to be added to the electronic
distribution list.
ACTIVITIES
Review Section 2 or visit the What We
Do webpage. Visit the Studies webpage,
SCTOD webpage, or Corporate Support
webpage to learn more about CIBMTR
research programs, the SCTOD, or
Corporate Program, respectively.
PUBLICATIONS
Review the CIBMTR’s >1,000 publications
on the Publication List webpage. For lay
summaries of selected CIBMTR
publications, written specifically for
patients and the lay public, visit the
Study Summaries for Patients webpage.
MEETINGS
Visit the BMT Tandem Meetings
webpage to view agendas, register,
reserve housing, and submit abstracts.
TRAINING
Review Section 3.4 or visit the Training
and Reference webpage to access the
Center Reference Guide, Forms
Instruction Manual, FormsNet and AGNIS
trainings, and online courses.
OTHER
Email contactus@cibmtr.org.
3.0 HOW WE SHARE KNOWLEDGE
Table 3.3 How to Access CIBMTR Data*
Data
TYPES
Review the baseline and follow-up data
available for recipients and donors on
the Types of Data Available for Research
or Request webpage.
STANDARD REPORTS
Access the Summary Slides, BMT Survival
Statistics Report, Center Transplant
Activity Report, Patient Transplant
Outcomes Reports, and Center-Specific
Survival Reports via Table 3.6 or on the
Slides and Reports webpage.
ELECTRONIC RETURN OF CENTER
Utilize the Data Back to Centers
application on the Portal site to
download TED-level variables that have
been validated and processed in the
CIBMTR Research Database.
RESEARCH STUDY
Propose a study as explained on the How
to Propose a Study webpage, or
participate in one of the existing studies
listed on the Working Committee Study
Lists webpage.
CORPORATE ANALYSIS
Complete the Corporate Member
Information Request Form.
CUSTOM ANALYSIS
Complete the Custom Information
Request Form.
OTHER
Email inforequest@mcw.edu.
*If you are unable to access items using the electronic
links provided, enter the underlined words into a
general search engine or the search engine at the top of
the CIBMTR website (cibmtr.org).
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CIBMTR 2015 Annual Report
Table 3.4 How to Access CIBMTR Tools*
Tools
DISEASE RISK INDEX ASSIGNMENT
TOOL
Access this tool on the DRI Assignment
Tool webpage to categorize patients
undergoing allogeneic HCT for
hematologic malignancy by disease risk.
PATIENT ONE-YEAR SURVIVAL
CALCULATOR FOR ALLOGENEIC
TRANSPLANTS
Transplant Center Medical Directors may
access this tool on the Portal site to
predict one year survival for individual
allogeneic HCT recipients.
3.0 HOW WE SHARE KNOWLEDGE
Table 3.5 How to Access CIBMTR
Biospecimens*
Biospecimens
SAMPLES TYPES AND INVENTORY
Determine the >2 million samples
available in the Research Repository via
the Sample Types and Inventory
Summary webpage.
REQUESTING SAMPLES
For studies that include recipient clinical
outcome data, propose a study as
explained on the How to Propose a Study
webpage.
For studies that do not include clinical
outcome data, review the How to
Request Samples from the Research
Sample Repository webpage.
OTHER
Email research-repos@nmdp.org.
*If you are unable to access items using the electronic links provided, enter the underlined words into a general search
engine or the search engine at the top of the CIBMTR website (cibmtr.org).
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CIBMTR 2015 Annual Report
3.0 HOW WE SHARE KNOWLEDGE
Table 3.6. Standard Reports Published by the CIBMTR
Month(s)
Released
Report Title
Description
Format Accessibility*
CIBMTR Summary
Slides
Charts and figures summarizing current uses
and outcomes of allogeneic and autologous
HCT; developed in conjunction with the BMT
Tandem Meetings
February
PPT
Published on the CIBMTR Summary Slides
webpage
CIBMTR Progress
Report
Information on the CIBMTR's goals and
achievements as well as operational details
on how the CIBMTR is funded, supported,
promoted, and maintained
February
PDF
Published on the CIBMTR Administrative
and Progress Reports webpage
CIBMTR Report of
Survival Statistics
for BMT
Highly detailed report on survival statistics
that describes use and outcome of
autologous and allogeneic HCT in the >500
centers that have participated in the CIBMTR
September
Word
CIBMTR Summary
High level summary of CIBMTR fiscal year
of Accomplishments accomplishments and high impact
publications
September
PDF
Published on the CIBMTR Administrative
and Progress Reports webpage
US Centers Annual
Transplant Activity
Report
Dataset containing center-specific pretransplant patient-, disease-, and transplantrelated characteristics data for nearly all
allogeneic and a majority of autologous HCTs
performed in the US annually since 2008
September
PDF
Published on the HRSA Blood Cell
Transplant website
US Patient CenterSpecific Survival
Report
Comparison of observed to expected oneyear survival rates among centers in the C.W.
Bill Young Cell Transplantation Program
network; evaluates outcomes for transplants
using both related and unrelated donors
December
Web
Published on the Be The Match
Transplant Center Directory webpage;
available as a Word document upon
request to inforequest@mcw.edu
Via Corporate Membership Program
(Section 2.8) or by request from
physicians for making treatment decisions
or clinical investigators planning clinical
studies to inforequest@mcw.edu
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CIBMTR 2015 Annual Report
3.0 HOW WE SHARE KNOWLEDGE
Month(s)
Released
Report Title
Description
Format Accessibility*
US Patient
Transplant
Outcomes
Disseminated in 3 different reports:
• US Patient Survival Report: 100-day, 1year, and 3-year survival rate estimates for
US HCT recipients by disease and donor
type
• US Transplant Data by Center Report:
Number of bone marrow and cord blood
transplants performed at a specific
transplant center
• US Transplant Data by Disease Report:
Number of bone marrow and cord blood
transplants for a specific disease
December
Web
Published on the HRSA Blood Cell
Transplant website
US Allogeneic
Transplant Activity
Report
Report containing patient, disease, donor
HLA match, donor age, and gender match
information for allogeneic transplant activity
in the US since 2010
January
April
July
October
PDF
Via Corporate Membership Program
(Section 2.8)
CIBMTR Newsletter
Articles regarding Working Committees, the
SCTOD, data management and collection, and
noteworthy events in the HCT community
February
May
August
November
Web
Published on the CIBMTR Newsletters
webpage and distributed via email;
contact cibmtr-news@mcw.edu to be
added to the distribution list
Study Summaries
for Patients
Summaries of CIBMTR research publications
written for patients and others in the lay
public
Ongoing
PDF
Published on the CIBMTR Study
Summaries webpage
*If you are unable to access items using the electronic links provided, enter the underlined words into a general search engine or the search engine at the top of the
CIBMTR website (cibmtr.org).
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CIBMTR 2015 Annual Report
3.0 HOW WE SHARE KNOWLEDGE
3.1 INFORMATION REQUEST SERVICE
The CIBMTR Information Request Service
provides timely access to data on
transplantation to patients, physicians,
hospitals, pharmaceutical companies,
insurance companies, and others involved in
healthcare. Requests range from simple
queries of patient, disease, and transplant
frequencies to those with greater complexity
involving specific data combinations and / or
statistical analysis of outcomes.
Potential Reasons for
Information Requests
Self-education and decision making
Patient counseling or clinical
decision making
Presentation support
Transplant center assessments
Clinical trial planning
Market assessments
Coordinating Center staff members fulfill
requests related to clinical decision making
within three days and most other requests
within three weeks. If a request will take more
than an estimated four weeks to fulfill, a
Coordinating Center staff member will contact
the requestor to discuss an appropriate
timeline.
Table 3.7. Data Requests Addressed by the
CIBMTR in 2015
Requestor
Number of
Requests
Physician / Researcher
352
Patient or Relative
41
Pharmaceutical / Biotech
Company
38
Market Research Firm
22
Student
6
Patient Advocacy Group
4
News Media
4
Federal Government Agency
1
Cord Blood Bank
1
TOTAL
469
How to Access
For more information about requesting data
from the Research Database, visit the CIBMTR
How to Request Data webpage. If you would
like a one-time, custom analysis, complete the
Custom Information Request Form. If you have
questions about requesting CIBMTR data,
please contact inforequest@mcw.edu.
Accomplishments
In 2015, the CIBMTR fulfilled 469 requests for
information and data (Table 3.7).
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CIBMTR 2015 Annual Report
3.0 HOW WE SHARE KNOWLEDGE
3.2 INTERNET PRESENCE
The CIBMTR Internet presence provides the
scientific community and the public with
access to HCT information. Current websites
include general information about HCT and
CIBMTR activities; training and support; a
shared communications and collaborative
environment for member centers; and secure
web access to CIBMTR data for Working
Committees, transplant centers, scientific
investigators, and CIBMTR staff.
3.2.1 CIBMTR Public Website
The CIBMTR public website (cibmtr.org) is
unrestricted and provides information about
the CIBMTR and its research. It supports the
Working Committees and BMT CTN with
information regarding proposal submission,
access to a listing and summaries of all studies
in process, and access to a summary of all
CIBMTR publications. The website facilitates
data and information requests, and it provides
access to all current and past data collections
forms, training manuals, and videos as well as
other materials for both investigators and data
professionals. The website information is, in
part, supported by DISCO (Data and
Information for Statistical Center Operations),
an application which maintains data on >750
studies, >1,000 publications, and >1,800
authors and their institutions at time of
publication. In 2015, the CIBMTR public
website had approximately 418,000 unique
page views.
About CIBMTR
Administrative and Progress Reports
(663 unique page views in 2015)
Provides access to the CIBMTR’s annual
Progress Report, annual Summary of
Accomplishments, and Manual of Operations.
Studies
Working Committee Studies Lists
(4,835 unique page views in 2015)
A summary of the planned, in-progress, and
recently published clinical outcomes studies
for each Working Committee.
Meetings
Annual BMT Tandem Meetings Materials
(34,073 unique page views in 2015)
Provides access to agendas, handouts, and
educational materials from specific meetings
at the BMT Tandem Meetings: Working
Committee Meetings and Clinical Research
Professionals / Data Management
Conferences.
Reference Center
Summary Slides
(10,654 unique page views in 2015)
Includes charts and figures summarizing
current uses and outcomes of allogeneic and
autologous HCT.
Web-based US Transplant Reports
(31,964 unique page views in 2015)
Directs users to the Be The Match US Center
Listing Report and customizable reports of
patient survival and transplant available
through the HRSA Blood Cell Transplant
website.
Publication List
(5,836 unique page views in 2015)
Searchable descriptive list of >1,000
publications resulting from the use of CIBMTR
data and statistical resources.
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CIBMTR 2015 Annual Report
3.0 HOW WE SHARE KNOWLEDGE
Newsletter
(3,199 unique page views in 2015)
Published 3-4 times per year. Articles feature
updates on Working Committees, the SCTOD,
data management and collection, and
noteworthy events in the HCT community.
Data Collection Forms
(47,303 unique page views in 2015)
Provides access to current and retired versions
of the forms used by the CIBMTR to collect
standard data elements for all transplant
recipients.
Patient Resources
(4,590 unique page views in 2015)
Includes lay summaries of CIBMTR research
articles as well as post-transplant care
recommendations for adult and pediatric
autologous and allogeneic HCT recipients to
help patients and clinicians understand and
plan for the specialized care of transplant
recipients. 12 lay summaries were published
in 2015.
Training and Reference
(68,004 unique page views in 2015)
Provides access to a wide variety of CIBMTR
data management training and reference
materials.
Statistical Resources
(4,183 unique page views in 2015)
Provides access to resources offered through
the unique partnership between the CIBMTR
and MCW Division of Biostatistics, including
biostatistical publications, a series of statistical
lectures targeted at basic and clinical
investigators, and research tools, such as the
Disease Risk Index Assignment Tool.
Data Management
Data Management Manual
(38,071 unique page views in 2015)
A comprehensive reference document for
completing CIBMTR data collection forms. The
manual also details reporting requirements,
describes protocols and the consent process,
and includes downloadable versions of report
forms.
3.2.2 CIBMTR Collaborative Site
The CIBMTR Collaborative site
(collaborate.cibmtr.org) uses the SharePoint
Enterprise Collaboration platform to promote
cooperative work among CIBMTR staff
members and provides a communication
platform for specific studies and initiatives.
This site is secured by username and
password, and user-specific security
credentials are assigned centrally.
The CIBMTR uses the site for storing and
sharing protocol and consent documents,
donor / recipient tracking tools, confidential
committee information, data, manuscript
drafts, and other relevant information. While
only two Working Committees currently use
the Collaborate site on a regular basis, it is
available to all Working Committees for
sharing information.
Data Back to Centers Application
(628 unique page views)
Links to the Data Back to Centers (DBtC)
application that provides CIBMTR member
centers the ability to retrieve all the TED-level
data their center has reported to the CIBMTR
through FormsNet or AGNIS.
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CIBMTR 2015 Annual Report
3.0 HOW WE SHARE KNOWLEDGE
3.2.3 CIBMTR Portal Site
The CIBMTR Portal site (portal.cibmtr.org)
delivers applications and data to CIBMTR
transplant centers and other partners. In 2015,
unique, external visitors viewed 2,675 portal
pages. Four applications are currently hosted
on this site:
Data Back to Centers
The current DBtC application provides
authorized users the ability to download
CIBMTR TED-level data variables for their
centers. The data have been validated and
processed in the CIBMTR Research Database
and are reviewed and refreshed quarterly.
Legacy International Bone Marrow Transplant
Registry (IBMTR) data from as far back as 1964
and some legacy NMDP/Be The Match data
from as far back as 1987 are available. In 2015,
628 unique, non-CIBMTR visitors viewed 914
DBtC pages and downloaded data 418 times.
In Spring 2016, the CIBMTR plans to release an
enhanced DBtC (eDBtC) application that will
give centers access to both TED- and CRF-level
source data as well as a variety of analytic
tools via a user-friendly application called
Qlikview.
Center Volumes Portal
The Center Volumes Portal allows centers to
preview; correct, if necessary; and approve
center volume data published annually to the
HRSA Blood Cell Transplant website. The
CIBMTR gives centers access to display and
download the previous six years (2009-2014)
of volume data as well as the current year
under review (2014). In 2015, 188 unique,
external visitors viewed 706 Center Volumes
Portal pages.
Patient One-Year Survival Calculator –
Allogeneic Transplants
Accessible by medical directors, the Patient
One-Year Survival Calculator for Allogeneic
Transplants provides centers with a tool to
predict one year survival for individual
allogeneic HCT recipients. The calculator data
are updated annually to reflect new
information contained in the center outcomes
analysis. In 2015, 448 unique, non-CIBMTR
visitors viewed 1,357 survival calculator
pages.
Qlikview
In 2015, the CIBMTR selected Qlikview, a third
party business intelligence tool, to provide
transplant centers with self-service access to
their data and information, including
descriptive statistics, outcomes, and trends.
Using Qlikview, centers will be able to more
readily visualize their data in predefined
dashboards, interact with their data through
ad hoc analytics, and export their data to files
that will support further analysis. The CIBMTR
will introduce two Qlikview applications at the
2016 BMT Tandem Meetings: eDBtC, which
will provide transplant centers with access to
their TED- and CRF-level data, and CenterSpecific Analysis Tool, which will provide
transplant centers with access to their SCTOD
database data.
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CIBMTR 2015 Annual Report
3.0 HOW WE SHARE KNOWLEDGE
3.2.4 Be The Match Public Website
3.2.6 HRSA Blood Cell Transplant Website
The Be The Match Public website
(bethematch.org) is designed for patients and
families, donors, and supporters. It
incorporates detailed information about
transplantation and donation written for the
public. The website provides scientific
information in lay terms for donors related to
the donation process and for patients related
to specific diseases, various treatment options,
the process of transplantation, and life after
transplant. It also addresses concerns related
to specific populations, including children and
caregivers. The CIBMTR collaborates with
NMDP/Be The Match to provide content for
several areas of this website, including data for
the US Center Listing Report.
The HRSA Blood Cell Transplant website
(bloodcell.transplant.hrsa.gov) provides
information for the public, physicians, and
other constituents. It incorporates transplant
resources, donor information, and cord blood
information as well as research, data, and
outcomes. CIBMTR data and research findings
are incorporated in numerous ways, including
through CIBMTR-created reports:
US Center Listing Report
Transplant Center Directory
Provides transplant center specific information
about facilities, personnel, diseases treated,
cost, and transplant experience, including the
number of transplants performed and survival
rates by age, disease type, and disease stage.
3.2.5 Be The Match Clinical Website
The Be The Match Clinical website
(bethematchclinical.org) is designed for
clinicians, network participants, payors, and
bioinformatics professionals. For clinicians, the
website provides access to evidence-based
tools, clinical guidelines, outcomes data, and
education courses on HCT. The website also
provides information specific to types of
network participants: transplant centers,
donor centers, apheresis and collection
centers, and cord blood banks. For payors, the
website offers information to help individuals
understand BMT, determine coverage, and
answer employer and patient questions.
Related to bioinformatics, the website
provides resources for immunogenetic-focused
research and operational bioinformatics as
well as frequently used HLA tools.
Transplant Outcomes and Data
US Patient Survival Report
Provides disease-specific post-HCT survival
estimates by the length of time after
transplant: 100 days, 1 year, and 3 years.
Survival estimates are also available by patient
age, patient gender, patient race, or cell
source.
Transplant Data by US Center Report
Displays the number of adult donor and cord
blood transplants performed at a specific
transplant center.
Transplant Data by Disease Report
Displays the number of adult donor and cord
blood transplants reported for a specific
disease. Totals are also available by patient
age, patient gender, patient race, cell source,
and the year the transplant was performed.
Transplant Activity Report
Displays the number of transplants performed
at US transplant centers, including autologous
as well as related and unrelated allogeneic.
Numbers are also available by patient age,
patient gender, patient race, cell source,
disease, transplant center location by state,
and year in which the transplant was
performed.
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CIBMTR 2015 Annual Report
3.2.7 Other Applications and Data Exchange
Standards
The CIBMTR has 7 methods for sharing data.
The 4 hosted on the CIBMTR Portal site (DBtC,
Center Volumes Portal, Patient One-Year
Survival Calculator, and Qlikview) were
described in Section 3.2.3. The other 3
methods for sharing data are:
AGNIS
AGNIS (A Growable Network Information
System) allows participating centers to
electronically collect and share data with the
CIBMTR as well as others who link to AGNIS.
Data are entered once and then distributed
and synchronized among databases. In 2015, a
total of 12,873 forms for 1,840 patients were
submitted through AGNIS by 20 US transplant
centers and by EBMT for 47 of their affiliated
centers.
3.0 HOW WE SHARE KNOWLEDGE
Disease Risk Index Assignment Tool
In March 2015, the CIBMTR launched a Disease
Risk Index Assignment Tool developed by
investigators at the Dana Farber Cancer
Institute and validated in a large CIBMTR
study. It is intended for use by clinical
researchers. The tool was developed for the
primary outcome of overall survival after HCT
and, at present, only applies to adult patients
with hematologic malignancies. It is NOT
intended to give an accurate prognosis for
individual patients. In 2015, 1,370 unique,
non-CIBMTR visitors viewed the Disease Risk
Index Assignment Tool 3,764 times.
BRIDG
The BRIDG (Biomedical Research Integrated
Domain Group) Model is an information
model, representing a shared view of the
concepts of basic, pre-clinical, clinical, and
translational research. Common data elements
for certain standard CIBMTR forms have been
extracted and associated in the BRIDG model
to one of three contexts: recipient, donor, or
stem cell product. Future expansion of the
BRIDG model will add HCT content as the basis
for a physical database model, which will help
remove barriers that transplant centers
experience in electronic transfer of HCT data
to the SCTOD. It will provide a foundation
upon which centers and vendors can develop
their own in-house data systems and,
eventually, develop electronic medical record
integration engines to submit data to the
CIBMTR Research Database.
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3.0 HOW WE SHARE KNOWLEDGE
3.3 BMT TANDEM MEETINGS
The BMT Tandem Meetings are co-sponsored
with the ASBMT and are held annually in
February. They include 5 days of plenary
sessions, concurrent scientific sessions, and
other meetings. Reports on recent progress
and updates in basic science, translational
research, and clinical studies are targeted to
worldwide physicians, scientists, and other
health professionals with an interest in HCT.
2015 BMT Tandem Meetings
With 3,132 attendees from 47 countries, the
2015 BMT Tandem Meetings included 5
plenary sessions, 11 concurrent sessions, 108
oral abstracts, 2 poster sessions, 6 corporatesupported symposia, and 3 product theaters.
Continuing Medical Education (CME) and
Continuing Education credits were issued
through MCW to physicians and allied health
professionals. In addition to the extensive
scientific agenda, many educational
opportunities focused on young investigators
and other allied health professionals.
Clinical Research Professionals / Data
Management Conference
With almost 200 attendees, this conference
provided forms training, which increases the
accuracy with which CIBMTR forms are
completed.
BMT CTN Coordinators and Investigators
Meetings
With approximately 100 and 300 attendees,
respectively, these meetings focused on
treatment options; study management, such
as promoting studies and reporting adverse
events; processes, such as endpoint review;
and specific clinical trials.
IT Forum
With almost 100 attendees, this forum
discussed the Research Data Life Cycle and
various ways to share data, including from
electronic medical records via BRIDG.
BMT Center Administrators Conference
With approximately 165 attendees, this
conference focused on many topics related to
quality and outcomes, including benchmarking
and key metrics, such as readmission rates, as
well as Medicare coverage and workforce
capacity.
BMT Pharmacists Conference
With almost 200 attendees, this conference
presented the latest research and best
practices with a focus on specific diseases and
preparative regimens.
Transplant Nursing Conference
With almost 500 attendees, this conference
presented the latest research as well as
disease-specific information and
communication techniques.
BMT Clinical Education Conference
This conference is designed for Nurse
Practitioners, Physician Assistants, Fellows,
and Junior Faculty. With almost 200
attendees, the conference focused not only on
the latest clinical research but also informed
consent and mental health.
2016 BMT Tandem Meetings
The 2016 BMT Tandem Meetings will include 5
plenary sessions, 9 concurrent sessions, 133
oral abstracts, 2 poster sessions, 5 corporatesupported symposia, and 5 product theaters.
They are expected to attract approximately
3,200 attendees.
Page | 39
CIBMTR 2015 Annual Report
3.0 HOW WE SHARE KNOWLEDGE
3.4 DATA MANAGEMENT TRAINING
The CIBMTR has developed comprehensive,
secure and efficient applications to allow you
to electronically submit data to the CIBMTR.
Visit the CIBMTR Data Management Training
and Reference webpage to access resources.
Center Reference Guide
Learn about participation in CIBMTR research,
center membership, access to FormsNet, data
manager education, mentor program, forms
submission process and many useful tips and
links.
Manuals
Find the answers to your data submission
questions by accessing the Forms Instructions
Manual, which includes general instructions
and instructions for each form type.
FormsNet
Learn how to submit data to the CIBMTR via
the FormsNet application, a secure clinical
research management system, which is in
compliance with SCTOD requirements.
Conference Materials
Access meeting materials as well as audio and
visual presentations on the form submission
process presented at Clinical Research
Professionals / Data Management
Conferences.
AGNIS
Learn how to retrieve and transmit form data,
extracted directly from your own institution’s
database, directly to the FormsNet application
using AGNIS, a secure, standards-based
system.
Legacy Data
Review retired data manuals, forms, and other
archived documents for reference purposes
and to assist in making changes to legacy data.
Adverse Events
Learn how to report adverse events and
product issues through FormsNet.
Newsletters and eBlasts
Read archived issues of the Data Matters
Training Newsletter and eBlasts.
Tip Sheets
Access sheets providing tips and instructions
for various CIBMTR forms.
Online Training
Review educational modules developed for
new and seasoned data managers through the
NMDP/Be The Match Learning Center.
Learning Center Courses
Data Back to Centers Overview
HLA SERIES
Introduction to HLA
HLA Reporting (Form 2005)
Basic Biology of HLA
Advanced Biology of HLA
ESSENTIAL FORM SERIES
Baseline Form 2000
CRID 2804
Form 2400 Pre-TED
Indication for CRID Assignment (Form
2814)
Infusion Data (Form 2006) Reporting
Overview
Reporting Preparative Regimen on PreTED (Form 2400) and Baseline (Form
2000)
DISEASE SPECIFIC SERIES
Form 2016 / 2116 Plasma Cell Disorders
Form 2018 / 2118 Lymphoma
Page | 40
CIBMTR 2015 Annual Report
4.0 HOW WE COLLECT AND MANAGE DATA
4.0 HOW WE COLLECT AND MANAGE DATA
4.1 RESEARCH DATA LIFE CYCLE
The Research Data Life Cycle (Figure 4.1)
describes the path of data from the point of
capture to its ultimate use in analysis,
reporting, and publication.
The process begins with data collection. Most
centers enter data in FormsNet, a web
application now in its third generation. Centers
that have implemented local or third party
systems can also capture and submit data
electronically using AGNIS. An overriding goal
of these applications is to ease the data
capture burden on the centers.
Data Sharing completes the cycle, providing
data for analysis that have been collected and
curated to ensure research value. These data
are extracted from the Research Database in
monthly and quarterly retrievals to serve a
range of research and stakeholder needs. The
data retrievals provide the basis for research
study data files, reports, and externallyrequested datasets. TED-level data are also
directly available to centers through use of the
DBtC application (Section 3.2.3).
Following collection, data undergo quality
assessment and validation and are extracted 4
times per month and loaded into the CIBMTR
Research Database.
Figure 4.1. Research Data Life Cycle
Abbreviations: AGNIS = A Growable Network Information System, CRID = CIBMTR Recipient Identification Number,
CRF = Comprehensive Report Form, FN = FormsNet, IDW = Integrated Data Warehouse, RDB = Research Database
Page | 41
CIBMTR 2015 Annual Report
4.0 HOW WE COLLECT AND MANAGE DATA
4.2 COLLECTING AND STORING DATA
4.3 ENSURING DATA QUALITY
4.2.1 FormsNet
4.3.1 Continuous Process Improvement
More than 95% of data collected by the
CIBMTR is submitted electronically via
FormsNet, a comprehensive electronic data
submission system containing >240 forms
related to capturing HCT outcomes for donors
and recipients. The application was updated in
2015 to provide key enhancements supporting
operational efficiencies and enhanced data
collection. For instance, a more flexible
CIBMTR Recipient ID (CRID) Assignment Form
establishes a patient ID independent of
treatment, allowing the CIBMTR to expand
data collection to patients who receive cellular
therapy as well as non-HCT treatments. In
addition, the CIBMTR released several forms to
support data collection needs of the Radiation
Injury Treatment Network (RITN), which will
collect incident, medical history, and follow-up
data on casualties exposed to or contaminated
by radioactive material in the event of a
national radiation event.
Robust data collection is critical to the success
of the CIBMTR. The CPI program ensures
timeliness and completeness of data forms
submissions (Appendix H).
4.2.2 Research Database
The Donor Data Management Team oversees
submission of transplant donor forms from
NMDP/Be The Match donor, collection, and
apheresis centers. Donor CPI reports are
generated 4 times per year (January, April,
July, and October). To be compliant, centers
must submit 100% of the forms required for
that CPI period.
The CIBMTR Research Database now contains
information on >425,000 patients.
Submission of outcomes data is mandatory for
allogeneic HCTs in the US and those outside
the US that use a US donor; all other
submissions are voluntary. The CIBMTR
estimates that almost 100% of US allogeneic
transplants and about 80% of US autologous
HCTs are reported.
Recipient Forms
Transplant centers receive CPI reports 3 times
per year (January, May, and September),
listing the number of follow-up forms that
were due in the previous trimester and the
number and percentage of each submitted
within the trimester. A form is not officially
submitted until all errors are resolved and all
applicable information is submitted and
approved. To be compliant, centers must
submit ≥90% of forms due for the trimester,
for all unrelated donor transplants and for
related donor and autologous transplants that
have occurred since December 3, 2007.
Donor Forms
Page | 42
CIBMTR 2015 Annual Report
4.0 HOW WE COLLECT AND MANAGE DATA
4.3.2 Verification and Validation
FormsNet
When data are entered into FormsNet, a series
of entry level validation checks takes place to
ensure data consistency. This process flags
certain errors at the time of entry and allows
the CIBMTR to contact the center data
manager so errors can be corrected
immediately while source documents are
readily available. If a data field does not pass
the FormsNet validation checks, an error
comment is generated, and the data manager
is navigated to an error review page to review,
resolve, or override the unresolved errors.
Lastly, an error report is generated that lists
any unresolved errors as well as errors that
have been overridden.
Research Database
Data extracted from FormsNet and loaded to
the Research Database each month undergoes
comprehensive validation and verification.
These data are rigorously validated for
consistency, completeness, and uniqueness
using business rules implemented in custom
logic for the categories provided below.
Finally, the Data Quality Team reviews errors
and works with transplant centers to correct
data.
Extraction Validation Checks
Fields that cannot be null
Cross form consistency
Entry Level Validation Checks
Longitudinal consistency
Mandatory field validation
Logical relationships
Range validation
Cross form consistency
Within form consistency
Core field validations
Rules across these categories were updated
and tested as part of the recent Forms
Revision. The CIBMTR continues to work
toward reducing the number of data entry
errors. Currently, the rate of form rejection
due to inconsistently reported data is <2%,
which is attributed to recent enhancements in
transplant center education as well as to
enhanced validations built in at the point of
entry in FormsNet.
Page | 43
CIBMTR 2015 Annual Report
4.0 HOW WE COLLECT AND MANAGE DATA
4.3.3 On-Site Data Audit Program
On-going data audits are performed at all
CIBMTR participating transplant centers. The
audit compares data in source documents
maintained at the transplant center with data
contained in the CIBMTR Research Database.
Clinical Research Associates perform the onsite transplant center audits, spending 3-4
days at each center reviewing original source
documents. The overall audit process is
displayed in Figure 4.2.
The Foundation for the Accreditation of
Cellular Therapy (FACT) and the CIBMTR
agreed in 2015 to consolidate transplant
center data audits. Therefore, beginning in
2016, FACT auditors will use the results of the
CIBMTR data audit and discontinue use of the
current independent FACT data audit.
Consolidating audits of transplant center data
collection and reporting eases the reporting
and compliance burdens of transplant centers
and demonstrates the value of the CIBMTR’s
data collection and management to an
international accrediting agency.
In 2015, 62 centers were scheduled for audit
(48 domestic, 16 international). As of
December 31, 57 centers were notified of
their final audit results, including requested
corrective action follow-up. Of the centers sent
reports, 80% passed with ≤3% critical field
errors. Of the 11 centers that did not pass the
audit, 7 completed all required corrective
action; the remaining 4 centers are in the
process of completing requested corrective
action.
Figure 4.2. Audit Process
Page | 44
CIBMTR 2015 Annual Report
4.0 HOW WE COLLECT AND MANAGE DATA
4.4 PROTECTING PATIENTS AND DATA
4.4.1 Human Subjects / HIPAA Compliance
4.4.2 Information Security and Data Privacy
The CIBMTR is committed to the ethical
conduct of research. All Coordinating Center
personnel maintain Collaborative IRB Training
Initiative (CITI) certification. The NMDP/Be The
Match IRB, which is fully accredited by the
Association for the Accreditation of Human
Research Protection Programs, reviews all
human subject research conducted by the
CIBMTR. The CIBMTR maintains compliance
with the Health Insurance Portability and
Accountability Act (HIPAA) Privacy Rule, as
applicable. CIBMTR rules requiring the
registration of all consecutive HCT recipients
ensure the inclusion of women, minorities, and
children, so the Research Database population
includes women and minorities in the same
proportion as found in the general HCT
population. Children are included in most
CIBMTR studies; their inclusion is dependent
on the study focus.
The CIBMTR protects the data and information
received from transplant centers and patients.
The SCTOD contract requires specific
protections through minimum security
controls, policies, and standards. The CIBMTR’s
data systems are maintained in accordance
with the Federal Information Systems
Management Act of 2002, with information
security guidance provided by the National
Institute of Standards and Technology. In
accordance with National Institute of
Standards and Technology Special Publication
800-18, and supervised by HRSA’s Office of
Information Technology, the CIBMTR
maintains a System Security Plan that outlines
management, operational, and technical
controls.
Since 2008, the CIBMTR holds an Authority to
Operate from the Chief Information Officer of
HRSA. The certification was renewed in June
2015, and security audits are performed
annually, most recently in September 2015.
The NMDP/Be The Match also holds an
Authority to Operate from HRSA, ensuring
similar standards of information security are
applied to all CIBMTR and NMDP/Be The
Match systems. These controls, maintained by
the CIBMTR and NMDP/Be The Match, protect
the data and information in these systems in
ways beyond those required by HIPAA.
Page | 45
CIBMTR 2015 Annual Report
5.0 WHAT WE WILL DO NEXT
5.0 WHAT WE WILL DO NEXT
In 2016, the CIBMTR will continue to conduct
high quality research through a collaborative
process.
Specific plans are listed in Figure 5.1 and
Tables 5.2-5.4.
Figure 5.1. Plans for 2016
Enhance the
quality and scope
of CIBMTR data
Expand data
and knowledge
sharing
Increase
research
productivity
and scientific
impact
Details provided in Tables 5.2-5.4.
Page | 46
CIBMTR 2015 Annual Report
Table 5.2. Plans to Enhance Data
Enhance the quality and
scope of CIBMTR data
Further develop a cellular therapy
registry
Expand data collection to patients who
receive non-HCT treatments
Continually review data collection forms
for scientific content updates
Implement key data validations in
FormsNet, close to the point of data
capture
Implement consolidated transplant
center data audits with FACT to enhance
data monitoring while decreasing
reporting and compliance burdens on
transplant centers
Work toward an Integrated Data
Warehouse to strengthen flexibility of
data use and ease of data access
5.0 WHAT WE WILL DO NEXT
Table 5.3. Plans to Expand Knowledge
Sharing
Expand data and knowledge sharing
Implement two data sharing products
using Qlikview software applications to
enhance transplant centers’ self-service
access to their data and information
• eDBtC will provide centers with
access to a wide range of TED- and
CRF-level data
• Performance data tool will provide
centers with comparison data from
the SCTOD annual center-specific
analysis of posttransplant survival in
US centers
Publish easy to read summaries of key
HCT publications
Strengthen collaborations with
international partners to facilitate data
sharing
Provide onsite and online data
management training support for
transplant centers
Page | 47
CIBMTR 2015 Annual Report
5.0 WHAT WE WILL DO NEXT
Table 5.4. Plans to Increase Impact
Increase research productivity
and scientific impact
Focus on studies with highest scientific
impact and important clinical and policy
implications; limit accepted studies to a
number that can be completed in a timely
manner
Support Working Committee Chairs to be
active leaders in their committees
Regularly share metrics as a Working
Committee management resource
Expand use of outcomes data to assist in
the design, implementation, and longterm follow-up of clinical trials
Develop new statistical methodologies
Support Health Services Research
initiatives
Page | 48
CIBMTR 2015 Annual Report
2015 KEY ACCOMPLISHMENTS
2015 KEY ACCOMPLISHMENTS
CIBMTR by the Numbers
RESEARCH DATABASE
~400 participating centers
>425,000 patients
~21,000 new patients annually
PUBLICATIONS
>1,000 publications since inception
76 publications in 2015
38 from Working Committees
8 from BMT CTN
4 from Health Services Research
Program
9 from Bioinformatics Research
Program
5 from Statistical Methodology
Research Program
14 from Coordinating Center
(2 cross-listed between programs)
PRESENTATIONS
65 presentations in 2015 (41 oral and
24 poster)
25 abstracts (17 oral and 8 poster)
presented at the 2015 ASH
Annual Meeting
17 abstracts (13 oral and 4 poster)
presented at the 2015 BMT
Tandem Meetings
6 abstracts (4 oral and 2 poster)
presented at the 2015 EBMT
Annual Meeting
17 abstracts (7 oral and 10 poster)
presented at other national and
international conferences
Clinical Outcomes
Research Program
WORKING COMMITTEES
Administered 15 committees in which
2,300 worldwide researchers
participate
Collaborated with the 54 global experts
in the HCT field who voluntarily chair
the committees
Conducted 176 ongoing studies
Reviewed 193 new study proposals for
presentation at the 2016 BMT Tandem
Meetings, >75% of which were
submitted by new investigators
Presented 38 abstracts (26 oral and 12
poster) at national and international
conferences
Supported approximately 400 scientific
authors at 200 institutions worldwide
to publish research findings
Published 38 manuscripts in peerreviewed journals
CELLULAR THERAPIES AND NONTRANSPLANT THERAPY
Initiated a Cellular Therapies Task
Force charged with determining the
type and process for cellular therapies
data collection
Hosted a Cellular Therapies Forum to
develop recommendations for a
cellular therapy registry
Page | 49
CIBMTR 2015 Annual Report
Immunobiology
Research Program
Collected samples from 175 centers (128
transplant centers, 32 donor centers, and
15 cord blood banks)
Curated 12,656 samples in the Research
Repository (137,464 overall)
Completed high resolution HLA and
presence / absence KIR typing on 226
related and 2,772 unrelated HCT donor /
cord and recipient pairs
Distributed 8,770 samples to
investigators for various studies
Presented 5 abstracts (2 oral and 3
poster) at national and international
conferences
Published 6 manuscripts in peerreviewed journals
RESEARCH REPOSITORY
Added 4,392 unrelated recipient
samples (57,018 overall)
Added 1,264 related recipient samples
(5,377 overall)
Added 4,819 adult unrelated donor
samples (59,375 overall)
Added 1,258 related donor samples
(5,128 overall)
Added 923 unrelated cord blood
samples (10,566 overall)
2015 KEY ACCOMPLISHMENTS
Clinical Trials
Support Program
BMT CTN
Opened 3 new trials to accrual,
bringing the total number of launched
trials to 37
Accrued >1,100 patients to trials,
increasing the total number of accrued
patients to >8,500
Managed 12 open protocols with
overall accrual for open studies at
about 125% of projections
Presented 11 abstracts (8 oral and 3
poster) at national and international
conferences
Published 8 manuscripts in peerreviewed journals
RCI BMT
Opened 3 new trials to accrual,
bringing the total number of launched
trials to 15
Accrued just under 3,000 patients,
bringing the total number of accrued
patients to approximately 28,000
Presented 4 oral abstracts at national
and international conferences
Survey Research Group
Supported 8 active studies, and
participated in the development of
one upcoming study
Page | 50
CIBMTR 2015 Annual Report
Health Services
Research Program
Established the HCT Health Economics
Interest Group, which held its first
meeting at the 2015 BMT Tandem
Meetings
Opened a multi-center randomized
controlled study to evaluate the
effectiveness of an individualized
survivorship care plan template; 17
centers will participate in this study
Conducted a national survey of
community hematologists / oncologists
on referral practices, perceptions of HCT,
and education preferences to inform an
educational intervention on timing of
community-based referral for HCT
Completed two studies: Identifying HCT
patient housing and caregiver challenges
and potential interventions and The
financial impact of allogeneic HCT on
patient and family: a pilot study
Conducted >30 evaluations for the HRSA
Office of Patient Advocacy / Single Point
of Contact contract and NMDP/Be The
Match programs
Provided technical plain language writing
consultation; developed 3 easy-to-read
consent forms and 6 patient information
sheets for BMT CTN protocols
Presented 3 oral abstracts at a national
conference
Published 4 manuscripts in peerreviewed journals
2015 KEY ACCOMPLISHMENTS
Bioinformatics
Research Program
Developed guidelines for reporting HLA
and KIR genotyping via Next Generation
Sequencing
Investigated the role of genetic ancestry
in transplantation
Developed methods for HLA association
studies
Investigated HLA data from other
countries
Presented 11 abstracts (5 oral and 6
poster) at national and international
conferences
Published 9 manuscripts in peerreviewed journals
Statistical Methodology
Research Program
Developed new statistical models
Ensured the statistical integrity of
CIBMTR scientific activities
Contributed to results in articles on HCTrelated statistical issues for clinical
audiences
Supported Working Committee study
investigators in developing scientific
study protocols using CIBMTR data
Published 4 peer-reviewed manuscripts
and 1 editorial
Page | 51
CIBMTR 2015 Annual Report
2015 KEY ACCOMPLISHMENTS
SCTOD
Published annual Center-Specific Survival
Report, Transplant Center Volumes Data
for 2009-2013, and a Transplant Activity
Report for transplants performed 20092013
Began implementing recommended
changes to tools to enhance transplant
centers’ quality improvement efforts in
response to recommendations from the
2014 Center Outcomes Forum
Continued analysis of a quality of life
project, which is unique in that the
CIBMTR collected data directly from
patients after HCT
In conjunction with Be The Match’s
Patient and Health Professional Services,
published 12 lay summaries of CIBMTR
publications
Page | 52
CIBMTR 2015 Annual Report
APPENDIX A: TRANSPLANT CENTERS
APPENDIX A: TRANSPLANT CENTERS
Figure A.1. Location of Transplant Centers that Submit Data to the CIBMTR
Page | 53
CIBMTR 2015 Annual Report
APPENDIX A1: US CENTERS
APPENDIX A1: US CENTERS
The following table lists the US-based transplant centers that submited data to the CIBMTR Research
Database for matched unrelated donor (MUD) allogeneic, related donor allogeneic, and autologous
transplants in the past three years. Centers submit data at two levels: TED and CRF.
Participating Center
City
State
MUD
RELATED
AUTO
Birmingham
AL
CRF
CRF
CRF
Providence Hospital HPC Transplant Center
Mobile
AL
N/A
N/A
CRF
University of Arkansas for Medical Sciences
Little Rock
AR
CRF
TED
N/A
Gilbert
AZ
CRF
CRF
CRF
Phoenix
AZ
CRF
CRF
CRF
Phoenix
AZ
CRF
CRF
CRF
Scottsdale
AZ
CRF
CRF
CRF
University Medical Center - Tucson
Tucson
AZ
CRF
TED
TED
City of Hope National Medical Center
Duarte
CA
CRF
TED
TED
La Jolla
CA
CRF
CRF
CRF
La Jolla
CA
CRF
CRF
CRF
Loma Linda University Cancer Center
Loma Linda
CA
CRF
CRF
CRF
Cedars Sinai Medical Center
Los Angeles
CA
CRF
TED
N/A
Children's Hospital of Los Angeles
Los Angeles
CA
CRF
TED
TED
UCLA Center for Health Sciences
Los Angeles
CA
CRF
CRF
TED
USC BMT Program
Los Angeles
CA
CRF
CRF
CRF
Children's Hospital of Oakland
Oakland
CA
CRF
CRF
CRF
Children's Hospital of Orange County
Orange
CA
CRF
CRF
CRF
University of Alabama Birmingham
Banner MD Anderson Cancer Center
Banner Blood and Marrow Transplant
Program
Mayo Clinic Arizona and Phoenix Children's
Hospital
Cancer Transplant Institute at Virginia G.
Piper Cancer Center
Scripps Blood & Marrow Transplant
Program
University of California, San Diego Medical
Center
Page | 54
CIBMTR 2015 Annual Report
Participating Center
APPENDIX A1: US CENTERS
City
State
MUD
RELATED
AUTO
St Joseph’s Hospital Irvine
Orange
CA
N/A
N/A
CRF
University of California Irvine Medical
Center
Orange
CA
CRF
CRF
CRF
Palo Alto
CA
CRF
CRF
CRF
Sutter Cancer Center
Sacramento
CA
TED
TED
TED
University of California - Davis Cancer
Center
Sacramento
CA
CRF
TED
TED
San Diego
CA
CRF
CRF
CRF
San Francisco
CA
CRF
CRF
CRF
San Francisco
CA
CRF
CRF
CRF
Stanford Health Care
Stanford
CA
CRF
CRF
TED
Stanford University Medical Center
Stanford
CA
CRF
CRF
TED
The Children's Hospital of Denver
Aurora
CO
CRF
CRF
CRF
University of Colorado Hospital
Aurora
CO
CRF
TED
TED
Colorado Blood Cancer Institute
Denver
CO
CRF
TED
TED
University of Colorado Medical School
Denver
CO
N/A
N/A
N/A
University of Connecticut
Farmington
CT
N/A
N/A
N/A
Yale New Haven Hospital
New Haven
CT
CRF
CRF
CRF
Children's National Medical Center
Washington
DC
CRF
TED
TED
Medstar Georgetown University Hospital
Washington
DC
CRF
N/A
CRF
Newark
DE
CRF
CRF
CRF
Alfred I. duPont Hospital for Children
Wilmington
DE
CRF
CRF
CRF
Shands HealthCare & University of Florida
Gainesville
FL
CRF
CRF
CRF
Lucile Packard Children’s Hospital
Rady Children's Hospital San Diego
University of California - San Francisco Adults
University of California - San Francisco Pediatrics
Christiana Care
Page | 55
CIBMTR 2015 Annual Report
Participating Center
APPENDIX A1: US CENTERS
City
State
MUD
RELATED
AUTO
BMT Program of Mayo Clinic / Nemours
and Wolfson Children's Hospital
Jacksonville
FL
CRF
CRF
CRF
Mayo Clinic Florida - Jacksonville
Jacksonville
FL
CRF
CRF
CRF
Miami Children's Hospital
Miami
FL
CRF
TED
TED
University of Miami - Adults
Miami
FL
CRF
CRF
CRF
Miami
FL
CRF
TED
TED
Orlando
FL
CRF
CRF
CRF
Pembroke
Pines
FL
TED
TED
TED
St. Petersburg
FL
CRF
CRF
CRF
H Lee Moffitt Cancer Center
Tampa
FL
CRF
TED
TED
Children's Healthcare of Atlanta at Egleston
Atlanta
GA
CRF
CRF
CRF
Emory University
Atlanta
GA
CRF
CRF
CRF
The Blood and Marrow Transplant Program
at Northside Hospital
Atlanta
GA
CRF
CRF
CRF
Georgia Regents University Cancer Center
Augusta
GA
CRF
CRF
CRF
Hawaii Medical Center
Honolulu
HI
N/A
N/A
N/A
Kapi'olani Medical Center for Women and
Children
Honolulu
HI
CRF
CRF
CRF
University of Iowa Hospital & Clinics
Iowa City
IA
CRF
CRF
CRF
St. Luke's Mountain States Tumor Institute
Boise
ID
N/A
N/A
CRF
Ann & Robert H. Lurie Children's Hospital
of Chicago
Chicago
IL
CRF
CRF
CRF
Northwestern Memorial Hospital
Chicago
IL
CRF
CRF
TED
Chicago
IL
CRF
TED
N/A
Chicago
IL
CRF
CRF
CRF
University of Miami / Jackson Memorial
Hospital
Blood & Marrow Transplant Center, Florida
Hospital Medical Group
Memorial Cancer Institute
All Children's Hospital
Northwestern Memorial Hospital Department of Immunotherapy
The Coleman Foundation Blood and
Marrow Transplant Center, Rush University
Page | 56
CIBMTR 2015 Annual Report
Participating Center
APPENDIX A1: US CENTERS
City
State
MUD
RELATED
AUTO
University of Chicago Medical Center
Chicago
IL
CRF
CRF
CRF
University of Illinois at Chicago Medical
Center
Chicago
IL
CRF
CRF
CRF
Loyola University Medical Center
Maywood
IL
CRF
CRF
CRF
Advocate Lutheran General Hospital
Park Ridge
IL
N/A
TED
TED
Zion
IL
CRF
CRF
CRF
Indiana Blood & Marrow Transplantation
Beech Grove
IN
CRF
CRF
CRF
Indiana University Hospital / Riley Hospital
for Children
Indianapolis
IN
CRF
CRF
TED
St Vincent Hospital Indianapolis
Indianapolis
IN
N/A
CRF
CRF
University of Kansas
Kansas City
KS
CRF
CRF
CRF
Wichita
KS
N/A
CRF
CRF
Lexington
KY
CRF
TED
TED
Louisville
KY
CRF
TED
TED
New Orleans
LA
CRF
CRF
CRF
Ochsner Medical Center
New Orleans
LA
N/A
CRF
TED
Tulane University Medical Center
New Orleans
LA
CRF
CRF
CRF
Shreveport
LA
CRF
CRF
CRF
Beth Israel Deaconess Medical Center
Boston
MA
CRF
TED
TED
Boston Medical Center
Boston
MA
N/A
N/A
TED
Boston
MA
CRF
CRF
TED
Boston
MA
CRF
TED
TED
Boston
MA
CRF
TED
TED
Cancer Treatment Centers of America Midwest
Via Christi Hospitals Wichita
University of Kentucky Medical Center
University of Louisville Hospital / James
Brown Cancer Center
Louisiana State University Children's
Hospital
Louisiana State University Health Sciences
Center - Shreveport
Dana Farber Cancer Institute at Brigham
and Women's Hospital - Adults
Dana Farber Cancer Institute at Brigham
and Women's Hospital - Pediatrics
Massachusetts General Hospital
Page | 57
CIBMTR 2015 Annual Report
Participating Center
APPENDIX A1: US CENTERS
City
State
MUD
RELATED
AUTO
Boston
MA
CRF
TED
TED
Lahey Clinic Medical Center
Burlington
MA
N/A
N/A
TED
UMass Memorial Medical Center
Worcester
MA
CRF
CRF
CRF
Johns Hopkins Oncology Center
Baltimore
MD
TED
TED
TED
University of Maryland School of Medicine
Baltimore
MD
CRF
CRF
CRF
National Heart Lung & Blood Institute
Bethesda
MD
N/A
TED
N/A
National Institutes of Allergy & Infectious
Disease
Bethesda
MD
N/A
TED
N/A
National Institutes of Health
Bethesda
MD
N/A
TED
N/A
Bethesda
MD
N/A
CRF
CRF
Bethesda
MD
CRF
N/A
N/A
Ann Arbor
MI
CRF
TED
TED
Children's Hospital of Michigan
Detroit
MI
CRF
CRF
CRF
Henry Ford Hospital Bone Marrow
Transplant Program
Detroit
MI
CRF
CRF
CRF
Karmanos Cancer Institute
Detroit
MI
CRF
CRF
CRF
Helen DeVos Children's Hospital
Grand Rapids
MI
CRF
CRF
CRF
Spectrum Health
Grand Rapids
MI
CRF
CRF
CRF
Abbott Northwest Hospital
Minneapolis
MN
N/A
N/A
TED
Masonic Cancer Center University of
Minnesota
Minneapolis
MN
CRF
CRF
CRF
Mayo Clinic Rochester
Rochester
MN
CRF
CRF
CRF
Saint Luke’s Blood & Marrow Transplant
Program
Kansas City
MO
CRF
CRF
CRF
Tufts New England Medical Center
NIH - NCI Experimental Transplantation
and Immunology Branch (Related Donor
Program)
NIH - NCI Matched Unrelated Donor
Program
The University of Michigan
Page | 58
CIBMTR 2015 Annual Report
Participating Center
APPENDIX A1: US CENTERS
City
State
MUD
RELATED
AUTO
Kansas City
MO
CRF
CRF
CRF
Cardinal Glennon Children's Hospital
St. Louis
MO
CRF
CRF
CRF
SSM Health Saint Louis University Hospital
St. Louis
MO
CRF
TED
TED
Washington University School of Medicine
St. Louis
MO
CRF
CRF
TED
St. Louis
MO
CRF
CRF
CRF
Jackson
MS
CRF
TED
TED
Billings
MT
N/A
N/A
TED
Chapel Hill
NC
CRF
CRF
CRF
Charlotte
NC
CRF
CRF
CRF
Levine Cancer Institute
Charlotte
NC
N/A
CRF
CRF
Duke University - Adults
Durham
NC
CRF
TED
TED
Durham
NC
CRF
CRF
CRF
Durham
NC
N/A
TED
N/A
NC
N/A
N/A
N/A
NC
CRF
TED
TED
The Children's Mercy Hospitals and Clinics
Washington University / St Louis Children's
Hospital
University of Mississippi Medical Center Jackson
Billings Clinic Cancer Center
University of North Carolina Hospitals Chapel Hill
BMT Program at Levine Children's Hospital
/ Carolinas Medical Center
Duke University Medical Center, Pediatric
BMT
Duke University, Immunology / BMT,
Pediatrics
Novant Health Oncology Specialists
Wake Forest Baptist Health
WinstonSalem
WinstonSalem
CHI Health Bergan Mercy
Omaha
NE
N/A
N/A
TED
CHI Health Immanuel
Omaha
NE
N/A
N/A
TED
Nebraska Methodist Hospital
Omaha
NE
N/A
N/A
TED
University of Nebraska Medical Center
Omaha
NE
CRF
CRF
CRF
Dartmouth-Hitchcock Medical Center
Lebanon
NH
CRF
CRF
CRF
Hackensack University Medical Center
Hackensack
NJ
CRF
CRF
CRF
Page | 59
CIBMTR 2015 Annual Report
Participating Center
APPENDIX A1: US CENTERS
City
State
MUD
RELATED
AUTO
New
Brunswick
NJ
CRF
CRF
CRF
Albuquerque
NM
N/A
N/A
CRF
Childrens Hospital at Montefiore
Bronx
NY
CRF
TED
TED
Montefiore Medical Center
Bronx
NY
CRF
CRF
TED
Roswell Park Cancer Institute
Buffalo
NY
CRF
CRF
CRF
Westchester Medical Center
Hawthorne
NY
CRF
CRF
CRF
North Shore University Hospital
Manhasset
NY
CRF
TED
TED
Cohen Children's Medical Center of New
York
Memorial Sloan Kettering Cancer Center Adults
Memorial Sloan Kettering Cancer Center Pediatrics
Morgan Stanley Children's Hospital of New
York
New Hyde
Park
NY
CRF
CRF
CRF
New York
NY
CRF
TED
TED
New York
NY
CRF
TED
TED
New York
NY
CRF
CRF
CRF
Mount Sinai Medical Center - New York
New York
NY
CRF
CRF
TED
New York Presbyterian Hospital
New York
NY
CRF
CRF
CRF
New York Presbyterian Hospital / Columbia
University Medical Center
New York
NY
CRF
CRF
CRF
New York University Medical Center
New York
NY
TED
TED
TED
St Vincent's Hospital Manhattan
New York
NY
N/A
TED
TED
University of Rochester Medical Center
Rochester
NY
CRF
CRF
CRF
Stony Brook University Medical Center
Stony Brook
NY
TED
TED
CRF
State University of NY Upstate Medical
University
Syracuse
NY
N/A
CRF
CRF
Akron
OH
CRF
CRF
CRF
Cincinnati
OH
CRF
CRF
CRF
Cancer Institute of New Jersey
University of New Mexico - Pediatrics
Akron Children's Hospital
Cincinnati Children's Hospital
Page | 60
CIBMTR 2015 Annual Report
Participating Center
APPENDIX A1: US CENTERS
City
State
MUD
RELATED
AUTO
Jewish Hospital Blood and Marrow
Transplant Center
Cincinnati
OH
CRF
CRF
CRF
University of Cincinnati Medical Center
Cincinnati
OH
CRF
CRF
CRF
Cleveland Clinic
Cleveland
OH
CRF
CRF
CRF
Seidman Cancer Center - University
Hospitals Case Medical Center
Cleveland
OH
CRF
CRF
CRF
Nationwide Children's Hospital
Columbus
OH
CRF
CRF
CRF
The Ohio State University Medical Center
Columbus
OH
CRF
CRF
CRF
Miami Valley Hospital BMT Program
Dayton
OH
N/A
N/A
CRF
Oklahoma University Medical Center
Oklahoma
City
OK
CRF
CRF
CRF
Cancer Treatment Centers of America
Tulsa
OK
CRF
CRF
CRF
Saint Francis Hospital - Oklahoma
Tulsa
OK
N/A
TED
TED
Legacy Good Samaritan Hospital and
Medical Center
Portland
OR
N/A
N/A
CRF
Oregon Health and Science University
Portland
OR
CRF
CRF
CRF
Pediatric BMT Program, Doernbecher
Children's Hospital (OHSU)
Portland
OR
CRF
CRF
CRF
Providence Portland Medical Center
Portland
OR
N/A
N/A
CRF
Geisinger Medical Center
Danville
PA
CRF
TED
TED
Penn State Hershey Medical Center
Hershey
PA
CRF
CRF
CRF
Abramson Cancer Center University Pennsylvania Medical Center
Philadelphia
PA
CRF
CRF
CRF
Eastern Regional Medical Center
Philadelphia
PA
N/A
CRF
CRF
Hahnemann University Hospitals
Philadelphia
PA
CRF
TED
TED
Philadelphia Children's Hospital
Philadelphia
PA
TED
TED
N/A
St Christopher's Hospital for Children
Philadelphia
PA
TED
TED
TED
Page | 61
CIBMTR 2015 Annual Report
Participating Center
APPENDIX A1: US CENTERS
City
State
MUD
RELATED
AUTO
Temple Bone Marrow Transplant Program
Philadelphia
PA
CRF
TED
TED
Thomas Jefferson University
Philadelphia
PA
TED
TED
TED
Children's Hospital of Pittsburgh of UPMC
Pittsburgh
PA
CRF
CRF
CRF
University of Pittsburgh Medical Center
Pittsburgh
PA
CRF
CRF
CRF
West Penn Hospital
Pittsburgh
PA
CRF
CRF
CRF
Roger Williams Medical Center
Providence
RI
CRF
TED
TED
Charleston Hematology Oncology
Charleston
SC
N/A
CRF
CRF
Medical University of South Carolina
Charleston
SC
CRF
TED
TED
Richland Memorial Hospital
Columbia
SC
N/A
N/A
N/A
Cancer Centers of the Carolinas
Greenville
SC
CRF
CRF
CRF
Saint Francis Hospital - Greenville
Greenville
SC
N/A
CRF
CRF
Avera Mckennan Transplant Institute
Sioux Falls
SD
CRF
CRF
CRF
Thompson Cancer Survival Center
Knoxville
TN
N/A
N/A
TED
Baptist Blood and Marrow Transplant
Memphis
TN
CRF
CRF
CRF
Baptist Centers for Cancer Care
Memphis
TN
TED
TED
TED
St Jude Children's Research Hospital
Memphis
TN
CRF
TED
N/A
The West Clinic / Methodist Healthcare
Blood and Marrow Transplant Center
Memphis
TN
N/A
N/A
TED
University of Tennessee
Memphis
TN
CRF
CRF
CRF
Sarah Cannon BMT Center at Centennial
Medical Center
Nashville
TN
CRF
TED
TED
Vanderbilt University
Nashville
TN
CRF
TED
TED
Vanderbilt University Veterans Center
Nashville
TN
TED
TED
N/A
Page | 62
CIBMTR 2015 Annual Report
Participating Center
APPENDIX A1: US CENTERS
City
State
MUD
RELATED
AUTO
Amarillo
TX
CRF
TED
TED
Southwest Regional Cancer Center
Austin
TX
N/A
N/A
N/A
Baylor University Medical Center
Dallas
TX
CRF
CRF
CRF
Children's Medical Center - Dallas
Dallas
TX
CRF
CRF
CRF
Medical City Dallas Hospital
Dallas
TX
CRF
CRF
CRF
UT Southwestern Medical Center - BMT
Program
Dallas
TX
CRF
CRF
CRF
Fort Worth
TX
CRF
CRF
CRF
Baylor College of Medicine
Houston
TX
CRF
CRF
CRF
MD Anderson Cancer Center
Houston
TX
CRF
CRF
N/A
Wilford Hall Medical Center
Lackland AFB
TX
TED
TED
TED
Covenant Health System Hematopoietic
Transplant Program
Lubbock
TX
N/A
TED
TED
Texas Tech University Medical Center
Lubbock
TX
CRF
CRF
CRF
South Texas Veterans Health Care System
San Antonio
TX
N/A
CRF
CRF
Texas Transplant Institute
San Antonio
TX
CRF
CRF
CRF
University of Texas Health Science Center
San Antonio
TX
N/A
CRF
CRF
Temple
TX
N/A
N/A
CRF
Latter Day Saints Hospital
Salt Lake City
UT
CRF
CRF
CRF
University of Utah Medical Center
Salt Lake City
UT
CRF
CRF
CRF
Salt Lake City
UT
CRF
CRF
CRF
Salt Lake City
UT
CRF
CRF
CRF
Charlottesville
VA
CRF
CRF
CRF
Texas Oncology
Cook Children's Medical Center
Scott and White Memorial Hospital
Utah Blood and Marrow Transplant
Program - Adults
Utah Blood and Marrow Transplant
Program - Pediatrics
University of Virginia Health System
Page | 63
CIBMTR 2015 Annual Report
Participating Center
APPENDIX A1: US CENTERS
City
State
MUD
RELATED
AUTO
Fairfax - Northern Virginia Hospital
Fairfax
VA
CRF
CRF
CRF
Virginia Oncology Associates
Norfolk
VA
N/A
N/A
TED
Virginia Commonwealth University Massey
Cancer Center BMT Program
Richmond
VA
CRF
CRF
CRF
University of Vermont Cancer Center
Burlington
VT
N/A
N/A
TED
Fred Hutchinson Cancer Center
Seattle
WA
CRF
CRF
CRF
VA Puget Sound Healthcare System
Seattle
WA
TED
TED
N/A
Madison
WI
CRF
CRF
CRF
Marshfield Clinic
Marshfield
WI
N/A
N/A
CRF
Aurora St Luke's Medical Center
Milwaukee
WI
N/A
N/A
CRF
Children's Hospital of Wisconsin
Milwaukee
WI
CRF
CRF
CRF
Froedtert & Medical College of Wisconsin
Milwaukee
WI
CRF
CRF
TED
Morgantown
WV
CRF
CRF
CRF
University of Wisconsin Hospital and Clinics
Osborn Hematopoietic Malignancy &
Transplantation Program
Page | 64
CIBMTR 2015 Annual Report
APPENDIX A2: INTERNATIONAL CENTERS
APPENDIX A2: INTERNATIONAL CENTERS
The following table lists the international transplant centers that submited data to the CIBMTR
Research Database for matched unrelated donor (MUD) allogeneic, related donor allogeneic, and
autologous transplants in the past three years. Centers submit data at two levels: TED and CRF.
Participating Center
City
Country
MUD
RELATED
AUTO
Fundaleu-Angelica Ocampo
Buenos Aires
Argentina
CRF
CRF
CRF
Hospital Universitario Austral
Buenos Aires
Argentina
CRF
CRF
CRF
Hospital Privado de Cordoba
Cordoba
Argentina
CRF
CRF
CRF
Royal Adelaide Hospital / SA
Pathology
Adelaide
Australia
CRF
CRF
N/A
Royal Prince Alfred Hospital
Camperdown
Australia
CRF
CRF
TED
St Vincent's Hospital
Darlinghurst
Australia
TED
TED
N/A
Herston
Australia
CRF
CRF
CRF
Melbourne
Australia
TED
TED
TED
Parkville
Australia
CRF
CRF
N/A
Fiona Stanley Hospital
Perth
Australia
CRF
CRF
N/A
Princess Margaret Hospital for
Children
Perth
Australia
CRF
CRF
TED
Royal Perth Hospital
Perth
Australia
CRF
CRF
N/A
Sydney Children's Hospital
Randwick
Australia
CRF
CRF
N/A
Lady Cilento Children’s Hospital
South
Brisbane
Australia
N/A
CRF
CRF
Royal Melbourne Hospital
Victoria
Australia
CRF
CRF
N/A
Calvary Mater Newcastle Hospital
Waratah
Australia
N/A
N/A
CRF
Children's Hospital at Westmead
Westmead
Australia
CRF
CRF
TED
Westmead Hospital
Westmead
Australia
CRF
CRF
N/A
Royal Brisbane & Women's Hospital
Alfred Hospital
Royal Children's Hospital
Page | 65
CIBMTR 2015 Annual Report
Participating Center
APPENDIX A2: INTERNATIONAL CENTERS
City
Country
MUD
RELATED
AUTO
Vienna
Austria
TED
TED
N/A
Children's University Hospital
Bruxelles
Belgium
TED
TED
TED
University Hospital Antwerp
Edegem
Belgium
TED
TED
N/A
University Hospital Gasthuisberg
Leuven
Belgium
TED
TED
N/A
University Estadual de Campinas
Campinas
Brazil
CRF
CRF
CRF
Curitiba
Brazil
CRF
CRF
CRF
Hospital Amaral Carvalho
Jau
Brazil
CRF
CRF
CRF
Hospital de Porto Alegre
Porto Alegre
Brazil
TED
TED
TED
Rio de
Janeiro
Brazil
CRF
CRF
CRF
Albert Einstein Hospital
Sao Paolo
Brazil
TED
TED
TED
Hospital Sirio Libanes
Sao Paolo
Brazil
CRF
CRF
CRF
Instituto de Oncologia Pediatrica
Sao Paolo
Brazil
TED
TED
TED
Alberta Children's Hospital
Calgary
Canada
CRF
CRF
CRF
Tom Baker Cancer Centre
Calgary
Canada
TED
TED
TED
Queen Elizabeth II Health Sciences
Center
Halifax
Canada
TED
TED
TED
Hamilton Health Sciences
Hamilton
Canada
CRF
CRF
CRF
Kingston General Hospital
Kingston
Canada
N/A
N/A
TED
Centre Hospitalier
Montreal
Canada
CRF
CRF
CRF
Maisonneuve - Rosemont Hospital
Montreal
Canada
TED
TED
N/A
McGill University Health Centre Royal Victoria Hospital
Montreal
Canada
TED
TED
N/A
Montreal Children's Hospital
Montreal
Canada
TED
TED
TED
St Anna Children's Hospital
Hospital de Clinicas Curitiba
Instituto Nacional de Cancer
Page | 66
CIBMTR 2015 Annual Report
Participating Center
APPENDIX A2: INTERNATIONAL CENTERS
City
Country
MUD
RELATED
AUTO
Quebec
Canada
TED
TED
TED
Quebec City
Canada
TED
TED
TED
Saint John Regional Hospital
Saint John
Canada
N/A
N/A
CRF
St John's Health Sciences Center
St. John's
Canada
N/A
N/A
TED
Health Sciences North
Sudbury
Canada
N/A
N/A
TED
Princess Margaret Hospital (alloHCT)
Toronto
Canada
CRF
CRF
N/A
Princess Margaret Hospital (autoHCT)
Toronto
Canada
N/A
N/A
CRF
British Columbia Children's Hospital
Vancouver
Canada
CRF
CRF
CRF
Vancouver General Hospital
Vancouver
Canada
N/A
N/A
N/A
Winnipeg
Canada
CRF
CRF
CRF
Barranquilla
Colombia
TED
TED
TED
Clinica de Marly
Bogota
Colombia
CRF
CRF
CRF
Charles University Hospital - Pilsen
Pilsen
CRF
CRF
CRF
Institute of Hem-Blood Transfusion
Praha
TED
TED
N/A
University Hospital, Rigshospitalet
Copenhagen
Denmark
CRF
CRF
N/A
Children's Cancer Hospital - Egypt
Cairo
Egypt
N/A
TED
TED
NCI Cairo University
Cairo
Egypt
TED
TED
N/A
Helsinki
Finland
CRF
CRF
N/A
Turku University
Turku
Finland
TED
TED
N/A
Centre Hospitalier Regional University
D'Angers
Angers
France
TED
TED
N/A
Besançon
France
CRF
CRF
N/A
Hotel-Dieu de Quebec
CHA-Enfant-Jesus Hospital
CancerCare Manitoba / University of
Manitoba
Instituto de Trasplante de Medula
Osea de la Costa Caribe
Helsinki University Central Hospital
Hopital Jean Minjoz
Czech
Republic
Czech
Republic
Page | 67
CIBMTR 2015 Annual Report
APPENDIX A2: INTERNATIONAL CENTERS
Participating Center
City
Country
MUD
RELATED
AUTO
Hopital Claude Huriez, Lille
Lille
France
MED-A
MED-A
N/A
Hospital Edouard Herriot
Lyon
France
MED-A
MED-A
N/A
Institute Paoli Calmettes
Marseille
France
CRF
CRF
N/A
Paris
France
CRF
CRF
N/A
Poitiers
France
CRF
CRF
N/A
Essen
Germany
CRF
CRF
CRF
University Children’s Hospital
Frankfurt
Frankfurt
Germany
CRF
CRF
CRF
Albert-Ludwig University - Freiburg
Freiburg
Germany
CRF
CRF
N/A
UKE Hamburg, Klinik und Poliklinik für
Stammzelltransplantation
Hamburg
Germany
CRF
CRF
N/A
Heidelberg
Germany
CRF
CRF
N/A
Christian Albrechts University
Kiel
Germany
CRF
CRF
CRF
University Leipzig, BMT Center
Leipzig
Germany
CRF
N/A
N/A
University Hospital Mainz
Mainz
Germany
TED
TED
TED
Munich
Germany
CRF
CRF
N/A
Regensburg
Germany
MED-A
MED-A
N/A
UniversitÓ“ts Klinikum Tubingen
Tübingen
Germany
CRF
TED
N/A
UniversitÓ“ts Kinderklinik Tubingen
Tübingen
Germany
CRF
TED
N/A
Ulm
Germany
CRF
CRF
TED
Wiesbaden
Germany
CRF
CRF
N/A
Rio Patras
Greece
TED
TED
TED
Shatin
Hong Kong
CRF
CRF
N/A
Hospital Saint Louis
Hospital Jean Bernard
University Hospital of Essen
University of Heidelberg
University of Munich
Klinikum der UniversitÓ“t Regensburg
UniversitÓ“t Ulm - Adults
Deutsche Klinik für Diagnostik Wiesbaden
University Hospital of Patras, Patras
University Medical Center
Chinese University of Hong Kong
Page | 68
CIBMTR 2015 Annual Report
Participating Center
APPENDIX A2: INTERNATIONAL CENTERS
City
Country
MUD
RELATED
AUTO
Ahmedabad
India
CRF
CRF
CRF
Delhi
India
CRF
CRF
CRF
Gandhinagar
India
N/A
TED
TED
Gurgaon
India
N/A
CRF
CRF
Ludhiana
India
TED
TED
TED
New Delhi
India
CRF
CRF
CRF
Puducherry
India
N/A
TED
TED
Pune
India
CRF
CRF
CRF
Vellore
India
CRF
CRF
N/A
Haifa
Israel
CRF
CRF
CRF
Haddasah University Hospital
Jerusalem
Israel
CRF
CRF
N/A
Davidoff Cancer Center, Rabin
Medical Center, Beilinson Hospital
Petah Tikva
Israel
CRF
CRF
CRF
Tel-Aviv Sourasky Medical Center
Tel-Aviv
Israel
CRF
CRF
CRF
Israel
CRF
CRF
CRF
Israel
CRF
CRF
N/A
Gujrat Cancer & Research Institute
Sir Ganga Ram Hospital
Apollo Hospital International Ltd
Fortis Memorial Research Institute
Bone Marrow Transplant Unit,
Christian Medical College, Ludhiana
Rajiv Gandhi Cancer Institute and
Research Centre
Jawaharlal Institute of Postgraduate
Medical Education and Research
Sahyadri Speciality Hospital
Christian Medical College Hospital
Rambam Medical Center
Chaim Sheba Medical Center Pediatrics
Sheba Medical Center
TelHashomer
TelHashomer
Instituto di Ematologia e Oncologia
Medica Seragnoli
Bologna
Italy
MED-A
MED-A
N/A
University Bologna - Pediatrics
Bologna
Italy
TED
TED
TED
St Eugenio Hospital
Rome
Italy
CRF
CRF
N/A
Ospedale Molinette
Torino
Italy
MED-A
MED-A
N/A
University Torino
Torino
Italy
TED
TED
N/A
Osaka City University
Osaka
Japan
CRF
CRF
N/A
Page | 69
CIBMTR 2015 Annual Report
APPENDIX A2: INTERNATIONAL CENTERS
Participating Center
City
Country
MUD
RELATED
AUTO
Hospital Universitario
Monterrey
Mexico
CRF
CRF
CRF
Puebla
Mexico
TED
TED
TED
Academic Medical Center
Amsterdam
Netherlands
CRF
TED
TED
VU Medical Center - Amsterdam
Amsterdam
Netherlands
CRF
TED
TED
University Medical Center Groningen
Groningen
Netherlands
CRF
N/A
N/A
Leiden
Netherlands
CRF
TED
N/A
Academic Hospital Maastricht
Maastricht
Netherlands
CRF
TED
N/A
University Hospital of Nijmegen
Nijmegen
Netherlands
CRF
TED
N/A
Erasmus MC - Daniel den Hoed Cancer
Center
Rotterdam
Netherlands
CRF
TED
N/A
University Hospital Utrecht
Utrecht
Netherlands
CRF
N/A
N/A
University Medical Center Utrecht Pediatrics
Utrecht
Netherlands
CRF
N/A
N/A
Auckland City Hospital
Auckland
New Zealand
CRF
CRF
N/A
Starship Children's Hospital
Auckland
New Zealand
CRF
CRF
N/A
Christchurch
New Zealand
CRF
CRF
TED
Wellington Blood and Cancer Centre
Wellington
New Zealand
CRF
CRF
N/A
Rikshospitalet - The National Hospital
Oslo
Norway
CRF
N/A
N/A
Karachi
Pakistan
CRF
CRF
CRF
Rawalpindi
Pakistan
N/A
CRF
CRF
San Borja
Peru
N/A
TED
N/A
Katowice
Poland
CRF
CRF
N/A
Centro de Hematologia y Medicina
Interna Clinica RUIZ de Puebla
Leiden University Medical Center
Christchurch Hospital
Hill Park Hospital - National Institute
of Blood Diseases and Bone Marrow
Transplantation
Armed Forces Bone Marrow
Transplant Center
Instituto Nacional Salud Del Niño San
Borja
Silesian Medical Academy
Page | 70
CIBMTR 2015 Annual Report
Participating Center
APPENDIX A2: INTERNATIONAL CENTERS
City
Country
MUD
RELATED
AUTO
Poznan
Poland
MED-A
MED-A
N/A
Wroclaw
Poland
CRF
CRF
N/A
Lisbon
Portugal
CRF
CRF
N/A
Porto
Portugal
N/A
N/A
N/A
St.
Petersburg
Russian
Federation
TED
TED
TED
Riyadh
Saudi Arabia
CRF
CRF
N/A
Riyadh
Saudi Arabia
CRF
CRF
N/A
Singapore
Singapore
CRF
CRF
CRF
Singapore
Singapore
CRF
CRF
CRF
Parkway Cancer Centre
Singapore
Singapore
CRF
CRF
CRF
Singapore General Hospital
Singapore
Singapore
CRF
CRF
N/A
Slovak Medical University
Bratislava
Slovak
Republic
TED
TED
N/A
Constantiaberg Medi-Clinic
Cape Town
South Africa
CRF
CRF
CRF
University of Witwatersrand
Parktown
South Africa
CRF
CRF
CRF
Asan Medical Center
Seoul
South Korea
CRF
CRF
N/A
Samsung Medical Center
Seoul
South Korea
CRF
CRF
CRF
Seoul St. Mary's Hospital Catholic
BMT Center
Seoul
South Korea
CRF
CRF
CRF
Barcelona
Spain
TED
TED
N/A
Gregorio Maranon University General
Hospital
Madrid
Spain
CRF
CRF
CRF
Hospital Puerta Hierro
Madrid
Spain
MED-A
MED-A
N/A
Poznan University of Medical Sciences
Lower-Silesian Center for Cellular
Transplantation and National Bone
Marrow Donor Registry
Institute Portugues de Oncologia Lisbon
Institute Portugues de Oncologia Porto
St Petersburg State Medical University
King Faisal Specialist Hospital Pediatrics
King Faisal Specialist Hospital &
Research Center - Adults
National University Health System Adults
National University Health System Pediatrics
University Barcelona
Page | 71
CIBMTR 2015 Annual Report
Participating Center
APPENDIX A2: INTERNATIONAL CENTERS
City
Country
MUD
RELATED
AUTO
Santander
Spain
TED
TED
TED
Valencia
Spain
CRF
CRF
N/A
Gothenborg
Sweden
CRF
CRF
N/A
Lund
Sweden
MED-A
MED-A
N/A
Stockholm
Sweden
CRF
CRF
N/A
Uppsala
Sweden
CRF
CRF
N/A
Basel Kantonsspital
Basel
Switzerland
CRF
CRF
N/A
University Hospital-Zurich
Zurich
Switzerland
MED-A
MED-A
N/A
Chang Gung Children's Hospital
Taoyuan
Taiwan
CRF
CRF
CRF
King Chulalongkorn Memorial
Hospital
Bangkok
Thailand
TED
TED
TED
Ankara University Faculty of Medicine
Ankara
Turkey
TED
TED
N/A
Gulhane Military Medical Academy
Ankara
Turkey
CRF
CRF
CRF
Medical Park Hospital - Antalya
Istanbul
Turkey
CRF
CRF
CRF
Birmingham Children's Hospital
Birmingham
TED
TED
N/A
Queen Elizabeth Hospital Birmingham
Birmingham
CRF
CRF
N/A
Bristol Children's Hospital
Bristol
CRF
CRF
N/A
Addenbrooke's NHS Trust
Cambridge
CRF
CRF
N/A
MED-A
MED-A
N/A
CRF
CRF
N/A
CRF
CRF
N/A
Hospital Universitario Marques de
Valdecilla
Hospital Universitario La Fe
Sahlgrenska University Hospital
University Hospital of Lund
Karolinska University Hospital, Centre
for Allogeneic Stem Cell
Transplantation
University Hospital - Uppsala
Beatson West of Scotland Cancer
Centre
Glasgow
Royal Hospital for Sick Children
Glasgow
Imperial College / Hammersmith
Hospital
London
United
Kingdom
United
Kingdom
United
Kingdom
United
Kingdom
United
Kingdom
United
Kingdom
United
Kingdom
Page | 72
CIBMTR 2015 Annual Report
Participating Center
APPENDIX A2: INTERNATIONAL CENTERS
City
Imperial College - St Mary's Hospital
London
The Royal Free Hampstead NHS Trust
London
Royal Marsden Hospital
Sutton
Country
MUD
RELATED
AUTO
United
Kingdom
United
Kingdom
United
Kingdom
CRF
CRF
N/A
MED-A
MED-A
N/A
N/A
N/A
N/A
British Hospital
Montevideo
Uruguay
CRF
CRF
CRF
Centro de Trasplante del Servicio
Medico Integral (SMI)
Montevideo
Uruguay
CRF
CRF
CRF
Hospital Maciel
Montevideo
Uruguay
CRF
CRF
CRF
Valencia
Venezuela
TED
TED
TED
Ciudad Hospitalaraia Dr Enrique
Tejera
Page | 73
CIBMTR 2015 Annual Report
APPENDIX B: COORDINATING CENTER
ORGANIZATIONAL STRUCTURE AND PERSONNEL
APPENDIX B: COORDINATING CENTER ORGANIZATIONAL
STRUCTURE AND LEADERSHIP
The CIBMTR Coordinating Center resides on two campuses: one is located at MCW in Milwaukee, WI,
and the other is located at NMDP/Be The Match in Minneapolis, MN. The Coordinating Center
provides administrative, statistical, data management, clinical trials, IT, and personnel support for
CIBMTR activities, and it benefits from a unique, collegial partnership with the Division of Biostatistics
of MCW.
CIBMTR Milwaukee has approximately 70 employees and is an academic division of the MCW
Department of Medicine. The Milwaukee office receives administrative support from the MCW
departments of Grants and Contracts, Development, Office of Technology Development, Public
Affairs, Human Resources and the Department of Medicine Administration. CIBMTR Minneapolis has
approximately 120 employees, and several NMDP/Be The Match departments provide support for
CIBMTR activities, including Finance, Contracts, and Marketing & Communications.
Page | 74
CIBMTR 2015 Annual Report
APPENDIX B: ORGANIZATIONAL STRUCTURE – MILWAUKEE CAMPUS
APPENDIX B1: ORGANIZATIONAL STRUCTURE – MILWAUKEE CAMPUS
Chief Scientific Director
M Horowitz, MD, MS
Administrator
Medical Faculty
CIBMTR Milwaukee
P Steinert, PhD, MBA
Program Director,
Data Operations
J Brunner-Grady, PA-C
Grants and
Contracts
Financial
Manager
C Gonzalez
Program
Manager,
SCTOD
C Doleysh
Meetings
Program
Manager
D Waldoch
Snyder
1
Program
Manager,
Business
Office
P Vespalec
Program
Coordinator II
R Dunn
Administrative
Assistant, Sr
K Jackson
Administrative
Assistant
DL Campbell
J Claas
University of Minnesota
NMDP/Be The Match
3
Fred Hutchinson Cancer Research Center
4
University of North Carolina
2
Study Clinical
Research
Coordinator
S Kulkarni
Clinical
Research
Assistant III
C Abel
Clinical
Research
Assistant II
M Patel
Data Entry
A Pereles
Program Director,
Advancement
S Fisher
Manager,
Data
Operations
S Meiers
Program
Coordinator II
K Bhavsar
Clinical Research
Coordinator II
A Prentice
T Hunt
Program
Coordinator I
A Pope
Clinical Research
Coordinator I
A Benoit
Program Director,
Statistics & Clinical
Outcomes Research
W Pérez, MPH
Medical Writer
J Gillis-Smith
Program
Coordinator II
M Brey
M Simaytis
Communications
Specialist
V Vlach
Senior
Biostatistician
J Carreras
M Chen
H Wang
Biostatistician
K Bo-Subait
A DiGilio
M Fei
N He
M Hemmer
K Hu
J Huang
H Millard
A St. Martin
X Zhu
Program
Coordinator I
M Geronime
Director, IT
E Bergman, MBA, MS
Program/IS
Manager
T Moerke
Bus Systems
Analyst Assoc
TBD
Information
Security
Analyst
J Rineck
Desktop
Support
Technician
V Buendia
Database
Administrator
B Liu
Programmer
Analyst IV
H Tian
Programmer
Analyst III
P Gengler
J Gier
Database Analyst III
X Zhang
Programmer
Analyst II
T Graczkowski
Database Analyst I
M Desai
Metadata Analyst
A Kummerow
Manager IS I
(part time)
C Zhang
Senior Research
Advisor
D Weisdorf, MD1
Senior Scientific
Director
L Burns, MD2
M Eapen, MD, MS
S Lee, MD, MPH3
M Pasquini, MD, MS
JD Rizzo, MD, MS
B Shaw, MD, PhD
Scientific Director
M Arora, MD,MS1
A D’Souza, MBBS, MD
M Hamadani, MD
P Hari, MD, MS
M Riches, MD, MS4
W Saber, MD, MS
E Thiel, MD, MS
Page | 75
CIBMTR 2015 Annual Report
APPENDIX B2: ORGANIZATIONAL STRUCTURE – MINNEAPOLIS CAMPUS
APPENDIX B2: ORGANIZATIONAL STRUCTURE – MINNEAPOLIS CAMPUS (PART 1)
Chief Scientific Director
Mary M Horowitz, MD, MS
Associate Scientific Director
D Confer, MD
Vice President, CIBMTR Minneapolis
R King, MPH
Director, CIBMTR IT Systems
M Prestegaard
Senior Manager,
Program Management
K Gee
Project Manager
S Freeman
K O’Connor
A Pull
B Wakaruk
Project Coordinator
DM Campbell
Principal Business
Systems Analyst
E Narr
Senior Business
Systems Analyst
S Ewer
Business Systems
Analyst
D Kloker
Solutions Manager
E Chan
Senior System
Administrator
C Yang
Business Intelligence
Solutions Architect
TBD
Principal Software
Engineer
C Giddegowda
Senior Software
Engineer
A Gomez
N Hood
J Smith
Software Engineer
Z Ahmed
C Jordahl
G Ogega
Software Engineer ETL
N Aryal
S Stagg
Associate System
Administrator
A Westin
Director,
Bioinformatics
M Maiers, MS1
Director, Immunobiology
and Observational Research
S Spellman, MBS1
Data Solutions
Manager
R Renner
Quality Assurance
Manager
V Yarra
Senior Metadata
Analyst
W Zhang
Metadata Analyst
M Nych
S Sorensen
Senior Data
Analyst
D McDonell
K Schaper
T Wirth
Senior Quality
Assurance
Analyst
B Samba
Quality
Assurance
Analyst
V Murukurthy
J Oakes
Principal Data
Architect
E Zink
Business Architect
B Burgess
Senior
Biostatistician
P Chitphakdiathai
M Haagenson
Biostatistician
D Kiefer
S Rouse
Project Coordinator
H Severance
Administrative
Specialist
A Carlson
Senior
Bioinformatics
Scientists
A Madbouly
E Williams
Bioinformatics
Scientists
S Fingerson
M Halagan
D Roe
Principal
Immunobiology
Research Scientist
A Howard
C Vierra-Green
Senior
Immunobiology
Research Scientist
M Brown
Immunobiology
Research Scientist
C Brady
D Scheller
S Waldvogel
Associate
Immunobiology
Research Scientist
A Spahn
1
Also serves as Scientific Director
Page | 76
CIBMTR 2015 Annual Report
APPENDIX B2: ORGANIZATIONAL STRUCTURE – MINNEAPOLIS CAMPUS
APPENDIX B2: ORGANIZATIONAL STRUCTURE – MINNEAPOLIS CAMPUS (PART 2)
Chief Scientific Director
Mary M Horowitz, MD, MS
Associate Scientific Director
D Confer, MD
Vice President, CIBMTR Minneapolis
R King, MPH
Senior Manager,
Monitoring & Auditing
D Christianson
Survey Research
Group
Supervisor
D Mattila
BMT CTN
Project
Manager
A Foley
Senior Human
Research
Protection
Specialist - IRB
T Rouse
Senior Human
Research
Protection
Specialist
C Jobe
Human
Research
Protection
Specialist
J Tkachenko
Administrative
Specialist
M Young
Senior Manager,
Prospective Research
R Drexler
Senior Clinical
Research
Associate
W Affield
A Birch
M Petcoff
L Wendland
Clinical Research
Associate
A Hendrickson
K Kane
C Newcomb
K Phalen
M Proue
K Reilly
Clinical Research
Specialist
E Eich
Audit Coordinator
E Nordquist
Research
Interviewer
C Griffith
C Jacox
C Kunakom
S Lease
TBD
Survey
Research
Assistant
E Michem
Senior Clinical
Research Specialist
A Adams
S Flesch
C Johnson
H Kobusingye
Clinical Research
Specialist
R Besser
C Petroske
J Vogel
Clinical Research
Assistant
TBD
Prospective
Research
Coordinator
J Dworski
Senior Manager, Data Management
M Matlack
Supervisor,
Clinical Research,
Recipient Data
Management
K Gardner
Supervisor, Quality
Control
B Levesque
Supervisor, Clinical
Research,
Donor Data
Management
A Hauck
Clinical Research
Coordinator III
E Johnson
Clinical Research
Coordinator II
A Draxler
A Mitsch
A Mussetter
K Nutter
C Olson
T Thole
Clinical Research
Coordinator I
E Mitchem
P Wallace
Quality Control
Specialist
K Kutzner
Data Entry
Coordinator II
L Horne
Data Entry
Coordinator I
P Lee
K Xong
Imaging Assistant II
N Gibitz
T Winder
Imaging Assistant
J Lund
Clinical Research
Coordinator III
A Ewer
Clinical Research
Coordinator II
R Krunkkala
K Malum
S Tasky
Clinical
Research
Coordinator III
J Bloomquist
S Logan
E Love
Training &
Development
Specialist
L Colt
Sr Research
Developer
M Unekis
TBD
Administrative
Assistant
M Ammi
Page | 77
CIBMTR 2015 Annual Report
APPENDIX B3: COORDINATING CENTER PERSONNEL
APPENDIX B3: COORDINATING CENTER LEADERSHIP
SENIOR LEADERSHIP
Mary M. Horowitz, MD, MS
• Chief Scientific Director for the CIBMTR
• Principal Investigator for the Data and Coordinating Center of the
BMT CTN
• Research Director for the SCTOD
• Robert A. Uihlein Professor of Hematologic Research at MCW
• Chief of the Division of Hematology and Oncology at MCW
• Attending physician in the MCW HCT program
Jeffrey Chell, MD
• Executive Director for the CIBMTR
• Chief Executive Officer of NMDP/Be The Match
Dennis Confer, MD
• Associate Scientific Director for CIBMTR Minneapolis
• Co-PI of the Data and Coordinating Center of the BMT CTN
• Co-Scientific Director of the RCI BMT
• Scientific Director of the Donor Health and Safety Working Committee
• Chief Medical Officer of NMDP/Be The Match
• Treasurer of the Executive Board of the Worldwide Network for Blood
and Marrow Transplantation
Daniel Weisdorf, MD
• Senior Research Advisor for the CIBMTR
• Scientific Director of the Acute Leukemia Working Committee
• Vice President of the Worldwide Network for Blood and Marrow
Transplantation
• Professor of Medicine at the University of Minnesota
• Chief of the Division of Hematology, Oncology, and Transplant at the
University of Minnesota
• Associate Chair of Clinical Research in the Department of Medicine at
the University of Minnesota
• Attending physician in the University of Minnesota HCT program
Page | 78
CIBMTR 2015 Annual Report
APPENDIX B3: COORDINATING CENTER PERSONNEL
Mei-Jie Zhang, PhD
• Chief Statistical Director for the CIBMTR
• Biostatistician for the Acute Leukemia and Graft Sources and
Manipulation Working Committees
• Professor of Biostatistics at MCW
Mary Eapen, MBBS, MS
• Senior Scientific Director of Research Operations for the CIBMTR
• Scientific Director for the Graft Sources and Manipulation Working
Committee as well as the Primary Immune Deficiencies, Inborn Errors
of Metabolism and Other Non-Malignant Marrow Disorders Working
Committee
• Protocol Officer for several BMT CTN trials
• Professor of Medicine at MCW
• Attending physician in the MCW HCT program
J. Douglas Rizzo, MD, MS
• Senior Scientific Director and Principal Investigator of the SCTOD for
the CIBMTR
• Professor of Medicine at MCW
• Associate Director of Clinical Operations for the Froedtert and MCW
Cancer Center
• Attending physician in the MCW HCT program
Bronwen Shaw MD, PhD
• Senior Scientific Director of Data Operations for the CIBMTR
• Co-Scientific Director of the RCI BMT
• Scientific Director of the Late Effects and Quality of Life Working
Committee as well as the Donor Health and Safety Working
Committee
• Professor of Medicine at MCW
• Attending physician in the MCW HCT program
Page | 79
CIBMTR 2015 Annual Report
APPENDIX B3: COORDINATING CENTER PERSONNEL
Linda Burns, MD
• Senior Scientific Director of the Health Services Research Program for
the CIBMTR
• Co-Scientific Director of the RCI BMT
• Vice President and Medical Director of NMDP/Be The Match
• Immediate Past President of the American Society of Hematology
Marcelo Pasquini, MD, MS
• Senior Scientific Director of CIBMTR Clinical Trials Support – BMT CTN
for the CIBMTR
• Scientific Director for the Autoimmune Diseases and Cellular
Therapies Working Committee as well as the Regimen-Related
Toxicity and Supportive Care Working Committee
• Protocol Officer and Director of Medical Monitors for the BMT CTN
• CIBMTR representative to the Worldwide Network for Blood and
Marrow Transplantation
• Associate Professor of Medicine at MCW
• Attending physician in the MCW HCT program
Roberta King, MPH
• Vice President for CIBMTR Minneapolis
• Oversees the administrative, scientific, and statistical support
activities of CIBMTR Minneapolis, which include research
administration, human subject protection program, data
management, auditing and monitoring, observational research,
prospective research, and IT
• Staff Liaison to the NMDP/Be The Match Donor and Patient Safety
Monitoring Advisory Group
Patricia Steinert, PhD, MBA
• Administrator for CIBMTR Milwaukee
• Oversees the administrative, scientific, and statistical support
activities of CIBMTR Milwaukee, which include data operations,
development, observational research and prospective research, IT and
meetings
Page | 80
CIBMTR 2015 Annual Report
APPENDIX B3: COORDINATING CENTER PERSONNEL
SCIENTIFIC DIRECTORS
Mukta Arora, MD, MBBS, MS
• Scientific Director of the Graft-versus-Host Disease Working
Committee
• Associate Professor of Medicine at the University of Minnesota
• Attending physician in the University of Minnesota HCT program
Anita D’Souza, MD
• Assistant Scientific Director of the Plasma Cell Disorders and Adult
Solid Tumors Working Committee
• Assistant Professor of Medicine at MCW
• Attending physician in the MCW HCT program
Parameswaran Hari, MD, MS
• Scientific Director of the Plasma Cell Disorders and Adult Solid Tumors
Working Committee
• Armand J. Quick – William F. Stapp Professor of Hematology at MCW
• Section Head of Hematologic Malignancies and Adult BMT Program at
MCW
• Attending physician in the MCW HCT program
Mehdi Hamadani, MD
• Scientific Director of the Lymphoma Working Committee
• Associate Professor of Medicine at MCW
• Attending physician in the MCW HCT program
Page | 81
CIBMTR 2015 Annual Report
APPENDIX B3: COORDINATING CENTER PERSONNEL
Stephanie J. Lee, MD, MPH
• Senior Scientific Director of Immunobiology Research for the CIBMTR
• Scientific Director of the Immunobiology Working Committee
• Professor of Medicine at the University of Washington
• Attending physician in the Fred Hutchinson Cancer Research Center
HCT program
Martin Maiers, MS
• Director of Bioinformatics Research for the CIBMTR
• Staff liaison to the NMDP/Be The Match Histocompatibility Advisory
Group (also known as the CIBMTR Immunobiology Steering
Committee)
• Co-Chair of Informatics: International Histocompatibility and
Immunogenetics Workshop
• Member of World Health Organization HLA Nomenclature Committee
Marcie Riches, MD, MS
• Scientific Director of the Infection and Immune Reconstitution
Working Committee
• Protocol Officer and Medical Monitor for several BMT CTN trials
• Clinical Associate Professor of Medicine at the University of North
Carolina at Chapel Hill
• Director of BMT Clinical Research and Data Quality at the University of
North Carolina at Chapel Hill
• Attending physician in the University of North Carolina Lineberger
Comprehensive Cancer Center HCT program
Wael Saber, MD, MS
• Scientific Director of the Chronic Leukemia and Health Services and
International Studies Working Committees
• Assistant Scientific Director of the Acute Leukemia Working
Committee
• Assistant Professor of Medicine at MCW
• Attending physician in the MCW HCT program
Page | 82
CIBMTR 2015 Annual Report
APPENDIX B3: COORDINATING CENTER PERSONNEL
Stephen Spellman, MBS
• Scientific Director of the Graft-versus-Host Disease and
Immunobiology Working Committees
• Director of Immunobiology and Observational Research for the
CIBMTR
• Principal Investigator for the Research Repository
• Staff liaison to the NMDP/Be The Match Cord Blood Advisory Group
Research subcommittee and Histocompatibility Advisory Group (also
known as the CIBMTR Immunobiology Steering Committee)
• Program Manager for the NMDP/Be The Match Office of Naval
Research Grant
Elizabeth Thiel, MD, MS
• Scientific Director of the Pediatric Cancer Working Committee
• Associate Professor of Medicine at MCW
• Attending physician in the MCW Palliative Care program
STATISTICAL DIRECTORS
Kwang Woo Ahn, PhD
• Biostatistician for the Chronic Leukemia, Infection and Immune
Reconstitution, and Lymphoma Working Committees
• Associate Professor of Biostatistics at MCW
Ruta Brazauskas, PhD
• Biostatistician for the Health Services and International Studies
Working Committee as well as the Late Effects and Quality of Life and
Autoimmune Disorders and Cellular Therapies Working Committees
• Assistant Professor of Biostatistics at MCW
Page | 83
CIBMTR 2015 Annual Report
APPENDIX B3: COORDINATING CENTER PERSONNEL
Brent Logan, PhD
• Biostatistician for the Donor Health and Safety Working Committee
and the Regimen-Related Toxicity and Supportive Care Working
Committee
• Lead Statistician for the BMT CTN and Statistical Consultant to the
NMDP/Be The Match
• Professor of Biostatistics at MCW
• Director of the Division of Biostatistics at MCW
Tao Wang, PhD
• Biostatistician for the Graft-versus-Host Disease and Immunobiology
Working Committees
• Associate Professor of Biostatistics at MCW
OTHER LEADERSHIP STAFF
Erik Bergman, MBA, MS
• Director of IT for the CIBMTR in Milwaukee
• Leads the IT staff in Milwaukee, which is organized in four teams:
Database, Applications Development, Technology Services, and
Project Management
• Oversees management of the Research Database, including extraction
of data from source systems as well as their transformation and
loading to the database
• Responsible for data retrievals from the Research Database as well as
key solutions for sharing data with stakeholders
Janet Brunner-Grady, PA-C
• Program Director of Data Operations for the CIBMTR
• Manages the clinical research coordinators, develops training
programs, and monitors transplant center CPI
• Assists clinical research coordinators on both campuses with clinical
transplant-related questions
Page | 84
CIBMTR 2015 Annual Report
APPENDIX B3: COORDINATING CENTER PERSONNEL
Debra Christianson
• Senior Manager of Auditing and Monitoring for the CIBMTR
• Oversees the monitoring program for RCI BMT clinical trials and the
on-site source document audits on data submitted to the Research
Database
• Responsible for the FormsNet Instruction Manual
Rebecca Drexler
• Senior Manager of Prospective Research for the CIBMTR
• Manages the activities of the RCI BMT, including the Survey Research
Group
• Oversees the administration of the Clinical Trials Advisory Committee
Sherry Fisher
• Director of Advancement for the CIBMTR
• Manages the advancement activities and the Corporate Program,
which generates new revenue to create a continued source of nonfederal financial support
• Oversees meetings and communications activities, including the
annual BMT Tandem Meetings
Marie Matlack
• Senior Manager of Data Management for the CIBMTR
• Manages clinical research coordinators and senior research
programmers as well as data entry and imaging staff
• Oversees form revision and development and the CPI program
• Collaborates with the Minneapolis IT staff to develop enhancements
to FormsNet
Page | 85
CIBMTR 2015 Annual Report
APPENDIX B3: COORDINATING CENTER PERSONNEL
Waleska S. Pérez, MPH
• Program Director of Statistics and Clinical Outcomes Research for the
CIBMTR
• Oversees the Master’s-level statisticians of CIBMTR Milwaukee
• Provides administrative oversight of the Clinical Outcomes Research
Program
Matt Prestegaard
• Director of IT for the CIBMTR in Minneapolis
• Leads the IT staff in Minneapolis, including project managers,
programmer analysts, business systems and data analysts, quality
assurance analysts, metadata analysts, and managers
• Develops, implements, and supports CIBMTR electronic data
management, capture, and messaging systems (FormsNet and AGNIS);
data marts and data warehouses; infrastructure for these
applications; and the curation of common data elements within the
Cancer Data Standards Registry and Repository
Page | 86
CIBMTR 2015 Annual Report
APPENDIX C1: ADVISORY COMMITTEE MEMBERSHIP
APPENDIX C: COMMITTEE MEMBERSHIP
CIBMTR committees provide input and advice to the leadership team, ensuring the continued support
of both the needs and priorities of its scientific and medical communities. All committees and their
functions are listed in Table 1.3.
APPENDIX C1: ADVISORY COMMITTEE MEMBERSHIP
The Advisory Committee provides oversight for CIBMTR policies and scientific agenda and also
partners with the Working Committees to prioritize scientific studies. Members are elected to threeyear terms by the CIBMTR Assembly and must be from qualifying CRF transplant centers. All Advisory
Committee terms begin on March 1.
ELECTED MEMBERS
Chair
Paul Martin, MD, Fred Hutchinson Cancer Research Center, Seattle, WA
Immediate Past Chair
Thomas Shea, MD, University of North Carolina at Chapel Hill, NC
VICE CHAIRS
North America
Helen Heslop, MD, Baylor College of Medicine Center for Cell and Gene
Therapy, Houston, TX
Europe
Charles Craddock, MD, PhD, Queen Elizabeth Hospital, Birmingham, United
Kingdom
Central / South America Carmem Bonfim, MD, Hospital de Clinicas – UFPR, Curitiba, Brazil
Asia / Africa / Australia Mahmoud Aljurf, MD, MPH, King Faisal Specialist Hospital Center & Research,
Riyadh, Saudi Arabia
MEMBERS AT LARGE
North America
Steven Pavletic, MD, MS, NIH-NCI Experimental Transplantation and
Immunology Branch, Bethesda, MD
Joseph Pidala, MD, MS, H Lee Moffitt Cancer Center and Research Institute,
Tampa, FL
Michael Pulsipher, MD, Primary Children’s Hospital, Salt Lake City, UT
Bipin Savani, MD, Vanderbilt University Medical Center, Brentwood, TN
Marcel van den Brink, MD, PhD, Memorial Sloan Kettering Cancer Center,
New York, NY
Kirsten Williams, MD, Children’s National Medical Center, Washington, DC
Non-North America
Ernst Holler, MD, Klinikum der Universitaet Regensburg, Germany
William Hwang, MBBS, MRCP, Singapore General Hospital, Singapore
Shinichiro Okamoto, MD, PhD, Keio University, Shinjuku-ku Tokyo, Japan
Page | 87
CIBMTR 2015 Annual Report
APPENDIX C1: ADVISORY COMMITTEE MEMBERSHIP
Miguel Sanz, Hospital Universitario La Fe, Valencia, Spain
Alok Srivastava, MD, Christian Medical College, Vellore, India
Afonso Vigorito, MD, PhD, Unicamp – Hemocentro, Campinas, Brazil
APPOINTED MEMBERS
ASBMT Representative
Christopher Bredeson, MD, MSc, The Ottawa Hospital Blood &
Marrow Transplant Program, Ottawa, Canada
Bioethicist
Steven Joffe, MD, MPH, Abramson Cancer Center University of
Pennsylvania Medical Center, Philadelphia, PA
Business Representative
Theresa Franco, MSN, BSN, Nebraska Medicine, Omaha, NE
Collection Center Representative
Lee Ann Weitekamp, MD, Michigan Blood Cord Blood Bank, Grand
Rapids, MI
Cord Blood Bank Representative
Elizabeth Shpall, MD, MD Anderson Cord Blood Bank, Houston, TX
Donor Center Representative
Jason Gangewere, NMDP/Be The Match, Minneapolis, MN
Patient / Family Representatives
James Omel, MD, Chair, Consumer Advocacy Committee
Maureen Beaman, MBA, Chair, Consumer Advocacy Committee
EX OFFICIO MEMBERS
Executive Director
Jeffrey Chell, MD, NMDP/Be The Match, Minneapolis, MN
Chief Scientific Director
Mary M. Horowitz, MD, MS, CIBMTR, Milwaukee, WI
Chief Statistical Director
Mei-Jie Zhang, PhD, CIBMTR, Milwaukee, WI
Senior Scientific Director for SCTOD
J. Douglas Rizzo, MD, MS, CIBMTR, Milwaukee, WI
Associate Scientific Director CIBMTR Minneapolis
Dennis Confer, MD, CIBMTR, Minneapolis, MN
Senior Research Advisor
Daniel Weisdorf, MD, CIBMTR, Minneapolis, MN
Research Administrator CIBMTR Milwaukee
Patricia Steinert, PhD, MBA, CIBMTR, Milwaukee, WI
Vice President CIBMTR Minneapolis
Roberta King, CIBMTR, Minneapolis, MN
Vice President Patient Services
Elizabeth Murphy, EdD, RN, NMDP/Be The Match, Minneapolis,
MN
NMDP / MCW / HRSA Contracting Officer Representative
Shelley Grant, MHSA, Rockville, MD
NMDP / Navy Project Officer
Robert Hartzman, MD, Capt. MC, USN (ret)
MCW / HRSA Contracting Officer Representative
Christine Nishiguchi, MS, MPH, Rockville, MD
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CIBMTR 2015 Annual Report
APPENDIX C1: ADVISORY COMMITTEE MEMBERSHIP
MCW / NCI Project Officer
Roy Wu, PhD, Bethesda, MD
MCW / NHLBI Project Officer
Nancy DiFronzo, PhD, Bethesda, MD
MCW / NIAID Project Officer
Linda Griffith, MD, PhD, Bethesda, MD
Nominating Committee Chair
Stella Davies, PhD, MBBS, Cincinnati Children’s Hospital Medical
Center, Cincinnati, OH
Page | 89
CIBMTR 2015 Annual Report
APPENDIX C2: EXECUTIVE COMMITTEE MEMBERSHIP
APPENDIX C2: EXECUTIVE COMMITTEE MEMBERSHIP
The Executive Committee, a subcommittee of the Advisory Committee, ensures that the organization
carries out its mission and adheres to CIBMTR policies and procedures; it also provides advice and
counsel to the Coordinating Center between meetings of the Advisory Committee. Specifically, the
Executive Committee is responsible for providing scientific and policy advice to the Chief Scientific
Director and Coordinating Center, reviewing audit results and making recommendations for
improvement, and appointing a CIBMTR Co-Chair and additional CIBMTR representatives to the BMT
Tandem Meetings Scientific Organizing Committee for the annual BMT Tandem Meetings. All
Executive Committee terms begin on March 1.
ELECTED MEMBERS
Chair
Paul Martin, MD, Fred Hutchinson Cancer Research Center,
Seattle, WA
Immediate Past Chair
Thomas Shea, MD, University of North Carolina at Chapel Hill, NC
VICE CHAIRS
North America
Helen Heslop, MD, Baylor College of Medicine Center for Cell and
Gene Therapy, Houston, TX
Europe
Charles Craddock, MD, PhD, Queen Elizabeth Hospital,
Birmingham, United Kingdom
Central / South America
Carmem Bonfim, MD, Hospital de Clinicas – UFPR, Curitiba, Brazil
Asia / Africa / Australia
Mahmoud Aljurf, MD, MPH, King Faisal Specialist Hospital Center
& Research, Riyadh, Saudi Arabia
APPOINTED MEMBERS
ASBMT Representative
Christopher Bredeson, MD, MSc, The Ottawa Hospital Blood &
Marrow Transplant Program, Ottawa, Canada
Bioethicist
Steven Joffe, MD, MPH, Abramson Cancer Center University of
Pennsylvania Medical Center, Philadelphia, PA
Business Representative
Theresa Franco, MSN, BSN, Nebraska Medicine, Omaha, NE
Collection Center Representative
Lee Ann Weitekamp, MD, Michigan Blood Cord Blood Bank, Grand
Rapids, MI
Cord Blood Bank Representative
Elizabeth Shpall, MD, MD Anderson Cord Blood Bank, Houston, TX
Donor Center Representative
Jason Gangewere, NMDP/Be The Match, Minneapolis, MN
Patient / Family Representatives
James Omel, MD, Chair, Consumer Advocacy Committee
Maureen Beaman, MBA, Chair, Consumer Advocacy Committee
Page | 90
CIBMTR 2015 Annual Report
APPENDIX C2: EXECUTIVE COMMITTEE MEMBERSHIP
EX OFFICIO MEMBERS
Executive Director
Jeffrey Chell, MD, NMDP/Be The Match, Minneapolis, MN
Chief Scientific Director
Mary M. Horowitz, MD, MS, CIBMTR, Milwaukee, WI
Chief Statistical Director
Mei-Jie Zhang, PhD, CIBMTR, Milwaukee, WI
Senior Scientific Director for SCTOD
J. Douglas Rizzo, MD, MS, CIBMTR, Milwaukee, WI
Associate Scientific Director CIBMTR Minneapolis
Dennis Confer, MD, CIBMTR, Minneapolis, MN
Senior Research Advisor
Daniel Weisdorf, MD, CIBMTR, Minneapolis, MN
Research Administrator CIBMTR Milwaukee
Patricia Steinert, PhD, MBA, CIBMTR, Milwaukee, WI
Vice President CIBMTR Minneapolis
Roberta King, CIBMTR, Minneapolis, MN
Vice President Patient Services
Elizabeth Murphy, EdD, RN, NMDP/Be The Match, Minneapolis,
MN
NMDP / MCW /HRSA Contracting Officer Representative
Shelley Grant, MHSA, Rockville, MD
NMDP / Navy Project Officer
Robert Hartzman, MD, Capt. MC, USN (ret)
MCW / HRSA Contracting Officer Representative
Christine Nishiguchi, MS, MPH, Rockville, MD
MCW / NCI Project Officer
Roy Wu, PhD, Bethesda, MD
MCW / NHLBI Project Officer
Nancy DiFronzo, PhD, Bethesda, MD
MCW / NIAID Project Officer
Linda Griffith, MD, PhD, Bethesda, MD
Nominating Committee Chair
Stella Davies, PhD, MBBS, Cincinnati Children’s Hospital Medical
Center, Cincinnati, OH
Page | 91
CIBMTR 2015 Annual Report
APPENDIX C3: CONSUMER ADVOCACY COMMITTEE MEMBERSHIP
APPENDIX C3: CONSUMER ADVOCACY COMMITTEE MEMBERSHIP
The Consumer Advocacy Committee communicates research results and data to the non-medical
community and provides patient and donor perspectives during the development of the CIBMTR
research agenda. Many committee members have personal experience as a donor, recipient, or
family member of a recipient.
CHAIRS
James Omel, MD
Maureen Beaman, MBA
MEMBERS
Beatrice Abetti, MSW, Leukemia and Lymphoma Society
Jack Aiello, MS
Gerardo Camarillo, JD, MD Anderson Cancer Center
Jeffrey Haertling, ARK Air Express
Hilary Hall, Dana-Farber Cancer Institute
Barry Schatz, Cardinal Bernardin Cancer Center, Loyola University Medical Center
Kristin Scheeler, University of Wisconsin Hospital and Clinics
SCIENTIFIC DIRECTOR
J. Douglas Rizzo, MD, MS, CIBMTR
EX OFFICIO MEMBERS
Robyn Ashton, RN, MSN, HRSA
Jeffrey Chell, MD, NMDP/Be The Match
Dennis Confer, MD, NMDP/Be The Match
Ellen Denzen, (NMDP/Be The Match liaison) NMDP/Be The Match
Carol Doleysh, (CIBMTR liaison) CIBMTR
Rebecca Drexler, CIBMTR
Jessica Gillis-Smith, MPH, CIBMTR
Shelley Grant, MHSA, HRSA
Darlene Haven, NMDP/Be The Match
Mary Horowitz, MD, MS, CIBMTR
Elizabeth Murphy, EdD, RN, (NMDP/Be The Match liaison) NMDP/Be The Match
Christine Nishiguchi, MS, MPH, HRSA
Patricia Steinert, PhD, MBA, CIBMTR
Page | 92
CIBMTR 2015 Annual Report
APPENDIX C4: NOMINATING COMMITTEE MEMBERSHIP
APPENDIX C4: NOMINATING COMMITTEE MEMBERSHIP
The Nominating Committee consists of five members elected by the CIBMTR Assembly. Following an
annual call for nominations, the Nominating Committee prepares a slate of candidates for open
positions on the Advisory, Nominating, and Clinical Trials Advisory Committees. Elections are held
annually by confidential electronic ballot. The Nominating Committee also makes recommendations
to the Advisory Committee for open Working Committee Chair and other leadership appointments
after seeking recommendations from the CIBMTR Assembly, Advisory Committee, and incumbent
Working Committee Chairs. All terms begin on March 1.
CHAIR
Stella Davies, PhD, MBBS, Cincinnati Children’s Hospital Medical Center, Cincinnati, OH
MEMBERS
Daniel Couriel, MD, University of Michigan, Ann Arbor, MI
Richard Champlin, MD, MD Anderson Cancer Center, Houston TX
Brenda Sandmaier, MD, Fred Hutchinson Cancer Research Center, Seattle, WA
David Vesole, MD, PhD, Hackensack University Medical Center, Hackensack, NJ
Page | 93
CIBMTR 2015 Annual Report
APPENDIX C5: SCIENTIFIC WORKING COMMITTEE LEADERSHIP
APPENDIX C5: SCIENTIFIC WORKING COMMITTEE LEADERSHIP
For information on Scientific Working Committee structure and organization, see Section 1.3.1. For
information on Working Committee studies and their accomplishments, see Section 2.1.1.
ACUTE LEUKEMIA WORKING COMMITTEE
Chairs
Marcos de Lima, MD, University Hospitals Case Medical Center
Brenda Sandmaier, MD, Fred Hutchinson Cancer Research Center
Hanna Khoury, MD, Emory University Hospital
Scientific Director Daniel Weisdorf, MD, CIBMTR
Asst Scientific Dir Wael Saber, MD, MS, CIBMTR
Statistical Director Mei-Jie Zhang, PhD, CIBMTR
Statistician
Hailin Wang, MPH, CIBMTR
AUTOIMMUNE DISEASES AND CELLULAR THERAPIES WORKING COMMITTEE
Chairs
Mitchell Cairo, MD, New York Medical College
Ian Lewis, MBBS, PhD, Royal Adelaide Hospital
David McKenna, MD, University of Minnesota Medical Center, Fairview
Stefanie Sarantopoulos, MD, PhD, Duke University Medical Center
Scientific Director Marcelo Pasquini, MD, MS, CIBMTR
Statistical Director Ruta Brazauskas, PhD, CIBMTR
Statistician
Kyle Bo-Subait, MPH, CIBMTR
CHRONIC LEUKEMIA WORKING COMMITTEE
Chairs
Edwin Alyea, MD, Dana Farber Cancer Institute
Uday Popat, MD, MD Anderson Cancer Center
Ronald Sobecks, MD, Cleveland Clinic Foundation
Scientific Director Wael Saber, MD, MS, CIBMTR
Statistical Director Kwang Woo Ahn, PhD, CIBMTR
Statistician
Zhenhuan Hu, MS, CIBMTR
DONOR HEALTH AND SAFETY WORKING COMMITTEE
Chairs
Paul O’Donnell, MD, PhD, Fred Hutchinson Cancer Research Center
Michael Pulsipher, MD, Primary Children’s Hospital
Galen Switzer, PhD, University of Pittsburgh Medical Center - Cancer Center
Scientific Director Bronwen Shaw, MD, PhD, CIBMTR
Ex Officio Sr Advisor Dennis Confer, MD, CIBMTR
Statistical Director Brent Logan, PhD, CIBMTR
Statisticians
Deidre Kiefer, MPH, CIBMTR
Pintip Chitphakdithai, PhD, CIBMTR
Consumer Advocacy Committee Representatives
Beatrice Abetti, MSW, Leukemia and Lymphoma Society
Maureen Beaman, MBA
Jeffrey Haertling, ARK Air Express
Page | 94
CIBMTR 2015 Annual Report
APPENDIX C5: SCIENTIFIC WORKING COMMITTEE LEADERSHIP
GRAFT SOURCES AND MANIPULATION WORKING COMMITTEE
Chairs
Miguel-Angel Perales, MD, Memorial Sloan Kettering Cancer Center
Vanderson Rocha, MD, PhD, Churchill Hospital
Asad Bashey, MD, PhD, The Blood and Marrow Transplant Program at Northside
Hospital
Scientific Director Mary Eapen, MBBS, MS, CIBMTR
Statistical Director Mei-Jie Zhang, PhD, CIBMTR
Statistician
Andrew St. Martin, MS, CIBMTR
GRAFT-VERSUS-HOST DISEASE WORKING COMMITTEE
Chairs
Daniel Couriel, MD, University of Michigan
Amin Alousi, MD, MD Anderson Cancer Center
Joseph Pidala, MD, PhD, H. Lee Moffitt Cancer Center and Research Institute
Scientific Directors Mukta Arora, MD, MS, CIBMTR
Stephen Spellman, MBS, CIBMTR
Statistical Director Tao Wang, PhD, CIBMTR
Statistician
Michael Hemmer, MS, CIBMTR
Consumer Advocacy Committee Representatives
Hilary Hall, Dana-Farber Cancer Institute
James Omel, MD
HEALTH SERVICES AND INTERNATIONAL STUDIES WORKING COMMITTEE
Chairs
Yoshiko Atsuta, MD, PhD, Nagoya University Graduate School of Medicine
Carmem Bonfim, MD, Hospital de Clinicas Curitiba
Jignesh Dalal, MD, The Children’s Mercy Hospitals and Clinics
Theresa Hahn, PhD, Roswell Park Cancer Institute
Nandita Khera, MD, Mayo Clinic Arizona and Phoenix Children's Hospital
Scientific Director Wael Saber, MD, MS, CIBMTR
Statistical Director Ruta Brazauskas, PhD, CIBMTR
Statistician
Naya He, MPH, CIBMTR
Consumer Advocacy Committee Representatives
Jack Aiello, MS
Gerardo Camarillo, JD, MD Anderson Cancer Center
IMMUNOBIOLOGY WORKING COMMITTEE
Chairs
Michael Verneris, MD, University of Minnesota Medical Center, Fairview
Katharina Fleischhauer, MD, Universitätsklinikum Essen KMT
Katharine Hsu, MD, PhD, Memorial Sloan Kettering Cancer Center
Scientific Directors Stephanie J. Lee, MD, MPH, CIBMTR, Fred Hutchinson Cancer Research Center
Stephen Spellman, MBS, CIBMTR
Statistical Director Tao Wang, PhD, CIBMTR
Statistician
Michael Haagenson, MS, CIBMTR
Page | 95
CIBMTR 2015 Annual Report
APPENDIX C5: SCIENTIFIC WORKING COMMITTEE LEADERSHIP
INFECTION AND IMMUNE RECONSTITUTION WORKING COMMITTEE
Chairs
Jeffery Auletta, MD, Nationwide Children’s Hospital
Caroline Lindemans, MD, PhD, University Medical Center Utrecht
Krishna Komanduri, MD, University of Miami
Scientific Director Marcie Riches, MD, MS, CIBMTR, H Lee Moffitt Cancer Center and Research
Institute
Statistical Directors Kwang Woo Ahn, PhD, CIBMTR
Soyoung Kim, PhD, CIBMTR
Statistician
Min Chen, MS, CIBMTR
LATE EFFECTS AND QUALITY OF LIFE WORKING COMMITTEE
Chairs
Bipin Savani, MD, Vanderbilt University Medical Center
Mary Flowers, MD, Fred Hutchinson Cancer Research Center
Minoo Battiwalla, MD, MS, National Heart Lung and Blood Institute - NIH
Scientific Director Bronwen Shaw, MD, PhD, CIBMTR
Statistical Director Ruta Brazauskas, PhD, CIBMTR
Statistician
Heather Millard, MPH, CIBMTR
Consumer Advocacy Committee Representative
Barry Schatz, Loyola University Medical Center
LYMPHOMA WORKING COMMITTEE
Chairs
Sonali Smith, MD, University of Chicago Hospitals
Anna Sureda, MD, PhD
Timothy Fenske, MD, MS, Froedtert Memorial Lutheran Hospital
Scientific Director Mehdi Hamadani, MD, CIBMTR
Statistical Director Kwang Woo Ahn, PhD, CIBMTR
Statistician
Alyssa DiGilio, MS, CIBMTR
PEDIATRIC CANCER WORKING COMMITTEE
Chairs
Gregory Hale, MD, All Children’s Hospital
Parinda Mehta, MD, Cincinnati Children's Hospital Medical Center
Angela Smith, MD, MS, University of Minnesota Medical Center, Fairview
Scientific Director Elizabeth Thiel, MS, CIBMTR
Statistical Director Kwang Woo Ahn, PhD, CIBMTR
Statistician
Heather Millard, MPH, CIBMTR
Page | 96
CIBMTR 2015 Annual Report
APPENDIX C5: SCIENTIFIC WORKING COMMITTEE LEADERSHIP
PLASMA CELL DISORDERS AND ADULT SOLID TUMORS WORKING COMMITTEE
Chairs
Amrita Krishnan, MD, City of Hope National Medical Center
Cristina Gasparetto, MD, Duke University Medical Center
Yago Nieto, MD, PhD, MD Anderson Cancer Center
Tomer Mark, MD, New York Presbyterian Hospital at Cornell
Scientific Director Parameswaran Hari, MD, MS, CIBMTR
Asst Scientific Dir Anita D’Souza, MD, CIBMTR
Statistical Directors Mei-Jie Zhang, PhD, CIBMTR
Raphael Fraser, PhD, CIBMTR
Statistician
Jiaxing Huang, MS, CIBMTR
Consumer Advocacy Committee Representative
James Omel, MD
PRIMARY IMMUNE DEFICIENCIES, INBORN ERRORS OF METABOLISM, AND OTHER
NON-MALIGNANT MARROW DISORDERS WORKING COMMITTEE
Chairs
Paolo Anderlini, MD, MD Anderson Cancer Center
Neena Kapoor, MD, Children’s Hospital of Los Angeles
Jaap-Jan Boelens, MD, PhD, University Medical Center Utrecht
Vikram Mathews, MD, Christian Medical College Hospital
Scientific Director Mary Eapen, MBBS, MS, CIBMTR
Statistical Director Ruta Brazauskas, PhD, CIBMTR
Statistician
TBD
REGIMEN-RELATED TOXICITY AND SUPPORTIVE CARE WORKING COMMITTEE
Chairs
Andrew Artz, MD, MS, University of Chicago Hospitals
Alison Loren, MD, MS, Abramson Cancer Center University of Pennsylvania
Medical Center
Shin Mineishi, MD, University of Alabama at Birmingham
Scientific Director Marcelo Pasquini, MD, MS, CIBMTR
Statistical Director Brent Logan, PhD, CIBMTR
Statistician
Xiaochun Zhu, MS, CIBMTR
Page | 97
CIBMTR 2015 Annual Report
APPENDIX C6: IMMUNOBIOLOGY STEERING COMMITTEE MEMBERSHIP
APPENDIX C6: IMMUNOBIOLOGY STEERING COMMITTEE MEMBERSHIP
The NMDP/Be The Match Histocompatibility Advisory Group also serves as the CIBMTR
Immunobiology Steering Committee. This committee reviews and approves the use of donorrecipient specimens from the Research Repository in CIBMTR studies.
CHAIR
Carolyn K. Hurley, PhD, Diplomate ABHI, Georgetown University Hospital
ADVISORY GROUP MEMBERS
Juliet Barker, MD, Memorial Sloan Kettering Cancer Center
Sarah Cooley, MD, University of Minnesota
Mary Eapen, MD, MS, Medical College of Wisconsin
Marcelo Fernandez-Viña, PhD, Stanford Hospital and Clinics
Brent Logan, PhD, Medical College of Wisconsin
Carlheinz Mueller, MD, PhD, German National Bone Marrow Donor Registry (ZKRD)
Joseph Pidala, MD, PhD, H. Lee Moffitt Cancer Center
David Porter, MD, Abramson Cancer Center University of Pennsylvania Medical Center
Raja Rajalingham, PhD, University of California, San Francisco
Bronwen Shaw, MD, PhD, Medical College of Wisconsin
EX OFFICIO MEMBERS
Dennis Confer, MD, NMDP/Be The Match
Jason Dehn, MPH, NMDP/Be The Match
Karen Dodson, NMDP/Be The Match
Melissa Greenwald, MD, HRSA
Robert Hartzman, MD, Capt. MC, USN (Ret.), Navy Representative, C.W. Bill Young Marrow
Donor Recruitment and Research Program
Martin Maiers, CIBMTR
Stephen Spellman, MBS, CIBMTR
John Wingard, MD, NMDP/Be The Match Board Chair
Page | 98
CIBMTR 2015 Annual Report
APPENDIX C7: CLINICAL TRIALS ADVISORY COMMITTEE MEMBERSHIP
APPENDIX C7: CLINICAL TRIALS ADVISORY COMMITTEE MEMBERSHIP
The Clinical Trials Advisory Committee assists in the review, approval, and oversight of proposals and
protocols for Phase I and Phase II clinical trials submitted to the RCI BMT (Section 2.3.2).
CHAIR
John Levine, MD, MS, Mount Sinai Medical Center
MEMBERS
Colleen Delaney, MD, MSc, Fred Hutchinson Cancer Research Center
Marcos de Lima, MD, University Hospitals Case Medical Center
Hugo Fernandez, MD, H Lee Moffitt Cancer Center and Research Institute
John Koreth, MBBS, DPhil, Dana Farber Cancer Institute
Mark Litzow, MD, Mayo Clinic Rochester
Margaret MacMillan, MD, MSc, University of Minnesota Medical Center, Fairview
Sophie Paczesny, MD, PhD, Indiana University Hospital/Riley Hospital for Children
Katayoun Rezvani, MD, PhD, M.D. Anderson Cancer Center
Jan Storek, MD, PhD, University of Calgary
APPOINTED MEMBERS
Maureen Beaman, MBA
James Omel, MD
EX OFFICIO MEMBERS
Dennis Confer, MD, CIBMTR
Rebecca Drexler, BS, CIBMTR
Robert Hartzman, MD, Capt MC, USN (Ret.)
Mary Horowitz, MD, MS, CIBMTR
Roberta King, CIBMTR
Brent Logan, PhD, CIBMTR
Nancy Poland, MA, NMDP/Be The Match Operations
Marcie Riches, MD, MS, The University of North Carolina at Chapel Hill
Kevin Weber, NMDP/Be The Match Operations
Daniel Weisdorf, MD, CIBMTR
Page | 99
CIBMTR 2015 Annual Report
APPENDIX D1: SCIENTIFIC WORKING COMMITTEE PUBLICATIONS
APPENDIX D: PUBLICATIONS
The PMCID number is assigned by PubMed Central, the NIH’s free digital archive of biomedical and
life sciences journal literature, and is in compliance with the NIH policy on public access.
APPENDIX D1: SCIENTIFIC WORKING COMMITTEE PUBLICATIONS
The following publications were generated by Scientific Working Committees within the Clinical
Outcomes Research Program. For more information about the Working Committees, see Section
2.1.1.
SCIENTIFIC WORKING COMMITTEE PUBLICATIONS
Authors
Title
Citation
PMCID
Logan AC, Wang Z,
Alimoghaddam K, Wong RM,
Lai T, Negrin RS, Grumet C,
Logan BR, Zhang M-J,
Spellman SR, Lee SJ, Miklos
DB
ABO mismatch is
associated with increased
nonrelapse mortality
after allogeneic
hematopoietic cell
transplantation
PMC4363312
Gadalla SM, Wang T,
Haagenson M, Spellman SR,
Lee SJ, Williams KM, Wong
JY, De Vivo I, Savage SA
Association between
donor leukocyte
telomere length and
survival after unrelated
allogeneic hematopoietic
cell transplantation for
severe aplastic anemia
Impact of conditioning
regimen on outcomes for
patients with lymphoma
undergoing high-dose
therapy with autologous
hematopoietic cell
transplantation
Biology of Blood and
Marrow
Transplantation:
Journal of the
American Society for
Blood and Marrow
Transplantation. 2015
Apr 1; 21(4):746-754.
doi:10.1016/j.bbmt.
2014.12.036. Epub
2015 Jan 5
JAMA: The Journal of
the American Medical
Association. 2015 Feb
10; 313(6):594-602.
doi:10.1001/
jama.2015.7. Epub
2015 Feb 10
Biology of Blood and
Marrow
Transplantation:
Journal of the
American Society for
Blood and Marrow
Transplantation. 2015
Jun 1; 21(6):10461053. doi:10.1016/
j.bbmt.2015.02.005.
Epub 2015 Feb 13
Chen Y-B, Lane AA, Logan BR,
Zhu X, Akpek G, Aljurf MD,
Artz AS, Bredeson CN, Cooke
KR, Ho VT, Lazarus HM,
Olsson RF, Saber W,
McCarthy PL, Pasquini MC
PMC4388056
PMC4426014
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CIBMTR 2015 Annual Report
APPENDIX D1: SCIENTIFIC WORKING COMMITTEE PUBLICATIONS
SCIENTIFIC WORKING COMMITTEE PUBLICATIONS
Authors
Title
Citation
PMCID
Veys PA, Nanduri V, Baker
KS, He W, Bandini G, Biondi
A, Dalissier A, Davis JH,
Eames GM, Egeler RM,
Filipovich AH, Fischer A,
Jürgens H, Krance R, Lanino
E, Leung WH, Matthes S,
Michel G, Orchard PJ,
Pieczonka A, Ringdén O,
Schlegel PG, Sirvent A,
Vettenranta K, Eapen M
Inamoto Y, Shah NN, Savani
BN, Shaw BE, Abraham AA,
Ahmed IA, Akpek G, Atsuta Y,
Baker KS, Basak GW, Bitan M,
DeFilipp Z, Gregory TK,
Greinix HT, Hamadani M,
Hamilton BK, Hayashi RJ,
Jacobsohn DA, Kamble RT,
Kasow KA, Khera N, Lazarus
HM, Malone AK, LupoStanghellini MT, Margossian
SP, Muffly LS, Norkin M,
Ramanathan M, Salooja N,
Schoemans H, Wingard JR,
Wirk B, Wood WA, Yong A,
Duncan CN, Flowers MED,
Majhail NS
Holter-Chakrabarty JL,
Pierson N, Zhang M-J, Zhu X,
Akpek G, Aljurf MD, Artz AS,
Baron F, Bredeson CN,
Dvorak CC, Epstein RB,
Lazarus HM, Olsson RF, Selby
GB, Williams KM, Cooke KR,
Pasquini MC, McCarthy PL
Haematopoietic stem cell
transplantation for
refractory Langerhans
cell histiocytosis:
outcome by intensity of
conditioning
British Journal of
PMC4433436
Haematology. 2015 Jun
1; 169(5):711-718.
doi:10.1111/bjh.13347.
Epub 2015 Mar 27
Secondary solid cancer
screening following
hematopoietic cell
transplantation
Bone Marrow
Transplantation. 2015
Aug 1; 50(8):10131023. doi:10.1038/
bmt.2015.63. Epub
2015 Mar 30
N/A
The sequence of
cyclophosphamide and
myeloablative total body
irradiation in
hematopoietic cell
transplantation for
patients with acute
leukemia
Biology of Blood and
Marrow
Transplantation:
Journal of the
American Society for
Blood and Marrow
Transplantation. 2015
Jul 1; 21(7):1251-1257.
doi:10.1016/j.bbmt.
2015.03.017. Epub
2015 Mar 31
PMC4465990
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CIBMTR 2015 Annual Report
APPENDIX D1: SCIENTIFIC WORKING COMMITTEE PUBLICATIONS
SCIENTIFIC WORKING COMMITTEE PUBLICATIONS
Authors
Title
Citation
PMCID
Sorror ML, Logan BR, Zhu X,
Rizzo JD, Cooke KR, McCarthy
PL, Ho VT, Horowitz MM,
Pasquini MC
Prospective validation of
the predictive power of
the hematopoietic cell
transplantation
comorbidity index: a
Center for International
Blood and Marrow
Transplant Research
study
PMC4512746
Mehta PA, Zhang M-J, Eapen
M, He W, Seber A, Gibson B,
Camitta BM, Kitko CL, Dvorak
CC, Nemecek ER, Frangoul
HA, Abdel-Azim H, Kasow KA,
Lehmann L, Gonzalez Vicent
M, Diaz Pérez MA, Ayas M,
Qayed M, Carpenter PA,
Jodele S, Lund TC, Leung WH,
Davies SM
Transplant outcomes for
children with hypodiploid
acute lymphoblastic
leukemia
Olsson RF, Logan BR,
Chaudhury S, Zhu X, Akpek G,
Bolwell BJ, Bredeson CN,
Dvorak CC, Gupta V, Ho VT,
Lazarus HM, Marks DI,
Ringdén OTH, Pasquini MC,
Schriber JR, Cooke KR
Goyal SD, Zhang MJ, Wang
HL, Akpek G, Copelan EA,
Freytes C, Gale RP, Hamadani
M, Inamoto Y, Kamble RT,
Lazarus HM, Marks DI,
Nishihori T, Olsson RF,
Reshef R, Ritchie DS, Saber
W, Savani BN, Seber A, Shea
TC, Tallman MS, Wirk B,
Bunjes DW, Devine SM, de
Lima M, Weisdorf DJ, Uy GL
Primary graft failure after
myeloablative allogeneic
hematopoietic cell
transplantation for
hematologic
malignancies
Biology of Blood and
Marrow
Transplantation:
Journal of the
American Society for
Blood and Marrow
Transplantation. 2015
Aug 1; 21(8):14791487. doi:10.1016/
j.bbmt.2015.04.004.
Epub 2015 Apr 7
Biology of Blood and
Marrow
Transplantation:
Journal of the
American Society for
Blood and Marrow
Transplantation. 2015
Jul 1; 21(7):1273-1277.
doi:10.1016/j.bbmt.
2015.04.008. Epub
2015 Apr 10
Leukemia. 2015 Aug 1;
29(8):1754-1762.
doi:10.1038/leu.
2015.75. Epub 2015
Apr 24
Bone Marrow
Transplantation. 2015
Aug 1; 50(8):10571062. doi:10.1038/
bmt.2015.82. Epub
2015 Apr 27
PMC4527880
Allogeneic hematopoietic
cell transplant for AML:
no impact of pretransplant
extramedullary disease
on outcome
PMC4465998
PMC4527886
Page | 102
CIBMTR 2015 Annual Report
APPENDIX D1: SCIENTIFIC WORKING COMMITTEE PUBLICATIONS
SCIENTIFIC WORKING COMMITTEE PUBLICATIONS
Authors
Title
Citation
PMCID
Sobecks RM, Wang T, Askar
M, Gallagher MM,
Haagenson M, Spellman S,
Fernandez-Vina M,
Malmberg K-J, Müller C,
Battiwalla M, Gajewski J,
Verneris MR, Ringdén O,
Marino S, Davies S, Dehn J,
Bornhäuser M, Inamoto Y,
Woolfrey A, Shaw P, Pollack
M, Weisdorf D, Milller J,
Hurley C, Lee SJ, Hsu K
Bachanova V, Burns LJ, Ahn
KW, Laport GG, Akpek G,
Kharfan-Dabaja MA,
Nishihori T, Agura E, Armand
P, Jaglowski SM, Cairo MS,
Cashen AF, Cohen JB,
D'Souza A, Freytes CO, Gale
RP, Ganguly S, Ghosh N,
Holmberg LA, Inwards DJ,
Kanate AS, Lazarus HM,
Malone AK, Munker R,
Mussetti A, Norkin M,
Prestidge TD, Rowe JM,
Satwani P, Siddiqi T, Stiff PJ,
William BM, Wirk B, Maloney
DG, Smith SM, Sureda AM,
Carreras J, Hamadani M
Impact of KIR and HLA
genotypes on outcomes
after reduced-intensity
conditioning
hematopoietic cell
transplantation
Biology of Blood and
Marrow
Transplantation:
Journal of the
American Society for
Blood and Marrow
Transplantation. 2015
Sep 1; 21(9):15891596. doi:10.1016/
j.bbmt.2015.05.002.
Epub 2015 May 8
PMC4537837
Impact of
pretransplantation 18Ffluorodeoxy glucosepositron emission
tomography status on
outcomes after
allogeneic hematopoietic
cell transplantation for
non-Hodgkin Lymphoma
Biology of Blood and
Marrow
Transplantation:
Journal of the
American Society for
Blood and Marrow
Transplantation. 2015
Sep 1; 21(9):16051611. doi:10.1016/
j.bbmt.2015.05.007.
Epub 2015 May 14
PMC4558181
Page | 103
CIBMTR 2015 Annual Report
APPENDIX D1: SCIENTIFIC WORKING COMMITTEE PUBLICATIONS
SCIENTIFIC WORKING COMMITTEE PUBLICATIONS
Authors
Title
Citation
PMCID
Urbano-Ispizua A, Pavletic SZ,
Flowers ME, Klein JP, Zhang
M-J, Carreras J, Montoto S,
Perales M-A, Aljurf MD,
Akpek G, Bredeson CN, Costa
LJ, Dandoy C, Freytes CO,
Fung HC, Gale RP, Gibson J,
Hamadani M, Hayashi RJ,
Inamoto Y, Inwards DJ,
Lazarus HM, Maloney DG,
Martino R, Munker R,
Nishihori T, Olsson RF,
Rizzieri DA, Reshef R, Saad A,
Savani BN, Schouten HC,
Smith SM, Socié G, Wirk B, Yu
LC, Saber W
Orchard PJ, Fasth AL, Le
Rademacher J, He W,
Boelens JJ, Horwitz EM, AlSeraihy A, Ayas M, Bonfim
CM, Boulad F, Lund T,
Buchbinder DK, Kapoor N,
O'Brien TA, Diaz Perez MA,
Veys PA, Eapen M
Hahn T, Sucheston-Campbell
LE, Preus L, Zhu X, Hansen JA,
Martin PJ, Yan L, Liu S,
Spellman S, Tritchler D, Clay
A, Onel K, Pasquini M,
McCarthy PL
The impact of graftversus-host disease on
the relapse rate in
patients with lymphoma
depends on the
histological subtype and
the intensity of the
conditioning regimen
Biology of Blood and
Marrow
Transplantation:
Journal of the
American Society for
Blood and Marrow
Transplantation. 2015
Oct 1; 21(10):17461753. doi:10.1016/
j.bbmt.2015.05.010.
Epub 2015 May 15
PMC4568162
Hematopoietic stem cell
transplantation for
infantile osteopetrosis
Blood. 2015 Jul 9;
126(2):270-276.
doi:10.1182/blood2015-01-625541. Epub
2015 May 26
PMC4497967
Establishment of
definitions and review
process for consistent
adjudication of causespecific mortality after
allogeneic unrelateddonor hematopoietic cell
transplantation
Biology of Blood and
Marrow
Transplantation:
Journal of the
American Society for
Blood and Marrow
Transplantation. 2015
Sep 1; 21(9):16791686. doi:10.1016/
j.bbmt.2015.05.019.
Epub 2015 May 29
PMC4537799
Page | 104
CIBMTR 2015 Annual Report
APPENDIX D1: SCIENTIFIC WORKING COMMITTEE PUBLICATIONS
SCIENTIFIC WORKING COMMITTEE PUBLICATIONS
Authors
Title
Citation
PMCID
Inamoto Y, Flowers MED,
Wang T, Urbano-Ispizua A,
Hemmer MT, Cutler CS,
Couriel DR, Alousi AM, Antin
JH, Gale RP, Gupta V,
Hamilton BK, Kharfan-Dabaja
MA, Marks DI, Ringdén OTH,
Socié G, Solh MM, Akpek G,
Cairo MS, Chao NJ, Hayashi
RJ, Nishihori T, Reshef R,
Saad A, Shah A, Teshima T,
Tallman MS, Wirk B,
Spellman SR, Arora M,
Martin PJ
Verneris MR, Lee SJ, Ahn KW,
Wang H-L, Battiwalla M,
Inamoto Y, Fernandez-Vina
MA, Gajewski J, Pidala J,
Munker R, Aljurf M, Saber W,
Spellman S, Koreth J
Tacrolimus versus
cyclosporine after
hematopoietic cell
transplantation for
acquired aplastic anemia
Biology of Blood and
Marrow
Transplantation:
Journal of the
American Society for
Blood and Marrow
Transplantation. 2015
Oct 1; 21(10):17761782. doi:10.1016/
j.bbmt.2015.05.023.
Epub 2015 May 30
PMC4568149
HLA mismatch Is
associated with worse
outcomes after unrelated
donor reduced-intensity
conditioning
hematopoietic cell
transplantation: an
analysis from the Center
for International Blood
and Marrow Transplant
Research
Comparison of
characteristics and
outcomes of trial
participants and
nonparticipants: example
of Blood and Marrow
Transplant Clinical Trials
Network 0201 trial
Biology of Blood and
Marrow
Transplantation:
Journal of the
American Society for
Blood and Marrow
Transplantation. 2015
Oct 1; 21(10):17831789. doi:10.1016/
j.bbmt.2015.05.028.
Epub 2015 Jun 6
Biology of Blood and
Marrow
Transplantation:
Journal of the
American Society for
Blood and Marrow
Transplantation. 2015
Oct 1; 21(10):18151822. doi:10.1016/
j.bbmt.2015.06.004.
Epub 2015 Jun 11
PMC4568127
Khera N, Majhail NS,
Brazauskas R, Wang Z, He N,
Aljurf MD, Akpek G, Atsuta Y,
Beattie S, Bredeson CN,
Burns LJ, Dalal JD, Freytes
CO, Gupta V, Inamoto Y,
Lazarus HM, LeMaistre CF,
Steinberg A, Szwajcer D,
Wingard JR, Wirk B, Wood
WA, Joffe S, Hahn TE,
Loberiza FR, Anasetti C,
Horowitz MM, Lee SJ
PMC4568172
Page | 105
CIBMTR 2015 Annual Report
APPENDIX D1: SCIENTIFIC WORKING COMMITTEE PUBLICATIONS
SCIENTIFIC WORKING COMMITTEE PUBLICATIONS
Authors
Title
Citation
PMCID
Ayas M, Eapen M, LeRademacher J, Carreras J,
Abdel-Azim H, Alter BP,
Anderlini P, Battiwalla M,
Bierings M, Buchbinder DK,
Bonfim C, Camitta BM, Fasth
AL, Gale RP, Lee MA, Lund
TC, Myers KC, Olsson RF,
Page KM, Prestidge TD, Radhi
M, Shah AJ, Schultz KR, Wirk
B, Wagner JE, Deeg HJ
Shaw BE, Logan BR, Kiefer
DM, Chitphakdithai P,
Pedersen TL, Abdel-Azim H,
Abidi MH, Akpek G, Diaz MA,
Artz AS, Dandoy C, Gajewski
JL, Hematti P, Kamble RT,
Kasow KA, Lazarus HM,
Liesveld JL, Majhail NS,
O'Donnell PV, Olsson RF,
Savani BN, Schears RM,
Stroncek DF, Switzer GE,
Williams EP, Wingard JR,
Wirk BM, Confer DL,
Pulsipher MA
Ciurea SO, Zhang M-J,
Bacigalupo AA, Bashey A,
Appelbaum FR, Aljitawi OS,
Armand P, Antin JH, Chen J,
Devine SM, Fowler DH,
Luznik L, Nakamura R,
O'Donnell PV, Perales M-A,
Pingali SR, Porter DL, Riches
MR, Ringdén OTH, Rocha V,
Vij R, Weisdorf DJ, Champlin
RE, Horowitz MM, Fuchs EJ,
Eapen M
Second allogeneic
hematopoietic cell
transplantation for
patients with Fanconi
anemia and bone marrow
failure
Biology of Blood and
Marrow
Transplantation:
Journal of the
American Society for
Blood and Marrow
Transplantation. 2015
Oct 1; 21(10):17901795. doi:10.1016/
j.bbmt.2015.06.012.
Epub 2015 Jun 23
Biology of Blood and
Marrow
Transplantation:
Journal of the
American Society for
Blood and Marrow
Transplantation. 2015
Oct 1; 21(10):18301838. doi:10.1016/
j.bbmt.2015.06.013.
Epub 2015 Jun 23
PMC4568139
Blood. 2015 Aug 20;
126(8):1033-1040.
doi:10.1182/blood2015-04-639831. Epub
2015 Jun 30
PMC4543223
Analysis of the effect of
race, socioeconomic
status, and center size on
unrelated National
Marrow Donor Program
donor outcomes: donor
toxicities are more
common at low-volume
bone marrow collection
centers
Haploidentical transplant
with posttransplant
cyclophosphamide vs
matched unrelated donor
transplant for acute
myeloid leukemia
PMC4568129
Page | 106
CIBMTR 2015 Annual Report
APPENDIX D1: SCIENTIFIC WORKING COMMITTEE PUBLICATIONS
SCIENTIFIC WORKING COMMITTEE PUBLICATIONS
Authors
Title
Citation
PMCID
Satwani P, Ahn KW, Carreras
J, Abdel-Azim H, Cairo MS,
Cashen A, Chen AI, Cohen JB,
Costa LJ, Dandoy C, Fenske
TS, Freytes CO, Ganguly S,
Gale RP, Ghosh N, Hertzberg
MS, Hayashi RJ, Kamble RT,
Kanate AS, Keating A,
Kharfan-Dabaja MA, Lazarus
HM, Marks DI, Nishihori T,
Olsson RF, Prestidge TD,
Rolon JM, Savani BN, Vose
JM, Wood WA, Inwards DJ,
Bachanova V, Smith SM,
Maloney DG, Sureda A,
Hamadani M
Klyuchnikov E, Bacher U,
Kröger NM, Hari PN, Ahn KW,
Carreras J, Bachanova V,
Bashey A, Cohen JB, D'Souza
A, Freytes CO, Gale RP,
Ganguly S, Hertzberg MS,
Holmberg LA, KharfanDabaja MA, Klein A, Ku GH,
Laport GG, Lazarus HM,
Miller AM, Mussetti A,
Olsson RF, Slavin S, Usmani
SZ, Vij R, Wood WA, Maloney
DG, Sureda AM, Smith SM,
Hamadani M
Petersdorf EW, Malkki M,
O'hUigin C, Carrington M,
Gooley T, Haagenson MD,
Horowitz MM, Spellman SR,
Wang T, Stevenson P
A prognostic model
predicting autologous
transplantation outcomes
in children, adolescents
and young adults with
Hodgkin lymphoma
Bone Marrow
Transplantation. 2015
Nov 1; 50(11):14161423. doi:10.1038/
bmt.2015.177. Epub
2015 Aug 3
PMC4633349
Reduced-intensity
allografting as first
transplantation approach
in relapsed/refractory
grades one and two
follicular lymphoma
provides improved
outcomes in long-term
survivors
Biology of Blood and
Marrow
Transplantation:
Journal of the
American Society for
Blood and Marrow
Transplantation. 2015
Dec 1; 21(12):20912099. doi:10.1016/
j.bbmt.2015.07.028.
Epub 2015 Aug 4
PMC4639453
High HLA-DP expression
and graft-versus-host
disease
PMC4560117
Knight JM, Rizzo JD, Logan
BR, Wang T, Arevalo JM, Ma
J, Cole SW
Low socioeconomic
status, adverse gene
expression profiles, and
clinical outcomes in
hematopoietic stem cell
transplant recipients
New England Journal
of Medicine. 2015 Aug
13; 373(7):599-609.
doi:10.1056/
NEJMoa1500140. Epub
2015 Aug 13
Clinical Cancer
Research. Epub 2015
Aug 18
[PMC Journal
– In Process]
Page | 107
CIBMTR 2015 Annual Report
APPENDIX D1: SCIENTIFIC WORKING COMMITTEE PUBLICATIONS
SCIENTIFIC WORKING COMMITTEE PUBLICATIONS
Authors
Title
Citation
PMCID
Uy GL, Costa LJ, Hari PN,
Zhang M-J, Huang J-X,
Anderson KC, Bredeson CN,
Callander NS, Cornell RF,
Perez MAD, Dispenzieri A,
Freytes CO, Gale RP, Garfall
A, Gertz MA, Gibson J,
Hamadani M, Lazarus HM,
Kalaycio ME, Kamble RT,
Kharfan-Dabaja MA, Krishnan
AY, Kumar SK, Kyle RA,
Landau HJ, Lee CH, Maiolino
A, Marks DI, Mark TM,
Munker R, Nishihori T, Olsson
RF, Ramanathan M,
Rodriguez TE, Saad AA,
Savani BN, Schiller GJ,
Schouten HC, Schriber JR,
Scott E, Seo S, Sharma M,
Ganguly S, Stadtmauer EA,
Tay J, To LB, Vesole DH, Vogl
DT, Wagner JL, Wirk B, Wood
WA, D'Souza A
Burke MJ, Verneris MR, Le
Rademacher J, He W, AbdelAzim H, Abraham AA, Auletta
JJ, Ayas M, Brown VI, Cairo
MS, Chan KW, Diaz Perez
MA, Dvorak CC, Egeler RM,
Eldjerou L, Frangoul H,
Guilcher GMT, Hayashi RJ,
Ibrahim A, Kasow KA, Leung
WH, Olsson RF, Pulsipher
MA, Shah N, Shah NN, Thiel
E, Talano JA, Kitko CL
Contribution of
chemotherapy
mobilization to disease
control in multiple
myeloma treated with
autologous
hematopoietic cell
transplantation
Bone Marrow
Transplantation.
doi:10.1038/
bmt.2015.190. Epub
2015 Aug 24
PMC4548821
Transplant outcomes for
children with T cell acute
lymphoblastic leukemia
in second remission: a
report from the Center
for International Blood
and Marrow Transplant
Research
Biology of Blood and
Marrow
Transplantation:
Journal of the
American Society for
Blood and Marrow
Transplantation. 2015
Dec 1; 21(12):21542159. doi:10.1016/
j.bbmt.2015.08.023.
Epub 2015 Aug 29
PMC4654112
Page | 108
CIBMTR 2015 Annual Report
APPENDIX D1: SCIENTIFIC WORKING COMMITTEE PUBLICATIONS
SCIENTIFIC WORKING COMMITTEE PUBLICATIONS
Authors
Title
Ponce DM, Eapen M,
Sparapani R, O'Brien TA,
Chan KW, Chen J, Craddock J,
Schultz KR, Wagner JE,
Perales M-A, Barker JN
In vivo T cell depletion
with myeloablative
regimens on outcomes
after cord blood
transplantation for acute
lymphoblastic leukemia
in children
Citation
Biology of Blood and
Marrow
Transplantation:
Journal of the
American Society for
Blood and Marrow
Transplantation. 2015
Dec 1; 21(12):21732179. doi:10.1016/
j.bbmt.2015.08.022.
Epub 2015 Aug 29
Pasquini MC, Zhang M-J,
Hematopoietic cell
Biology of Blood and
Medeiros BC, Armand P, Hu
transplantation outcomes Marrow
Z-H, Nishihori T, Aljurf MD,
in monosomal karyotype Transplantation:
Akpek G, Cahn J-Y, Cairo MS, myeloid malignancies
Journal of the
Cerny J, Copelan EA, Deol A,
American Society for
Freytes CO, Gale RP, Ganguly
Blood and Marrow
S, George B, Gupta V, Hale
Transplantation.
GA, Kamble RT, Klumpp TR,
doi:10.1016/
Lazarus HM, Luger SM,
j.bbmt.2015.08.024.
Liesveld JL, Litzow MR, Marks
Epub 2015 Aug 29
DI, Martino R, Norkin M,
Olsson RF, Oran B, Pawarode
A, Pulsipher MA,
Ramanathan M, Reshef R,
Saad AA, Saber W, Savani BN,
Schouten HC, Ringdén O,
Tallman MS, Uy GL, Wood
WA Jr, Wirk B, Pérez WS,
Batiwalla M, Weisdorf DJ
Jindra PT, Conway SE,
Analysis of a genetic
Biology of Blood and
Ricklefs SM, Porcella SF,
polymorphism in the
Marrow
Anzick SL, Haagenson M,
costimulatory molecule
Transplantation:
Wang T, Spellman S, Milford TNFSF4 with HSCT
Journal of the
E, Kraft P, McDermott DH,
outcomes
American Society for
Abdi R
Blood and Marrow
Transplantation.
doi:10.1016/
j.bbmt.2015.08.037.
Epub 2015 Sep 5
PMCID
PMC4639413
[PMC Journal
– In Process]
[PMC Journal
– In Process]
Page | 109
CIBMTR 2015 Annual Report
APPENDIX D1: SCIENTIFIC WORKING COMMITTEE PUBLICATIONS
SCIENTIFIC WORKING COMMITTEE PUBLICATIONS
Authors
Title
Citation
PMCID
D'Souza A, Dispenzieri A,
Wirk B, Zhang M-J, Huang J,
Gertz MA, Kyle RA, Kumar S,
Comenzo RL, Gale RP,
Lazarus HM, Savani BN,
Cornell RF, Weiss BM, Vogl
DT, Freytes CO, Scott EC,
Landau HJ, Moreb JS, Costa
LJ, Ramanathan M, Callander
NS, Kamble RT, Olsson RF,
Ganguly S, Nishihori T,
Kindwall-Keller TL, Wood
WA, Mark TM, Hari P
Ehrhardt MJ, Brazauskas R,
He W, Rizzo JD, Shaw BE
Improved outcomes after
autologous
hematopoietic cell
transplantation for light
chain amyloidosis: a
Center for International
Blood and Marrow
Transplant Research
study
Journal of Clinical
Oncology. 2015 Nov
10; 33(32):3741-3749.
doi:10.1200/JCO.
2015.62.4015. Epub
2015 Sep 14
[PMC Journal
– In Process]
Survival of patients who
develop solid tumors
following hematopoietic
stem cell transplantation
PMC4570237
Klyuchnikov E, Bacher U,
Woo Ahn K, Carreras J,
Kröger NM, Hari PN, Ku GH,
Ayala E, Chen AI, Chen Y-B,
Cohen JB, Freytes CO, Gale
RP, Kamble RT, KharfanDabaja MA, Lazarus HM,
Martino R, Mussetti A, Savani
BN, Schouten HC, Usmani SZ,
Wiernik PH, Wirk B, Smith
SM, Sureda A, Hamadani M
Kollman C, Spellman SR,
Zhang M-J, Hassebroek A,
Anasetti C, Antin JH,
Champlin RE, Confer D,
DiPersio JF, Fernandez-Viña
M, Hartzman RJ, Horowtiz
MM, Hurley CK, Karanes C,
Maiers M, Mueller CR,
Perales M-A, Setterholm M,
Woolfrey AE, Yu N, Eapen M
Long-term survival
outcomes of reducedintensity allogeneic or
autologous
transplantation in
relapsed grade 3
follicular lymphoma
Bone Marrow
Transplantation.
doi:10.1038/bmt.
2015.203. Epub 2015
Sep 14
Bone Marrow
Transplantation.
doi:10.1038/bmt.
2015.223. Epub 2015
Oct 5
Blood.
doi:10.1182/blood2015-08-663823. Epub
2015 Nov 2
[PMC Journal
– In Process]
The effect of donor
characteristics on survival
after unrelated donor
transplantation for
hematologic malignancy
[PMC Journal
– In Process]
Page | 110
CIBMTR 2015 Annual Report
APPENDIX D1: SCIENTIFIC WORKING COMMITTEE PUBLICATIONS
SCIENTIFIC WORKING COMMITTEE PUBLICATIONS
Authors
Title
Citation
PMCID
Riches ML, Trifilio S, Chen M,
Ahn KW, Langston A, Lazarus
HM, Marks DI, Martino R,
Maziarz RT, Papinicolou GA,
Wingard JR, Young J-AH,
Bennett CL
Anthias C, Shaw BE, Kiefer
DM, Liesveld JL, Yared J,
Kamble RT, D'Souza A,
Hematti P, Seftel MD, Norkin
M, DeFilipp ZM, Kasow KA,
Abidi MH, Savani BN, Shah
NN, Anderlini P, Diaz MA,
Malone AK, Halter JP, Lazarus
HM, Logan BR, Switzer GE,
Pulsipher MA, Confer DL,
O'Donnell PV
Kanate AS, Mussetti A,
Kharfan-Dabaja MA, Ahn KW,
DiGilio A, Beitinjaneh A,
Chhabra S, Fenske TS,
Freytes C, Gale RP, Ganguly
S, Hertzberg M, Klyuchnikov
E, Lazarus HM, Olsson R,
Perales M-A, Rezvani A,
Riches M, Saad A, Slavin S,
Smith SM, Sureda A, Yared J,
Ciurea S, Armand P, Salit R,
Bolaños-Meade J, Hamadani
M
Seftel MD, Neuberg D, Zhang
M-J, Wang HL, Ballen KK,
Bergeron J, Couban S,
Freytes CO, Hamadani M,
Kharfan-Dabaja MA, Lazarus
HM, Nishihori T, Paulson K,
Saber W, Sallan SE, Soiffer R,
Tallman MS, Woolfrey AE,
DeAngelo DJ, Weisdorf DJ
Risk factors and impact of
non-Aspergillus mold
infections following
allogeneic HCT: a CIBMTR
infection and immune
reconstitution analysis
Significant improvements
in the practice patterns
of adult related donor
care in US transplant
centers
Bone Marrow
Transplantation.
doi:10.1038/bmt.
2015.263. Epub 2015
Nov 2
[PMC Journal
– In Process]
Biology of Blood and
Marrow
Transplantation:
Journal of the
American Society for
Blood and Marrow
Transplantation.
doi:10.1016/
j.bbmt.2015.11.008.
Epub 2015 Nov 18
[PMC Journal
– In Process]
Reduced-intensity
transplantation for
lymphomas using
haploidentical related
donors versus HLAmatched unrelated
donors
Blood. doi:10.1182/
blood-2015-09671834. Epub 2015
Dec 15
[PMC Journal
– In Process]
Pediatric-inspired
therapy compared to
allografting for
Philadelphia
chromosome negative
adult ALL in first
complete remission
American Journal of
[PMC Journal
Hematology.
– In Process]
doi:10.1002/ajh.24285.
Epub 2015 Dec 23
Page | 111
CIBMTR 2015 Annual Report
APPENDIX D2: BMT CTN PUBLICATIONS
APPENDIX D2: BMT CTN PUBLICATIONS
The following publications were generated by the BMT CTN, a component of the Clinical Trials
Support Program, which conducts multi-institutional Phase II and III trials focused on HCT. The BMT
CTN Data and Coordinating Center maintains continuity of operations and facilitates effective
communications. The Data and Coordinating Center effort is a collaboration of the CIBMTR, NMDP/Be
The Match, and the Emmes Corporation. For more information, see Section 2.3.1.
BMT CTN PUBLICATIONS
Authors
Title
(2014 publication not previously reported)
Levine JE, Braun TM, Harris
A prognostic score for
AC, Holler E, Taylor A, Miller
acute graft-versus-host
H, Magenau J, Weisdorf DJ,
disease based on
Ho VT, Bolaños-Meade J,
biomarkers: a multicentre
Alousi AM, Ferrara JLM
study
MacMillan ML, Robin M,
Harris AC, DeFor TE, Martin
PJ, Alousi A, Ho VT, BolañosMeade J, Ferrara JLM, Jones
R, Arora M, Blazar BR, Holtan
SG, Jacobsohn D, Pasquini M,
Socie G, Antin JH, Levine JE,
Weisdorf DJ
A refined risk score for
acute graft-versus-host
disease that predicts
response to initial
therapy, survival, and
transplant-related
mortality
Holtan SG, Verneris MR,
Schultz KR, Newell LF,
Meyers G, He F, DeFor TE,
Vercellotti GM, Slungaard A,
MacMillan ML, Cooley SA,
Blazar BR, PanoskaltsisMortari A, Weisdorf DJ
Circulating angiogenic
factors associated with
response and survival in
patients with acute graftversus-host disease:
results from Blood and
Marrow Transplant
Clinical Trials Network
0302 and 0802
Citation
PMCID
The Lancet
Haematology.
2(1):e21-e29.
doi:10.1016/S23523026(14)00035-0.
Epub 2014 Dec 23
Biology of Blood and
Marrow
Transplantation:
Journal of the
American Society for
Blood and Marrow
Transplantation. 2015
Apr 1; 21(4):761-767.
doi:10.1016/j.bbmt.
2015.01.001. Epub
2015 Jan 10
Biology of Blood and
Marrow
Transplantation:
Journal of the
American Society for
Blood and Marrow
Transplantation. 2015
Jun 1; 21(6):10291036. doi:10.1016/
j.bbmt.2015.02.018.
Epub 2015 Mar 7
PMC4340092
PMC4359643
PMC4426052
Page | 112
CIBMTR 2015 Annual Report
APPENDIX D2: BMT CTN PUBLICATIONS
BMT CTN PUBLICATIONS
Authors
Title
Citation
PMCID
Khera N, Majhail NS,
Brazauskas R, Wang Z, He N,
Aljurf MD, Akpek G, Atsuta Y,
Beattie S, Bredeson CN,
Burns LJ, Dalal JD, Freytes
CO, Gupta V, Inamoto Y,
Lazarus HM, LeMaistre CF,
Steinberg A, Szwajcer D,
Wingard JR, Wirk B, Wood
WA, Joffe S, Hahn TE,
Loberiza FR, Anasetti C,
Horowitz MM, Lee SJ
Anderlini P, Wu J, Gersten I,
Ewell M, Tolar J, Antin JH,
Adams R, Arai S, Eames G,
Horwitz ME, McCarty J,
Nakamura R, Pulsipher MA,
Rowley S, Leifer E, Carter SL,
DiFronzo NL, Horowitz MM,
Confer D, Deeg HJ, Eapen M
Young JAH, Logan BR, Wu J,
Wingard JR, Weisdorf DJ,
Mudrick C, Knust K, Horowitz
MM, Confer DL, Dubberke
ER, Pergam SA, Marty FM,
Strasfeld LM, Brown JM,
Langston AA, Schuster MG,
Kaul DR, Martin SI, Anasetti C
Comparison of
characteristics and
outcomes of trial
participants and
nonparticipants: example
of Blood and Marrow
Transplant Clinical Trials
Network 0201 trial
Biology of Blood and
Marrow
Transplantation:
Journal of the
American Society for
Blood and Marrow
Transplantation. 2015
Oct 1; 21(10):18151822. doi:10.1016/
j.bbmt.2015.06.004.
Epub 2015 Jun 11
PMC4568172
Cyclophosphamide
conditioning in patients
with severe aplastic
anaemia given unrelated
marrow transplantation:
a phase 1-2 dose deescalation study
Lancet Haematology.
2015 Sep 1; 2(9):e367375. doi:10.1016/
S2352-3026(15)001477. Epub 2015 Sep 2
[PMC Journal
– In Process]
Infections following
transplantation of bone
marrow or peripheralblood stem cells from
unrelated donors
[PMC Journal
– In Process]
Wood WA, Le-Rademacher J,
Syrjala KL, Jim H, Jacobsen
PB, Knight JM, Abidi MH,
Wingard JR, Majhail NS,
Geller NL, Rizzo JD, Fei M,
Wu J, Horowitz MM, Lee SJ
Patient-reported physical
functioning predicts the
success of hematopoietic
cell transplantation (BMT
CTN 0902)
Biology of Blood and
Marrow
Transplantation:
Journal of the
American Society for
Blood and Marrow
Transplantation.
doi:10.1016/
j.bbmt.2015.09.013.
Epub 2015 Sep 23
Cancer. doi: 10.1002/
cncr.29717. Epub 2015
Oct 6
[PMC Journal
– In Process]
Page | 113
CIBMTR 2015 Annual Report
APPENDIX D2: BMT CTN PUBLICATIONS
BMT CTN PUBLICATIONS
Authors
Title
Citation
PMCID
Giralt S, Garderet L, Durie B,
Cook G, Gahrton G, Bruno B,
Hari P, Lokhorst H, McCarthy
P, Krishnan A, Sonneveld P,
Goldschmidt H, Jagannath S,
Barlogie B, Mateos M,
Gimsing P, Sezer O, Mikhael
J, Jin L, Dimopoulos M,
Mazumder A, Palumbo A,
Abonour R, Anderson K, Attal
M, Blade J, Bird J, Cavo M,
Comenzo R, de la Rubia J,
Einsele H, Sanz RG, Hillengass
J, Holstein S, Johnsen H,
Joshua D, Koehne G, Kumar
S, Kyle R, Leleu X, Lonial S,
Ludwig H, Nahi H, Nooka A,
Orlowski R, Rajkumar V,
Reiman A, Richardson P,
Rivas E, San Miguel J,
Turreson I, Usmani S, Vesole
D, Bensinger W, Qazilbash M,
Efebera Y, Mohty M,
Gasparreto C, Gajewski J,
LeMaistre C, Bredeson C,
Moreau P, Pasquini M,
Kroeger N, Stadtmauer E
Devine SM, Owzar K, Blum
W, Mulkey F, Stone RM, Hsu
JW, Champlin RE, Chen Y-B,
Vij R, Slack J, Soiffer RJ,
Larson RA, Shea TC, Hars V,
Sibley AB, Geralt S, Carter S,
Horowitz MM, Linker C, Alyea
EP
American Society of
Blood and Marrow
Transplant, European
Society of Blood and
Marrow Transplantation,
Blood and Marrow
Transplant Clinical Trials
Network and
International Myeloma
Working Group
Consensus Conference on
Salvage Hematopoietic
Cell Transplantation in
Patients with Relapsed
Multiple Myeloma
Biology of Blood and
Marrow
Transplantation. 2015
Dec 1; 21(12):20392051. doi: 10.1016/
j.bbmt.2015.09.016.
Epub 2015 Sep 30
[PMC Journal
– In Process]
Phase II study of
Journal of Clinical
allogeneic transplantation Oncology. Epub 2015
for older patients with
Nov 2
acute myeloid leukemia
in first complete
remission using a
reduced-intensity
conditioning regimen:
results from cancer and
leukemia group B 100103
(alliance for clinical trials
in oncology)/blood and
marrow transplant clinical
trial network 0502
[PMC Journal
– In Process]
Page | 114
CIBMTR 2015 Annual Report
APPENDIX D3: HEALTH SERVICES RESEARCH PROGRAM PUBLICATIONS
APPENDIX D3: HEALTH SERVICES RESEARCH PROGRAM PUBLICATIONS
The following publications were generated by the Health Services Research program, through which
the CIBMTR conducts research in health disparities, health policy, and system capacity issues
involving HCT. For more information, see Section 2.4.
HEALTH SERVICES RESEARCH PROGRAM PUBLICATIONS
Authors
Title
Besse KL, Preussler JM,
Murphy EA, Denzen EM, Lill
MC, Chell JW, Senneka MK,
Majhail NS, Williams EP
Estimating demand and
unmet need for allogeneic
hematopoietic cell
transplantation in the
United States using
geographic information
systems
Majhail NS, Mau L-W,
National survey of
Chitphakdithai P, Payton T,
hematopoietic cell
Eckrich M, Joffe S, Lee SJ,
transplantation center
LeMaistre CF, LeRademacher personnel, infrastructure,
J, Loberiza F, Logan B, Parsons and models of care
SK, Repaczki-Jones R, Robinett delivery
P, Rizzo JD, Murphy E, Denzen
EM
Clauser SB, Gayer C, Murphy
E, Majhail NS, Baker KS
Patient centeredness and
engagement in quality-ofcare oncology research
Preussler JM, Mau L-W,
Majhail NS, Bevans M, Clancy
E, Messner C, Parran L,
Pederson KA, Ferguson SS,
Walters W, Murphy EA,
Denzen EM
Patient housing barriers
to hematopoietic cell
transplantation: results
from a mixed-methods
study of transplant center
social workers
Citation
PMCID
Journal of Oncology
Practice. 11(2):e120e130. doi:10.1200/
JOP.2014.000794.
Epub 2015 Mar 1
PMC4371120
Biology of Blood and
Marrow
Transplantation:
Journal of the
American Society for
Blood and Marrow
Transplantation. 2015
Jul 1; 21(7):13081314. doi:10.1016/
j.bbmt.2015.03.020.
Epub 2015 Mar 31
Journal of Oncology
Practice. 2015 May 1;
11(3):176-179.
doi:10.1200/JOP.2015
.003749. Epub 2015
Apr 7
Supportive Care in
Cancer. doi:10.1007/
s00520-015-2872-9.
Epub 2015 Aug 15
PMC4466059
[PMC Journal
– In Process]
[PMC Journal
– In Process]
Page | 115
CIBMTR 2015 Annual Report
APPENDIX D4: BIOINFORMATICS RESEARCH PROGRAM PUBLICATIONS
APPENDIX D4: BIOINFORMATICS RESEARCH PROGRAM PUBLICATIONS
The following publications were generated by the Bioinformatics Research Program, which provides
expertise in, and conducts research on, translational and operational bioinformatics. For more
information, see Section 2.5.
BIOINFORMATICS RESEARCH PROGRAM PUBLICATIONS
Authors
Title
Citation
PMCID
Besse KL, Preussler JM,
Murphy EA, Denzen EM, Lill
MC, Chell JW, Senneka MK,
Majhail NS, Williams EP
Estimating demand and
unmet need for allogeneic
hematopoietic cell
transplantation in the
United States using
geographic information
systems
Power laws for heavytailed distributions:
modeling allele and
haplotype diversity for
the National Marrow
Donor Program
Progress toward curing
HIV infection with
hematopoietic cell
transplantation
Journal of Oncology
Practice. 11(2):e120e130. doi:10.1200/
JOP.2014.000794.
Epub 2015 Mar 1
PMC4371120
PLoS Computational
Biology.
11(4):e1004204.
doi:10.1371/journal.p
cbi.1004204. Epub
2015 Apr 22
Stem Cells and
Cloning: Advances
and Applications.
2015(8):109-116.
doi:10.2147/SCCAA.S
56050. Epub 2015 Jul
28
PLoS One.
doi:10.1371/journal.p
one.0135960. Epub
2015 Aug 19
PMC4406525
Slater N, Louzoun Y, Gragert
L, Maiers M, Chatterjee A,
Albrecht M
Petz LD, Burnett JC, Li H, Li S,
Tonai R, Bakalinskaya M,
Shpall EJ, Armitage S,
Kurtzberg J, Regan DM, Clark
P, Querol S, Gutman JA,
Spellman SR, Gragert L, Rossi
JJ
Hollenbach JA, Saperstein A,
Albrecht M, Vierra-Green C,
Parham P, Norman PJ, Maiers
M
Race, ethnicity and
ancestry in unrelated
transplant matching for
the National Marrow
Donor Program: a
comparison of multiple
forms of selfidentification with
genetics
PMC4524463
PMC4545604
Page | 116
CIBMTR 2015 Annual Report
APPENDIX D4: BIOINFORMATICS RESEARCH PROGRAM PUBLICATIONS
BIOINFORMATICS RESEARCH PROGRAM PUBLICATIONS
Authors
Title
Citation
PMCID
Besse K, Maiers M, Confer D,
Albrecht M
On modeling HLAidentical sibling match
probability for alloHCT:
estimating the need for
an unrelated donor
source
N/A
Single RM, Strayer N,
Thomson G, Paunic V,
Albrecht M, Maiers M
Asymmetric linkage
disequilibrium: tools for
assessing multiallelic LD
Mack SJ, Milius RP, Gifford
BD, Sauter J, Hofmann J,
Osoegawa K, Robinson J,
Groeneweg M, Turenchalk
GS, Adai A, Holcomb C,
Rozemuller EH, Penning MT,
Heuer ML, Wang C, Salit ML,
Schmidt AH, Parham PR,
Müller C, Hague T, Fischer G,
Fernandez-Viña M,
Hollenbach JA, Norman PJ,
Maiers M
Magalon J, Maiers M,
Kurtzberg J, Navarrete C,
Rubinstein P, Brown C,
Schramm C, Larghero J,
Katsahian S, Chabannon C,
Picard C, Platz A, Schmidt A,
Katz G
Minimum information for
reporting next generation
sequence genotyping
(MIRING): guidelines for
reporting HLA and KIR
genotyping via next
generation sequencing
Biology of Blood and
Marrow
Transplantation:
Journal of the
American Society for
Blood and Marrow
Transplantation.
doi:10.1016/j.bbmt.2
015.09.012. Epub
2015 Sep 5
Human Immunology.
doi:10.1016/j.humim
m.2015.09.001. Epub
2015 Sep 7
Human Immunology.
doi:10.1016/j.humim
m.2015.09.011. Epub
2015 Sep 25
PLoS One.
10(12):e0143440.
Epub 2015 Dec 1
PMC4666404
Banking or bankrupting:
strategies for sustaining
the economic future of
public cord blood banks
N/A
[PMC Journal
– In Process]
Page | 117
CIBMTR 2015 Annual Report
APPENDIX D4: BIOINFORMATICS RESEARCH PROGRAM PUBLICATIONS
BIOINFORMATICS RESEARCH PROGRAM PUBLICATIONS
Authors
Title
Citation
PMCID
Buck K, Wadsworth K,
Setterholm M, Maiers M,
Confer D, Hartzman R,
Schmidt A, Yang SY, Dehn J
7/8 and 9/10 or better
high resolution match
rate for the Be The
Match® Unrelated Donor
Registry
Biology of Blood and
Marrow
Transplantation:
Journal of the
American Society for
Blood and Marrow
Transplantation.
doi:10.1016/j.bbmt.2
015.12.012. Epub
2015 Dec 24
N/A
Page | 118
CIBMTR 2015 Annual Report
APPENDIX D5: STATISTICAL METHODOLOGY RESEARCH PROGRAM PUBLICATIONS
APPENDIX D5: STATISTICAL METHODOLOGY RESEARCH PROGRAM
PUBLICATIONS
The following publications were generated by the Statistical Methodology Research Program, which
develops and evaluates the statistical models used in HCT. For more information, see Section 2.6.
STATISTICAL METHODOLOGY RESEARCH PROGRAM PUBLICATIONS
Authors
Title
Citation
PMCID
Keiding N, Andersen
PK, Zhang MJ
Editorial: To the
memory of John P.
Klein
N/A
Wang T, He P, Ahn KW,
Wang X, Ghosh S, Laud
P
A re-formulation of
generalized linear
mixed models to fit
family data in genetic
association studies
The proportional odds
cumulative incidence
model for competing
risks
A proportional
hazards regression
model for the
subdistribution with
covariates-adjusted
censoring weight for
competing risks data
Observational studies:
matching or
regression?
Lifetime Data Analysis. 2015 Apr
1; 21(2):157-159. doi:10.1007/
s10985-015-9320-5. Epub 2015
Feb 7
Frontiers in Genetics. 6(120):110. doi:10.3389/
fgene.2015.00120. Epub 2015
Mar 31
Biometrics. 2015 Sep 1;
71(3):687-695.
doi:10.1111/biom.12330. Epub
2015 May 26
Scandinavian Journal of
Statistics, Theory and
Applications.
doi:10.1111/sjos.12167. Epub
2015 Jun 5
PMC4608382
Eriksson F, Li J, Scheike
T, Zhang M-J
He P, Eriksson F,
Scheike TH, Zhang M-J
Brazauskas R, Logan BR
PMC4379931
[PMC Journal
– In Process]
Biology of Blood and Marrow
[PMC Journal
Transplantation: Journal of the
– In Process]
American Society for Blood and
Marrow Transplantation.
doi:10.1016/j.bbmt.2015.12.005.
Epub 2015 Dec 19
Page | 119
CIBMTR 2015 Annual Report
APPENDIX D6: COORDINATING CENTER PUBLICATIONS
APPENDIX D6: COORDINATING CENTER PUBLICATIONS
The following publications incorporated major contributions from the CIBMTR Coordinating Center
and Scientific Directors.
COORDINATING CENTER PUBLICATIONS
Authors
Title
Citation
PMCID
Majhail NS, Giralt S, Bonagura
A, Crawford S, Farnia S, Omel
JL, Pasquini M, Saber W,
LeMaistre CF
Guidelines for defining
and implementing
standard episode of care
for hematopoietic stem
cell transplantation
within the context of
clinical trials
Biology of Blood and
Marrow
Transplantation:
Journal of the
American Society for
Blood and Marrow
Transplantation. 2015
Apr 1; 21(4):583-588.
doi:10.1016/
j.bbmt.2014.12.030.
Epub 2015 Jan 29
Current Hematologic
Malignancy Reports.
2015 Mar 1; 10(1):4558. doi:10.1007/
s11899-014-0246-x.
Epub 2015 Feb 21
The Lancet
Haematology.
2(3):e91-e100.
doi:10.1016/S23523026(15)00028-9.
Epub 2015 Mar 1
N/A
Sucheston-Campbell LE, Clay
A, McCarthy PL, Zhu Q, Preus
L, Pasquini M, Onel K, Hahn T
Identification and
utilization of donor and
recipient genetic variants
to predict survival after
HCT: are we ready for
primetime?
Gratwohl A, Pasquini MC,
One million haemopoietic
Aljurf M, Atsuta Y, Baldomero stem-cell transplants: a
H, Foeken L, Gratwohl M,
retrospective
Bouzas LF, Confer D,
observational study
Frauendorfer K, Gluckman E,
Greinix H, Horowitz M, Iida
M, Lipton J, Madrigal A,
Mohty M, Noel L, Novitzky N,
Nunez J, Oudshoorn M,
Passweg J, van Rood J, Szer J,
Blume K, Appelbaum F,
Kodera Y, Niederwieser D
PMC4352187
N/A
Page | 120
CIBMTR 2015 Annual Report
APPENDIX D6: COORDINATING CENTER PUBLICATIONS
COORDINATING CENTER PUBLICATIONS
Authors
Title
Citation
PMCID
Shah N, Callander N, Ganguly
S, Gul Z, Hamadani M, Costa
L, Sengsayadeth S, Abidi M,
Hari P, Mohty M, Chen Y-B,
Koreth J, Landau H, Lazarus
H, Leather H, Majhail N, Nath
R, Osman K, Perales M-A,
Schriber J, Shaughnessy P,
Vesole D, Vij R, Wingard J,
Giralt S, Savani BN
Hematopoietic stem cell
transplantation for
multiple myeloma:
guidelines from the
American Society for
Blood and Marrow
Transplantation
[PMC Journal
– In Process]
Eapen M
Hematopoietic cell
transplantation for acute
leukemia: selecting
donors
Khera N
From evidence to clinical
practice in blood and
marrow transplantation
Biology of Blood and
Marrow
Transplantation:
Journal of the
American Society for
Blood and Marrow
Transplantation. 2015
Jul 1; 21(7):1155-1166.
doi:10.1016/j.bbmt.
2015.03.002. Epub
2015 Mar 11
Haematologica. 2015
Apr 1; 100(4):414-415.
doi:10.3324/haematol.
2015.124974. Epub
2015 Apr 1
Blood Reviews.
doi:10.1016/j.blre.
2015.04.001. Epub
2015 Apr 9
Graff TM, Singavi AK, Schmidt
W, Eastwood D, Drobyski WR,
Horowitz M, Palmer J,
Pasquini M, Rizzo DJ, Saber
W, Hari P, Fenske TS
Safety of outpatient
autologous
hematopoietic cell
transplantation for
multiple myeloma and
lymphoma
National Institutes of
Health Consensus
Development Project on
Criteria for Clinical Trials
in Chronic Graft-versusHost Disease: VI. The
2014 Clinical Trial Design
Working Group Report
Bone Marrow
Transplantation. 2015
Jul 1; 50(7):947-953.
doi:10.1038/
bmt.2015.46. Epub
2015 Apr 13
Biology of Blood and
Marrow
Transplantation:
Journal of the
American Society for
Blood and Marrow
Transplantation. 2015
Aug 1; 21(8):13431359. doi:10.1016/
j.bbmt.2015.05.004.
Epub 2015 May 15
PMC4490016
Martin PJ, Lee SJ, Przepiorka
D, Horowitz MM, Koreth J,
Vogelsang GB, Walker I,
Carpenter PA, Griffith LM,
Akpek G, Mohty M, Wolff D,
Pavletic SZ, Cutler CS
PMC4380712
PMC4610823
PMC4506719
Page | 121
CIBMTR 2015 Annual Report
APPENDIX D6: COORDINATING CENTER PUBLICATIONS
COORDINATING CENTER PUBLICATIONS
Authors
Title
Gale RP, Eapen M
Who is the best
alternative allotransplant
donor?
Renner R, Carlis J, Maiers M,
Rizzo JD, O'Neill C, Horowitz
M, Gee K, Confer D
Booth GS, Gehrie EA, Jagasia
MH, Shaw BE, Savani BN
Majhail NS, Farnia SH,
Carpenter PA, Champlin RE,
Crawford S, Marks DI, Omel
JL, Orchard PJ, Palmer J,
Saber W, Savani BN, Veys PA,
Bredeson CN, Giralt SA,
LeMaistre CF
Deeg HJ, Bredeson C, Farnia
S, Ballen K, Gupta V, Mesa
RA, Popat U, Hari P, Saber W,
Seftel M, Tamari R,
Petersdorf EW
Citation
Bone Marrow
Transplantation. 2015
Jun 1; 50(S2):S40-S42.
doi:10.1038/
bmt.2015.94. Epub
2015 Jun 4
Integration of
Data Integration in the
hematopoietic cell
Life Sciences. 2015 Jul
transplantation outcomes 8; 9162:139-146.
data: data standards are
doi:10.1007/978-3not enough
319-21843-4_11
When can you discard
Biology of Blood and
stem cells?
Marrow
Transplantation:
Journal of the
American Society for
Blood and Marrow
Transplantation.
doi:10.1016/j.bbmt.
2015.07.024. Epub
2015 Aug 4
Indications for autologous Biology of Blood and
and allogeneic
Marrow
hematopoietic cell
Transplantation:
transplantation:
Journal of the
guidelines from the
American Society for
American Society for
Blood and Marrow
Blood and Marrow
Transplantation.
Transplantation
doi:10.1016/j.bbmt.
2015.07.032. Epub
2015 Aug 7
Hematopoietic cell
Biology of Blood and
transplantation as
Marrow
curative therapy for
Transplantation:
patients with
Journal of the
myelofibrosis: long-term
American Society for
success in all age groups
Blood and Marrow
Transplantation. 2015
Nov 1; 21(11):18831887. doi:10.1016/
j.bbmt.2015.09.005.
Epub 2015 Sep 11
PMCID
PMC4520408
N/A
N/A
N/A
PMC4604067
Page | 122
CIBMTR 2015 Annual Report
APPENDIX D6: COORDINATING CENTER PUBLICATIONS
COORDINATING CENTER PUBLICATIONS
Authors
Title
Citation
PMCID
Pagliuca S, Gérard L,
Kulasekararaj A, Eapen M,
Boutboul D, Martin H, Salvino
MA, Knol-Bout C, Dufour C,
Peffault de Latour R, Marsh J
Characteristics and
outcomes of aplastic
anemia in HIV patients: a
brief report from the
severe aplastic anemia
working party of the
European Society of
Blood and Bone Marrow
Transplantation
Bone Marrow
Transplantation.
doi:10.1038/
bmt.2015.252. Epub
2015 Oct 19
N/A
Page | 123
CIBMTR 2015 Annual Report
APPENDIX E: PRESENTATIONS
APPENDIX E: PRESENTATIONS
2015 AMERICAN SOCIETY OF HEMATOLOGY (ASH) ANNUAL MEETING
Study
Title
Type
PI
BMT CTN
0201
5 year results of BMT CTN 0201: unrelated donor bone
marrow is associated with better psychological well-being and
less burdensome chronic graft-versus-host disease symptoms
than peripheral blood
* Selected as a 2016 Highlight of ASH
Oral
SJ Lee
BMT CTN
0601
A multicenter Phase II trial of unrelated donor reduced
intensity bone marrow transplantation for children with
severe sickle cell disease (SCURT): Results of the Blood and
Marrow Transplant Clinical Trials Network (BMT CTN 0601)
Study
Oral
S Shenoy
BMT CTN
0805
Multicenter US intergroup study of intensive chemotherapy
plus dasatinib followed by allogeneic stem cell transplant in
patients with Philadelphia chromosome positive acute
lymphoblastic leukemia younger than 60
* Late Breaking Abstract
Oral
F Ravandi
BMT CTN
0901
Results of a Phase III randomized, multi-center study of
allogeneic stem cell transplantation after high vs reduced
intensity conditioning in patients with myelodysplastic
syndrome or acute myeloid leukemia
* Late Breaking Abstract
Oral
BL Scott
CK11-02
A prognostic system predictive of outcomes in persons
undergoing allogeneic hematopoietic cell transplantation for
myelodysplastic syndrome
Oral
B Shaffer
CK14-01
Outcomes after umbilical cord blood transplantation for
myelodysplastic syndromes: a Center for International Blood
and Marrow Transplant Registry study
Poster
A Gerds
GV12-01
Outcomes of grades II-IV acute graft-versus-host disease post
allogeneic hematopoietic stem cell transplantation: How
much progress was achieved?
Poster
H Khoury
GV12-02
Upper gastrointestinal acute graft-versus-host disease adds
minimal prognostic value when present in isolation or in
addition to grade I or other grade II-defining GvHD
manifestations
Oral
S Nikiforow
Page | 124
CIBMTR 2015 Annual Report
APPENDIX E: PRESENTATIONS
2015 AMERICAN SOCIETY OF HEMATOLOGY (ASH) ANNUAL MEETING
Study
Title
Type
PI
HS13-01
The impact of pre-transplant depression on outcomes of
allogeneic and autologous hematopoietic stem cell
transplantation
Oral
A El-Jawahri
HS13-02
A study of predictors of clinical outcomes and healthcare
utilization in children with sickle cell disease undergoing
allogeneic hematopoietic cell transplantation
Oral
S Arnold
IB11-01
Evaluation of the impact of non-inherited maternal antigens
on the outcome of HLA mismatched unrelated donor
hematopoietic stem cell transplantation for hematological
malignancies on behalf of the ALWP of the EBMT and the
CIBMTR
Poster
J Pingel
IB12-03
Investigating effect of genetic admixture and donor / recipient
genetic disparity on transplant outcomes
Poster
A Madbouly
LK13-04
Comparison of post allogeneic hematopoietic cell
transplantation outcomes after matched related donor versus
matched unrelated donor HCT in adults with acute
lymphoblastic leukemia
Poster
E Segal
LK14-02
Outcomes of allogeneic transplantation in patients aged ≤ 60
years with acute myeloid leukemia in second complete
remission: a CIBMTR cohort analysis
Poster
F Michelis
LK14-03
Autologous transplant, and not ATO alone, remains the
preferred therapy for relapsed APL: a report from the
CIBMTR, EBMT, and two specialized centers
Oral
M Tallman
LY06-03
Allogeneic stem cell transplantation for relapsed / refractory
follicular lymphoma: a joint study between the European
Society for Blood and Marrow Transplantation and the Center
for International Blood and Marrow Transplant Research
Oral
A Sureda
LY14-02
Reduced-intensity allogeneic hematopoietic cell
transplantation provides durable progression-free survival in
a subset of diffuse large B-cell lymphoma patients relapsing
after autologous HCT
Oral
T Fenske
Page | 125
CIBMTR 2015 Annual Report
APPENDIX E: PRESENTATIONS
2015 AMERICAN SOCIETY OF HEMATOLOGY (ASH) ANNUAL MEETING
Study
LY15-01
Title
Type
PI
Survival after T-cell replete haploidentical related donor
transplant using post-transplant cyclophosphamide compared
with matched unrelated donor transplant for lymphoid
malignancies
* Selected as a 2016 Highlight of ASH
Oral
M KharafanDabaja
Poster
M Sharma
MM13-02
Autologous hematopoietic cell transplantation in patients
with high risk multiple myeloma: post-transplant responses
do not translate to longer survival
MM15-01
Post transplant therapy is more important than induction
regimen choice in autologous hematopoietic cell
transplantation recipients for multiple myeloma
Oral
R Cornell
RCI BMT
09PLEX
A Phase II study evaluating the safety and efficacy of
subcutaneous plerixafor for the mobilization and
transplantation of HLA-matched sibling donor hematopoietic
stem cells in recipients with hematologic malignancies
Oral
S Devine
RT09-04 /
IB09-06
Combined donor and recipient non-HLA genotypes show
evidence of genome-wide association with transplant related
mortality after HLA-matched unrelated donor blood and
marrow transplantation (DISCOVeRY BMT Study)
Oral
L SuchestonCampbell
RT09-04 /
IB09-06
Genome wide association study of overall and progressionfree survival after HLA-matched unrelated donor blood and
marrow transplantation (DISCOVeRY BMT Study)
Oral
T Hahn
RT09-04c
Evidence for heterogeneous genetic associations with acute
lymphoblastic leukemia by cytogenetics and sex in high risk
patients treated with matched unrelated donor allogeneic
blood or marrow transplant
Poster
A Clay
SC11-06
Outcome of patients 65 years and older with myelodysplastic
syndrome receiving allogeneic hematopoietic stem cell
transplantation compared to patients 55-64 years of age
Oral
E Atallah
Page | 126
CIBMTR 2015 Annual Report
APPENDIX E: PRESENTATIONS
2015 BMT TANDEM MEETINGS
Type
Principal
Investigator
BioMetadata / BRIDG integration process
informatics
Oral
J Pollack
BioStem cell transplant interoperability using BRIDG
informatics
Oral
RP Milius
Study
Title
BMT CTN
More infections with transplantation of bone marrow versus
peripheral-blood stem cells from unrelated donors
Oral
J Young
BMT CTN
0302 /
0802
Prognostic impact of follistatin in acute graft-versus-host
disease: results from BMT CTN 0302 and 0802
Oral
S Holtan
CK13-02
Allogeneic hematopoietic cell transplantation for adult
chronic myelomonocytic leukemia
Oral
H Duong
DS05-02b
& RCI BMT
06-DON
Health-related quality of life among older adult related
hematopoietic stem cells donors (>60 yrs.) is equivalent to or
better than that of younger adult related donors (18-60 yrs.)
Oral
G Switzer
DS05-02c /
RCI BMT
06-DON
Acute toxicities of related adult donors compared to
unrelated adult
Oral
M Pulsipher
DS09-04
The effect of race, socioeconomic status, and collection
center size on bone marrow and peripheral blood stem cell
donor experiences at National Marrow Donor Program
collection centers
Oral
M Pulsipher
HS13-03
Clinical outcomes among unrelated donor transplant
recipients for acute myelogenous leukemia as a function of
socioeconomic status and related transcriptome differences
Oral
J Knight
HSR 13-01
Administrative claims data for cost analyses in hematopoietic
cell transplantation: the good, the bad and the ugly
Poster
J Preussler
HSR 13-02
Patient and provider preferences for survivorship care plans
for allogenic hematopoietic cell transplantation survivors: a
qualitative study
Poster
E Murphy
HSR 14-02
Hematopoietic cell transplantation multidisciplinary care
teams: burnout, moral distress and career satisfaction
Poster
J Neumann
Page | 127
CIBMTR 2015 Annual Report
APPENDIX E: PRESENTATIONS
2015 BMT TANDEM MEETINGS
Study
Title
Type
Principal
Investigator
IB13-05
MHC class I chain-related gene A (MICA) donor-recipient
mismatches and MICA-129 polymorphism in unrelated donor
hematopoietic stem cell transplants for hematological
malignancies: a CIBMTR study
Poster
M Askar
IS13-01
Impact of race on graft-versus-host disease rates after HLAmatched sibling bone marrow or peripheral blood
hematopoietic cell transplantation: Comparison of North
American Caucasian versus Japanese populations
Oral
J Kanda
LK13-03
Allogeneic transplant for acute biphenotypic leukemia:
characteristics and outcome in the CIBMTR database
Oral
R Munker
LY12-01
Positive pre-allogeneic hematopoietic cell transplantation
PET scan in patients with non-Hodgkin lymphoma predicts
higher risk of relapse but has no impact on survival
Oral
V Bachanova
LY13-02
Risk factors predicting outcomes of autologous
hematopoietic cell transplantation in children, adolescents
and young adults with relapsed / refractory classical Hodgkin
lymphoma: a CIBMTR analysis
Oral
P Satwani
2015 AMERICAN SOCIETY OF CLINICAL ONCOLOGY ANNUAL MEETING
Title
Type
Principal
Investigator
LY13-03
Reduced intensity conditioning allograft as first transplant
approach in relapsed / refractory grade III follicular
lymphoma is associated with improved outcomes in longterm survivors
Oral
E
Klyuchnikov
BMT CTN
0704
Updated analysis of CALGB / ECOG / BMT CTN 100104:
Lenalidomide vs. placebo maintenance therapy after single
autologous stem cell transplant for multiple myeloma
Poster
SA Holstein
Study
Page | 128
CIBMTR 2015 Annual Report
APPENDIX E: PRESENTATIONS
2015 EUROPEAN GROUP FOR BLOOD AND MARROW TRANSPLANTATION (EBMT)
ANNUAL MEETING
Type
Principal
Investigator
BioReporting NGS-based HLA & KIR genotyping using MIRING
informatics
principles
HML 1.0
Oral
RP Milius
DS05-02f /
RCI BMT
06-DON
Health-related quality of life among pediatric hematopoietic
stem cell donors
Oral
G Switzer
DS14-01
(US)
Significant improvements in the practice patterns of related
donor care in US transplant centres
Poster
C Anthias
DS14-01
(EBMT)
JACIE accreditation significantly improves compliance with
international recommendations for related donor care in
EBMT transplant centres
Poster
C Anthias
IB12-02b
Uni-directional and bi-directional non-permissive HLA-DPB1 T
cell epitope group mismatches have similar risk associations
in 10/10 matched unrelated donor HCT
Oral
K
Fleischhauer
IB12-04b
Effect of HLA-C allele matching in the context of patients
HLA-C encoded KIR ligand grouping (C1 or C2) on outcomes
of unrelated hematopoietic stem cell transplantation
Oral
J Fischer
IB12-06
KIR B genotype in HLA-matched unrelated donor protects
from relapse and improves progression-free survival after
allogeneic transplantation for relapsed / refractory nonHodgkin lymphoma
(This presentation was withdrawn because the PI was unable
to attend the meeting)
Poster
V Bachanova
Study
Title
2015 EUROPEAN HEMATOLOGY ASSOCIATION CONGRESS
Title
Type
Principal
Investigator
LY13-03
Reduced intensity conditioning allo transplantation is
associated with superior long-term disease control in
relapsed / refractory grade I/II follicular lymphoma
Oral
E
Klyuchnikov
BMT CTN
0102
Heavy light chain ratio normalization allows identification of
electrophoretic non-complete response patients with
improved outcomes: a long term follow up update for BMT
CTN 0102 correlative study
Poster
A D’Souza
Study
Page | 129
CIBMTR 2015 Annual Report
APPENDIX E: PRESENTATIONS
2015 EUROPEAN IMMUNOGENETICS AND HISTOCOMPATIBILITY CONFERENCE
Type
Principal
Investigator
BioUsing SNPs to improve phasing of HLA haplotypes
informatics
Oral
V Paunic
BioImpudigree: an imputation-based automated pedigree tool
informatics
Oral
J Freeman
BioImproved HLA-based race / ethnic classification using donor
informatics geography and census demographic data
Poster
L Gragert
BioHLA diversity in the Ezer Mizion Registry
informatics
Poster
M Halagan
HLA class II six-locus DRB3/4/5~DRB1~DQA1~DQB1~DPA1~
BioDPB1 high resolution haplotype frequencies of the major US
informatics
populations
Poster
M Halagan
BioHLA allele and haplotype frequencies for Christian and
informatics Muslim Arab donors in Hadassah Registry
Poster
A Bishara
Study
Title
2015 INSTITUTE FOR HEALTHCARE ADVANCEMENT’S ANNUAL HEALTH LITERACY
CONFERENCE
Study
BMT CTN
1205
Title
Type
Principal
Investigator
Easy-to-read informed consent forms for multi-center
hematopoietic cell transplant clinical trials
Poster
H Moore
2015 INTERNATIONAL CONFERENCE ON LONG-TERM COMPLICATIONS OF TREATMENT
OF CHILDREN AND ADOLESCENTS FOR CANCER
Study
LE13-04
Title
Type
Principal
Investigator
Survival of patients who develop solid tumors following
hematopoietic stem cell transplantation
Poster
M Ehrhardt
Page | 130
CIBMTR 2015 Annual Report
APPENDIX E: PRESENTATIONS
2015 PEDIATRIC BLOOD AND MARROW TRANSPLANT CONSORTIUM ANNUAL
MEETING
Study
LE13-04
Title
Type
Principal
Investigator
Survival of patients who develop solid tumors following
hematopoietic stem cell transplantation
Oral
M Ehrhardt
2015 WORLD CONGRESS OF PSYCHO-ONCOLOGY
(hosted by the International Psycho-Oncology Society and
American Psychosocial Oncology Society)
Title
Type
Principal
Investigator
BMT CTN
0902
Cancer and treatment distress measurement over time in a
multicenter cohort of hematopoietic cell transplantation
recipients
Oral
K Syrjala
BMT CTN
0902
Pre-transplant health-related quality of life factors as
predictors of outcomes following hematopoietic cell
transplantation
Oral
J Knight
Study
2015 WORLD MARROW DONOR ASSOCIATION MEETING
Type
Principal
Investigator
BioKey driver analysis of HLA diversity: analytically focused
informatics recruitment strategies for improving registry quality
Poster
A
Sivasankaran
BioEnhancing HML for electronic reporting of NGS-based HLA
informatics and KIR genotyping results
Poster
J Kathryn
Study
Title
Page | 131
CIBMTR 2015 Annual Report
APPENDIX F: STUDY DEVELOPMENT AND MANAGEMENT PROCESS
APPENDIX F: STUDY DEVELOPMENT AND MANAGEMENT PROCESS
This study development and management process pertains to studies for which the CIBMTR provides
data and statistical support. Data sets are also made available to investigators who have their own
statistical resources. Final analyses and manuscripts resulting from these analyses are reviewed and
approved by the CIBMTR prior to journal submission.
STUDY DEVELOPMENT AND MANAGEMENT PROCESS
Planned
Protocol pending. Proposals remain in this preliminary stage until the PI creates a
draft protocol.
Draft protocol received. When a PI submits a draft protocol, Coordinating Center
staff review it.
Protocol development. During the development process, the Working Committee
biostatisticians, Scientific Director, and Chairs refine the submission into a
comprehensive study protocol. They add a table with a preliminary description of
the proposed study population and present the draft protocol for discussion at a
weekly Coordinating Center statistical meeting. When a protocol is approved,
Coordinating Center personnel invite Working Committee members to participate
in a Writing Committee.
In Progress
Sample typing. If applicable, the PIs perform laboratory tests (e.g., genotyping) on
samples from the CIBMTR Research Repository. The testing data will be used in
the analysis to determine any correlation with clinical outcome.
Supplemental forms / data collection. Most studies use routinely-collected data.
If necessary, Coordinating Center staff, in collaboration with the PI and relevant
Working Committee Chairs, develop a supplemental form, which is approved prior
to soliciting centers for additional data. Use of supplemental data (e.g., data not
collected on standard CIBMTR data collection forms) is discouraged unless it will
result in a particularly meaningful publication and/or external funding can support
the extra burden placed on transplant centers and supplement forms
reimbursement costs.
Page | 132
CIBMTR 2015 Annual Report
APPENDIX F: STUDY DEVELOPMENT AND MANAGEMENT PROCESS
STUDY DEVELOPMENT AND MANAGEMENT PROCESS
Data file preparation. The objective of data file preparation is to create a file of
eligible subjects who are consecutively treated at participating centers with
adequate follow-up, with minimal missing data fields, and in large enough
numbers to give the analysis sufficient statistical power to meet the stated study
objectives. This process involves a series of steps by the MS-level statistician,
sometimes working with the Clinical Research Coordinator, to ensure data quality:
In Progress
(continued)
• Verifying selection criteria
• Including and excluding patients so that the investigators can determine
whether the final study population is representative of the target population
• Assessing follow-up
• Determining the extent and nature of missing values and their potential effect
on the study
• Resolving and reconciling data discrepancies / outliers by examining data
collection forms and communicating with centers and the PI
Analysis in progress. Analysis proceeds in several phases. The first generally
includes a detailed description of the patient population and univariate and
multivariate analyses of study endpoints. Coordinating Center personnel present
these data for discussion at a weekly Coordinating Center statistical meeting and
then distribute them to Writing Committee members for suggestions and
comments. The PI works with Coordinating Center staff in an iterative process to
review comments from the Writing Committee. The process repeats until final
analysis, which serves as the basis for the manuscript.
Ongoing. A study in ongoing status is long-term and often involves multiple grants
and/or renewals outside of the CIBMTR in order to reach its objectives. The study
has its own Statistical Director for analysis, but it requires data from the CIBMTR,
usually each year.
Preliminary
Results
Manuscript preparation. The PI is primarily responsible for manuscript
preparation and is expected to prepare a draft manuscript within 30 days of
receiving analysis results. The Working Committee leadership review and revise
the document, ensuring that the description and interpretation of the statistical
analyses are accurate and contribute to the fundamental message of the
manuscript. The Coordinating Center then distributes the approved first draft to
the Writing Committee and solicits feedback. The PI incorporates comments from
the Writing Committee and creates a revised draft, which is reviewed in an
iterative process by the Writing Committee until reaching a reasonable consensus
on a final manuscript.
Page | 133
CIBMTR 2015 Annual Report
APPENDIX F: STUDY DEVELOPMENT AND MANAGEMENT PROCESS
STUDY DEVELOPMENT AND MANAGEMENT PROCESS
Preliminary
Results
(continued)
Submitted. The Coordinating Center staff is responsible for submitting the
manuscript and corresponding with the chosen journal. The Working Committee
Scientific Director often serves as corresponding author, and the study statistician
forwards all editor and reviewer comments to the PI and Statistical Director. The
PI is expected to prepare a response, working with Coordinating Center staff who
provide additional analyses of data, as needed. Coordinating Center personnel
communicate with the journal, including re-submissions, in most cases.
In press. A publication is in press when it has been approved but does not yet
have a citation.
Completed
Published. A manuscript is considered published when a citation is available,
including a PMCID number, if applicable. For a list of 2015 publications, see
Appendix D.
Page | 134
CIBMTR 2015 Annual Report
APPENDIX G1: BMT CTN CLINICAL TRIALS
APPENDIX G: CLINICAL TRIALS
Through the Clinical Trials Support Program, the Coordinating Center supports clinical trial planning
and interpretation; data collection, including long-term follow-up data; and real-time accrual
assessment. See Section 2.3 for more information.
APPENDIX G1: BMT CTN CLINICAL TRIALS OPEN FOR ENROLLMENT
The BMT CTN (Section 2.3.1) is the US national trials group charged with developing and conducting
multicenter Phase II and III clinical trials focused on HCT. The CIBMTR is the lead institution for the
BMT CTN Data and Coordinating Center, which it runs in collaboration with NMDP/Be The Match and
the Emmes Corporation. A status of BMT CTN trials open for enrollment is included in this appendix
and is available on the BMT CTN website. For additional information on completed Network trials, see
the annual progress report on the BMT CTN website.
BMT CTN CLINICAL TRIALS OPEN FOR ENROLLMENT
Protocol
Number
BMT CTN
1101
BMT CTN
1102
BMT CTN
1202
BMT CTN
1203
Title
Status to Date
Phase III study comparing HLA• Opened to accrual Jun 2012
haploidentical related donor bone
marrow versus double umbilical cord
• 219 of 410 patients enrolled
blood with reduced-intensity conditioning • Anticipated accrual completion in
for patients with hematologic
2017
malignancies
A multi-center biologic assignment trial
comparing reduced intensity allogeneic
• Opened to accrual Dec 2013
hematopoietic cell transplant to
• 147 of 338 patients enrolled
hypomethylating therapy or best
• Anticipated accrual completion in
supportive care in patients aged 50-75
early 2018
with intermediate-2 and high risk
myelodysplastic syndrome
• Opened to accrual Jun 2013
• 1,708 of 1,500 patients enrolled;
Prospective multi-center cohort for the
accrual target increased to
evaluation of biomarkers predicting risk
enhance pediatric and minority
of complications and mortality following
patient accrual
allogeneic HCT
• Anticipated accrual completion in
Jun 2016
• Opened to accrual Sep 2014
A multi-center Phase II trial randomizing
novel approaches for graft-versus-host
• 209 of 270 patients enrolled
disease prevention compared to
• Anticipated accrual completion in
contemporary controls
April 2016
Page | 135
CIBMTR 2015 Annual Report
APPENDIX G1: BMT CTN CLINICAL TRIALS
BMT CTN CLINICAL TRIALS OPEN FOR ENROLLMENT
Protocol
Number
BMT CTN
1205
BMT CTN
1301
BMT CTN
1302
BMT CTN
1304
(DFCI 10-106)
BMT CTN
1505
(UT RECRUIT)
Title
Status to Date
• Opened to accrual Nov 2013
• 138 of 160 patients enrolled,
Easy-to-read informed consent (ETRIC) for
although accrual target may be
hematopoietic cell transplantation clinical
increased
trials
• Anticipated accrual completion in
2016
• Opened to accrual Aug 2015
Phase III trial of calcineurin inhibitor-free
• 9 of 345 patients enrolled
interventions for prevention of graft• Anticipated accrual completion in
versus host-disease
early 2019
Phase II, double-blind Placebo controlled • Opened to accrual Aug 2015
trial of maintenance ixazomib after
• 6 of 138 patients enrolled
allogeneic HCT for high risk multiple
• Anticipated accrual completion in
myeloma
June 2018
A randomized Phase III study comparing
• Opened to accrual by BMT CTN
conventional dose treatment using a
Nov 2013
combination of lenalidomide, bortezomib,
and dexamethasone (RVD) to high-dose
• 514 of 660 patients enrolled
treatment with peripheral stem cell
• Anticipated accrual completion in
transplant in the initial management of
2016
myeloma in patients up to 65 years of age
• Opened to accrual by BMT CTN
May 2015
• Patient enrollment: N/A, BMT CTN
Randomized minority patient recruitment
centers randomized to intervention
intervention trial
and control arms; center staff are
research subjects
• Anticipated accrual completion in
May 2017
Page | 136
CIBMTR 2015 Annual Report
APPENDIX G2: RCI BMT CLINICAL TRIALS
APPENDIX G2: RCI BMT CLINICAL TRIALS
The RCI BMT (Section 2.3.2) provides researchers in the field of HCT with infrastructure and expertise
in HCT clinical trial conduct and analysis. The program’s goal is to help investigators generate data
allowing novel and innovative ideas to move into the larger Phase II or Phase III setting into such
groups as the BMT CTN or the national cancer cooperative groups. A status of its projects is included
in this appendix.
RCI BMT CLINICAL TRIALS
Protocol #
Astellas
12-MOXE
Title
Unrelated donor sample collection for donors
whose recipient is enrolled in a randomized,
double-blind, placebo-controlled, Phase III trial
to evaluate the protective efficacy and safety
of a therapeutic vaccine, ASP0113, in
cytomegalovirus-seropositive recipients
undergoing allogeneic hematopoietic cell
transplant
Study of the anti-CD22 recombinant
immunotoxin moxetumomab pasudotox (CAT8015, HA 22) in children with B-lineage acute
lymphoblastic leukemia and minimal residual
disease prior to allogeneic hematopoietic cell
transplantation
09-SQOL
Pilot study to assess the feasibility of collecting
quality of life data in collaboration with the
Stem Cell Therapeutic Outcomes Database
11-TREO
Multi-center study evaluating treosulfan,
fludarabine, and low-dose TBI in children with
AML / MDS undergoing allogeneic HCT
COG-KIR
A multi-center study examining donor NK-cell
receptors and patient outcomes
Status To Date
• Donor sample collection only
• Opened to accrual Apr 2014
• Two donors enrolled
• RCI BMT closed study Dec 2014
• Opened to accrual May 2015
• One patient enrolled
• Study closed Sep 2015 due to
pharmaceutical company
decision
• Closed to accrual Sep 2013
• 301 adults and 89 pediatric
recipients enrolled
• Final subject follow-up expected
by end of 2014
• Data analysis in process
• Closed to accrual April 2014,
about one year earlier than
expected
• 40 of 40 targeted enrollment
• Follow-up continues
• Abstract submitted to 2016
EBMT Annual Meeting
• COG closed accrual May 2014
• URD sample management
• 609 of 1,200 samples collected
• 145 out of 400 targeted
enrollment
Page | 137
CIBMTR 2015 Annual Report
APPENDIX G2: RCI BMT CLINICAL TRIALS
RCI BMT CLINICAL TRIALS
Protocol #
DS05-02,
06-DON
Title
RDSafe: A multi-institutional study of
hematopoietic stem cell donor safety and
quality of life
PBMTC ONC A multi-center study to determine the role of
1001 / 09- minimal residual disease testing before and
MRD
after HCT for pediatric acute myeloid leukemia
09-PLEX
rHuG-CSF
PBSC
10-CBA
10 CMSMDS-1
A phase II study evaluating the safety and
efficacy of intravenous plerixafor for the
mobilization and transplantation of HLAmatched sibling donor hematopoietic stem
cells in recipients with hematological
malignancies
Long-term follow-up study evaluating
hematologic and non-hematologic cancers,
thrombotic events, and autoimmune disorders
in unrelated donors undergoing bone marrow
harvest versus peripheral blood stem cell
mobilization with recombinant human
granulocyte colony-stimulating factor
Filgrastim-mobilized peripheral blood stem
cells for allogeneic transplantation with
unrelated donors
A multi-center access and distribution protocol
for unlicensed cryopreserved cord blood units
for transplantation in pediatric and adult
patients with hematologic malignancies and
other indications
Assessment of allogeneic HCT in Medicare
beneficiaries with MDS and related disorders
Status To Date
• Closed to accrual July 2014
• 1,812 donors enrolled
• Follow up assessments
completed July 2015
• Abstract presented at 2015 BMT
Tandem Meetings
• Data review and analysis as well
as manuscript planning in
progress
• Closed to accrual Oct 2014
• 150 total enrollment
• Follow-up continues
• Closed to accrual Dec 2014
• Follow-up completed Feb 2016
• Oral abstract presented at 2015
ASH Annual Meeting
• Data review and analysis as well
as manuscript planning in
process
• Closed to accrual Oct 2015
• 21,569 total enrollment
• Follow-up continues through
2020
• Opened to accrual Apr 1996
• Just under 25,000 URDs enrolled
• Will close to accrual upon FDA
license; another protocol will
open for all unlicensed product
• Opened to accrual Oct 2010
• 2,757 enrolled
• Open indefinitely to allow
distribution and access to
unlicensed cord units
• Opened to accrual Dec 2010
• 1,294 patients enrolled
Page | 138
CIBMTR 2015 Annual Report
APPENDIX G2: RCI BMT CLINICAL TRIALS
RCI BMT CLINICAL TRIALS
Protocol #
KIR-DS
Statin
BMT CTN
1102-QOL
Title
A multi-center study looking at the selection of
a favorable KIR donor
Impact of donor statin use on graft-versus-host
disease after unrelated donor HCT; URD data
collection
A study comparing reduced intensity
allogeneic hematopoietic cell transplant to
hypomethylating therapy or best supportive
care in patients aged 50-75 with intermediate2 and high risk myelodysplastic syndrome
Status To Date
•
•
•
•
Opened to accrual Jun 2011
URD sample management
1,942 samples facilitated
Amendment in process to alter
donor sample logistics, which
will eliminated CIBMTR staff
involvement
• Opened to accrual Oct 2011
• 5,569 of 7,000 targeted donors
enrolled
• Survey Research Group
performing QOL assessments
• 210 total assessments
completed
13-TLEC
Prospective non-therapeutic study, assessing
the long-term toxicity of HCT for childhood
leukemia
• Opened to accrual Mar 2015
• 53 of 340 patients enrolled
13-SCP
A randomized study to evaluate the impact of
survivorship care planning on cancer survivors
self-management and adherence to care
recommendations and utilization of follow-up
care
• In collaboration with Health
Services Research Program
• Opened to accrual Apr 2015
• 181 of 495 patients enrolled
BMT CTN
1102Ancillary
CEA study
A cost effectiveness ancillary study to the
parent study 1102 above
HPD
High priority donor project supporting Be The
Match Operations
15-MMUD
Study of transplantation of HLA-mismatched
unrelated donor bone marrow for patients
with hematologic malignancies
• Collaborating with Fred
Hutchinson Cancer Research
center to perform Cost
Effectiveness Analysis (CEA)
study
• Survey Research Group to
perform CEA survey collection
• First subject contacted in Oct
2015
• First team meeting held in June
2015
• First subjects contacts by the
Survey Research Group in Sep
2015
• Protocol team established Oct
2015
• Protocol development in process
Page | 139
CIBMTR 2015 Annual Report
APPENDIX H: FORMS SUBMISSION PROCESS
APPENDIX H: FORMS SUBMISSION PROCESS
•
•
•
•
•
•
Center submits CRID Assignment Form (Form 2804), and CRID is generated
Indication for CRID Assignment Form (Form 2814) is added to Forms Due list
Center completes Indication Form and reports indication as HCT
Pre-TED (Form 2400) is added to Forms Due list
Center completes and submits Pre-TED
Pre-TED data are processed through the selection algorithm resulting in CRF or TED track
o If autologous recipient declines consent for research, stop here. Otherwise, follow the appropriate track
below
CRF Track
Forms 2004, 2005, and 2006 are added, depending on
1 donor type and if the donor has been used for a prior
transplant.*
2
Baseline form 2000, disease specific inserts, and Followup Forms are added to Forms Due list.
3 Center completes Baseline form after infusion.
TED Track
Forms 2004, 2005, and 2006 are added, depending
on donor type, consent for sample repository, and if
the donor has been used for a prior transplant.*
Post-TED Follow-up Form 2450 is added to Forms
Due list.
Center completes designated Post-TED Forms at
appropriate time points.
Center completes designated CRF Follow-up Forms at
appropriate time points.
Is recipient alive? If yes, go to Step 5. If no, report the
death on the follow-up form, and go to Reporting
Recipient Death.
Is recipient alive? If yes, go to Step 6. If no, report the
5 death on the follow-up form, and go to Reporting
Recipient Death.
Did recipient have a subsequent transplant? If yes, go
to Step 6. If no, continue reporting at next time point
(Step 3).
Did recipient have subsequent transplant? If yes, go to
6 Step 7. If no, continue reporting at next time point (Step
4).
Subsequent transplant is reported on the next
available follow-up form.
4
When the form reporting the subsequent transplant
When the form reporting the subsequent transplant is in
is in complete status, future forms for the prior
7 complete status, future forms for the prior transplant will
transplant will be automatically deleted from
be automatically deleted from FormsNet.
FormsNet.
Center completes and submits Pre-TED (Form 2400) for
8 subsequent transplant. Go to Step 2 for subsequent
transplant.
Center completes and submits Pre-TED (Form 2400)
for subsequent transplant. Go to Step 2 for
subsequent transplant.
Reporting Recipient Death
Death Form 2900 is completed to report the recipient’s
death.**
The recipient’s death is reported on the Post TED. A
2900 Death Form should not be completed for
patients on the TED track.
* For more details regarding when Forms 2004, 2005, and 2006 are required, see “How Forms Come Due (2004, 2005,
and 2006)”.
**
Complete Death Form 2900 even if autopsy is pending. Another death form will be requested to confirm cause of death
if autopsy was pending.
Page | 140
CIBMTR 2015 Annual Report
APPENDIX I: WEBSITES
APPENDIX I: WEBSITES
Throughout this report, electronic links to webpages and documents are provided. If you are unable to
access items using the links provided, enter the underlined words into a general search engine or the
search engine at the top of the CIBMTR website (cibmtr.org). URLs for the websites mentioned in this
report are provided here.
Name
Be The Match
Be The Match Clinical
BMT CTN
CIBMTR
CIBMTR Collaborate
CIBMTR Portal
HRSA Blood Cell Transplant
URL
bethematch.org
bethematchclinical.org
bmtctn.net
cibmtr.org
collaborate.cibmtr.org
portal.cibmtr.org
bloodcell.transplant.hrsa.gov
Page | 141
CIBMTR 2015 Annual Report
APPENDIX J: GLOSSARY
APPENDIX J: GLOSSARY
Abbreviation/
Meaning
Acronym
AGNIS
alloHCT
AML
ASBMT
ASH
autoHCT
BMT
BMT CTN
BRIDG
CALGB
CED
CIBMTR
CME
CMS
COG
CPI
CRF
CRID
DBtC
DFCI
DISCO
DRI
EBMT
eDBtC
FACT
FDA
HCT
HIPAA
HIV
HLA
HRSA
IND
IRB
IT
KIR
MCW
MDS
MED-A, MED-B
N/A
NCI
A Growable Network Information System
allogeneic hematopoietic cell transplantation
acute myeloid (myelogenous) leukemia
American Society of Blood and Marrow Transplantation
American Society of Hematology
autologous hematopoietic cell transplantation
bone marrow transplant
Blood and Marrow Transplant Clinical Trials Network
Biomedical Research Integrated Domain Group
Cancer and Leukemia Group B (member Alliance for Clinical Trials in Oncology)
Coverage with Evidence Determination
Center for International Blood and Marrow Transplant Research
continuing medical education
Centers for Medicare and Medicaid Services
Children’s Oncology Group
Continuous Process Improvement
Comprehensive Report Form
CIBMTR Recipient Identification Number
Data Back to Centers application
Dana Farber Cancer Institute
Data and Information for Statistical Center Operations
Disease Risk Index
European Group for Blood and Marrow Transplantation
enhanced Data Back to Centers application
Foundation for the Accreditation of Cellular Therapy
Food and Drug Administration
hematopoietic cell transplantation
Health Insurance Portability and Accountability Act
human immunodeficiency virus
human leukocyte antigen
Health Resources and Services Administration
Investigational new drug
Institutional Review Board
Information Technology
killer-cell immunoglobulin-like receptors
Medical College of Wisconsin
myelodysplastic syndrome
Minimum Essential Data forms
not applicable
National Cancer Institute
Page | 142
CIBMTR 2015 Annual Report
APPENDIX J: GLOSSARY
Abbreviation/
Meaning
Acronym
NK
NHLBI
NIAID
NIH
NMDP
PBMTC
PBSC
PI
PMCID
QOL
RCI BMT
RDSafe
RITN
SCTOD
TBD
TED
URD
US
vs
natural killer (cell)
National Heart, Lung, and Blood Institute
National Institute of Allergy and Infectious Disease
National Institutes of Health
National Marrow Donor Program
Pediatric Blood and Marrow Transplant Consortium
peripheral blood stem cell
principal investigator
PubMed Central unique identifier
quality of life
Resource for Clinical Investigations in Blood and Marrow Transplant
Related Donor Safety Study
Radiation Injury Treatment Network
Stem Cell Therapeutic Outcomes Database
to be determined
Transplant Essential Data
unrelated donor
United States
versus
Page | 143
The CIBMTR is supported by Public Health Service Grant/Cooperative Agreement 5U24CA076518 from the National Cancer Institute (NCI),
the National Heart, Lung and Blood Institute (NHLBI) and the National Institute of Allergy and Infectious Diseases (NIAID).
CIBMTR® (Center for International Blood and Marrow Transplant Research®) is a research collaboration between the National Marrow Donor Program®
(NMDP)/Be The Match® and Medical College of Wisconsin
Milwaukee Campus
Medical College of Wisconsin
9200 W. Wisconsin Ave., Suite C5500
Milwaukee, WI 53226 USA
(414) 805-0700
cibmtr.org
© 2016 The Medical College of Wisconsin, Inc. and the National Marrow Donor Program
Minneapolis Campus
National Marrow Donor Program/
Be The Match
500 N 5th Street
Minneapolis, MN 55401 USA
(612) 627-5800
cibmtr.org
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