RFA#C14-0042

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RFA#C14-0042
Ancillary research using clinical data and biospecimens from the Blood and
Marrow Transplant Clinical Trials Network (BMT CTN)
Released:
September 23, 2014
Request for Applications
Ancillary research using clinical data and biospecimens from the Blood and
Marrow Transplant Clinical Trials Network (BMT CTN)
Many questions remain unanswered about hematopoietic cell transplantation. Studies that
have prospectively collected clinical data and accompanying biospecimens can be particularly
meaningful. The Blood and Marrow Transplant Clinical Trials Network (BMT CTN) is calling for
proposals from investigators who wish to address supplemental questions that develop from
our portfolio of prospective clinical trials and available research specimens.
Proposed studies may include, but should not be limited to:
 secondary endpoint analyses from the clinical trials
 analyses of subsets for specific endpoints addressed in the clinical trials
 genetic modifiers of response to transplant including HLA and non-HLA genetic studies
of patients and donors
 biomarkers predictive of complications or response
 genetic or biological markers associated with the underlying disease for which the
patient received transplantation, addressing questions beyond the efficacy and outcome
of the transplant itself.
The rich resource of clinical data and literally thousands of biospecimens from seven completed
prospective BMT CTN trials are currently available for the proposed work. A listing of these
trials and available biospecimen sample types are listed below. Detailed information regarding
the clinical protocols, research sample collection schedules, available sample types, processing
& storage information and available biospecimen inventories for each of these specimen
collections can be found on the public BMT CTN website
(https://web.emmes.com/study/bmt2/Researchsample.html).
BMT CTN 0102: Patient - Serum, PBMC; Donor - Stem cell product aliquots
BMT CTN 0201: Patient - Serum and Plasma
BMT CTN 0302: Patient - Whole blood, Buccal cells, and Serum
BMT CTN 0401: Patient - PBMC
BMT CTN 0402: Patient – Serum and Plasma; Donor – Baseline Serum, Plasma and WBC Pellets
BMT CTN 0701: Patient - PBMC
BMT CTN 0802: Patient - Whole blood, Buccal cells, and Plasma
Application Instructions
IMPORTANT DATES AND DEADLINES
Application & Project Milestone Schedule
Release of RFA#C14-0042
September 23, 2014
Written Questions can be submitted via E-Mail through:
November 7, 2014
(Questions will be promptly reviewed by the BMT CTN DCC and a response returned directly to
the investigator submitting the question.)
Proposals Due at 4:00 p.m. Central Time
November 15, 2014
Project Selections and Award Announcements
Project Start Date
Completion of Selected Ancillary Studies
Presentation of Results to BMT CTN Steering Cmte
By December 17, 2014
January 1, 2015
By December 31, 2015
February 10, 2015 (Tandem
Meetings, San Diego)
Responses must be submitted via Email to:
Renée Carby – Contracts Representative
National Marrow Donor Program
3001Broadway Street N.E. Broadway Ridge, Suite 100
Minneapolis, MN 55413-1753
Telephone: 612.884-8738
Email: rcarby@nmdp.org
Application Guidelines
Applications can include requests for samples and clinical data collected through the listed
prospective trials, funding to support EMMES/CIBMTR biostatistical assistance as needed for
analysis at the rate of $105/hr. and/or funding to support testing the biospecimens.
Applications will be received for projects that can be completed within one year from the time
of award.

Applications (4 page proposal; 2 page study budget maximum) should be submitted
using the attached proposal and budget submission form. Proposals should provide a
detailed rationale, background, question(s) to be addressed, pertinent methods plus
detailed specification of the requested clinical data and biospecimens.

The RFA has set a not-to-exceed 28% indirect/administrative rate as funds will come out of the
BMT CTN patient reimbursement budget used for protocols. (Protocol budgets incorporate the
28% indirect rate).


Additionally, purchasing of equipment will not be covered by this award.
It is expected that results obtained from the completed study will result in an abstract to
be presented at a scientific meeting and/or will form the basis of pilot data for a future
grant application.
Review Process
 Applications will be reviewed by an Ad Hoc Committee appointed by the BMT CTN
Executive Committee. Applications will be awarded on the basis of scientific merit, impact
of the proposed study, feasibility of completion within a one year timeline and the scope of
the requested budget. Final project funding decisions will be made by the Executive
Committee based upon study rankings and available funding.
 Awardees will be notified in mid-December and provided an agreement. Funds will be
available for disbursement by December 31, 2014, pending required contractual
documentation.
For questions concerning the biospecimen inventory please contact Alan Howard at
ahoward@nmdp.org . For questions concerning the RFA, or the application and submission
process please contact Renee Carby, Contract Manager at rcarby@nmdp.org,
Questions will be promptly reviewed by the BMT CTN DCC and a response returned directly to
the investigator submitting the question.
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