Supplementary Table 1 | Clinical trials (active, recruiting

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Supplementary Table 1 | Clinical trials (active, recruiting) investigating GVHD prevention strategies†
Identifier
Study Name
Investigational Agent
Eligibility
Primary Outcome Measure
Site
NCT01788501
Tacrolimus-MTX versus CSA-MTX for
prophylaxis of GVHD in pediatric patients
Tacrolimus-MTX vs
CSA-MTX
Disease: Hematologic malignancy
Donor: Not Specified
Age: < 18 years
Conditioning: Not Specified
Acute GVHD (day 100)
Korea
NCT00520130
Phase II trial of targeting immunedepleting chemotherapy and reduced
intensity allogeneic HSCT using 8/8 and
7/8 HLA-matched unrelated donors and
two GVHD prophylaxis regimens for the
treatment of leukemias, lymphomas, and
pre-malignant blood disorders
Multicenter trials to evaluate the efficacy
and toxicity of sirolimus/tacrolimus
combination as a GVHD prophylaxis after
HLA matched related PBSCT
Tacrolimus-MTXSirolimus vs
Campath-CSA
Disease: Hematologic malignancy
Donor: HLA match (related:
69-74 years) or 1-antigen mismatch
(unrelated: 18-74 years)
Age: 18-74 years
Conditioning: Reduced
Efficacy and safety of tacrolimus-MTXsirolimus vs alemtuzumab-CSA (for
example, engraftment, acute GVHD,
early and late treatment related
mortality and overall survival) (1 year)
USA
Tacrolimus-Sirolimus
Disease: Hematologic malignancy
Donor: HLA match (related)
Age: 20 – 60 years
Conditioning: Not Specified
Grade 2-4 acute GVHD (day 100)
Korea
NCT01203722
Reduced intensity, partially HLA
mismatched allogeneic BMT for
hematologic malignancies using donors
other than first-degree relatives
Tacrolimus-MMF vs
Sirolimus-MMF
Disease: Hematologic malignancy
Donor: HLA-mismatch (unrelated)
Age: 0.5 – 75 years
Conditioning: Myeloablative or reduced
Phase I: Severe acute GVHD (<25%)
and non-relapse mortality (<20%) (day
100)
Phase II: Survival without grade 3-4
GVHD or evidence of graft failure (day
180)
USA
NCT01303965
Phase I/II trial of allogeneic PBSCT
followed by maintenance therapy with
lenalidomide and sirolimus in patients with
high risk multiple myeloma
Tacrolimus-SirolimusLenolidomide
Disease: Multiple myeloma
Donor: HLA-match (related or
unrelated)
Age: ≥ 18 years
Conditioning: Reduced
Phase I: Safety
Phase II: 60% of patients alive and
progression-free (1 year)
USA
NCT01534143
A pilot study using high dose busulfan and
bortezomib as part of allogeneic
transplant conditioning regimen for high
Tacrolimus-SirolimusATG
Disease: Multiple myeloma
Donor: HLA-match (related or
unrelated)
Acute GVHD (6 months)
USA
NCT01488253
1
risk multiple myeloma patients
NCT01428973
Age: 18 – 70 years
Conditioning: Reduced
Allogeneic HCT from HLA-matched donors
after reduced intensity conditioning: a
phase II randomized study comparing two
GVHD prophylaxis regimens
Tacrolimus-Sirolimus
Disease: Hematologic malignancy
Donor: HLA-match (related or
unrelated)
Age: 16 – 75 years
Conditioning: Reduced
Progression-free survival
(1 year)
Belgium
NCT01251575
A phase II study to assess
immunosuppression with sirolimus
combined with cyclosporine and MMF for
prevention of acute GVHD after nonmyeloablative HLA class I or II
mismatched donor HCT – a multi-center
trial
CSA-MMF-Sirolimus
Disease: Hematologic malignancy
Donor: HLA-mismatch (related or
unrelated)
Age: Not Specified
Conditioning: Reduced
Grade 2-4 acute GVHD
(day 100)
USA
NCT01231412
A randomized phase 3 study to determine
the most promising postgafting
immunosuppression for prevention of
acute GVHD after unrelated donor
hematopoietic cell transplantation using
nonmyeloablative conditioning for patients
with hematologic malignancies: a multicenter trial
CSA-MMF-Sirolimus vs
CSA-MMF
Disease: Hematologic malignancy
Donor: HLA-match (unrelated)
Age: > 50 years
Conditioning: Reduced
Grade 2-4 acute GVHD
(day 100)
USA
NCT00074490
Allogeneic HSCT without preparative
chemotherapy or with low-intensity
preparative chemotherapy using sirolimus
and sirolimus-generated donor Th2 cells
for therapy of refractory leukemia,
lymphoma, myeloma or myelodysplastic
syndrome
CSA-Sirolimus
Disease: Hematologic malignancy
Donor: HLA-match (related)
Age: 16 to 75 years
Conditioning: Reduced
Safety and feasibility
GVHD rate
USA
NCT01582048
Multicenter phase II study of
peritransplantation immunosuppression
using ATG, rituximab, sirolimus and MMF
in patients receiving mismatched HCT
after reduced intensity conditioning with
Sirolimus-MMF-ATGRituximab
Disease: Hematologic malignancy
Donor: HLA-mismatch (unrelated)
Age: 18 – 75 years
Conditioning: Reduced
Treatment related mortality
(1 year)
Germany
vs
Tacrolimus-MMF
2
fludarabine and treosulfan
NCT00305682
Transplantation of unrelated donor
umbilical cord blood in patients with
hematological malignancies using a nonmyeloablative preparative regimen
Sirolimus-MMF
Disease: Hematologic malignancy
Donor: UCB
Age: up to 75 years
Conditioning: Reduced
Overall survival (1 year)
USA
NCT01713400
Tacrolimus, sirolimus and ustekinumab vs
tacrolimus and sirolimus for the
prevention of acute GVHD following
allogeneic HCT
Tacrolimus-SirolimusUstekinumab vs
Tacrolimus-Sirolimus
Disease: Hematologic malignancy
Donor: Not Specified
Age: 18 – 70 years
Conditioning: Myeloablative or reduced
Treg/total CD4+ ratio
(day 30)
USA
NCT00426517
Allogeneic and matched unrelated donor
stem cell transplantation for congenital
immunodeficiencies or patients with
autoinflammatory/ immunodysregulatory
conditions: busulfan-based conditioning
with Campath-1H or h-ATG, radiation, and
sirolimus
Nonmyeloablative haploidentical
peripheral blood mobilized hematopoietic
precursor cell transplantation for severe
congenital anemias
including sickle cell disease and betathalassemia
Campath or ATGSirolimus
Disease: Non-malignant
Donor: HLA-match (related or
unrelated) or UCB
Age: 2- 65 years
Conditioning: Reduced
Phenotypic correction of the disease
USA
AlemtuzumabSirolimus-Cy
Disease: Severe congenital anemias
Donor: HLA-haplotype
(related)
Age: ≥2 years
Conditioning: Reduced
Sustained donor type hemoglobin for
patients with sickle cell disease or are
transfusion-independent for patients
with thalassemia and not have severe
GVHD
(1 year)
USA
NCT00061568
Non-myeloablative allogeneic peripheral
blood mobilized hematopoietic precursor
cell transplantation for severe congenital
anemias including sickle cell disease,
thalassemia, and diamond blackfan
anemia
Campath-Sirolimus
Disease: Severe congenital anemias
Donor: HLA-match (related)
Age: 2 to 65 years
Conditioning: Reduced
Rate of engraftment (5 years)
USA
NCT01499888
Phase I/II study of allogeneic stem cell
transplantation to treat clinically
aggressive sickle cell disease
Campath-Sirolimus
Disease: Sickle cell disease
Donor: HLA-match (related)
Age: 18 – 60 years
Conditioning: Reduced
Engraftment (30 days)
USA
NCT01810926
A phase II multicentre, randomized,
controlled open-label study on the use of
MRD: CSA-MTXATG-F vs
Disease: Non-malignant
Donor: HLA match (related or
MRD: graft failure, grade 2-4 acute
GVHD, chronic GVHD, or death (first
Italy
NCT00977691
3
ATG-F and rituximab for
immunomodulation of GVHD in allogeneic
matched transplants for non-malignancies
CSA-MTX
MUD: CSA-MTXATG-F-Rituximab vs
CSA-MTX-ATG-F
CSA-MMF-ATG
unrelated)
Age: up to 64 years
Conditioning: Myeloablative
event)
MUD: grade 2-4 acute GVHD or EBV
viremia (first event)
Disease: Hematologic malignancy
Donor: HLA-match (related)
Age: up to 70 years
Conditioning: Reduced
Measure how frequently and to what
degree a complication of acute GVHD
occurs
USA
NCT00185640
Allogeneic HCT using a non-myeloablative
preparative regimen of total lymphoid
irradiation and ATG for older patients with
hematologic malignancies
NCT01856803
ATG for GVHD prophylaxis after HLAmatched sibling stem cell transplantation
in patients at 40 years of age or more
with hematological malignancies
CSA-MTX-MMF vs
CSA-MTX-MMF-ATG
Disease: Hematologic malignancy
Donor: HLA-match (related)
Age: 40 – 60 years
Conditioning: Myeloablative
Acute and chronic GVHD
(2 years)
China
NCT01883180
Viral infection in haploidentical
hematopoietic stem cell transplantation
with different dose of ATG for acute GVHD
prophylaxis
CSA-MTX-MMF-ATG
Disease: Require allogeneic HSCT
Donor: HLA-Haplotype (related)
Age: 14 – 65 years
Conditioning: Not Specified
Incidence of EBV and CMV infections
(2 years)
China
NCT01295710
Phase 3 study of US-ATG-F to prevent
moderate to severe chronic GVHD in adult
AML, ALL, or MDS patients after allogeneic
stem cell transplantation from unrelated
donors
CD34+ stem cell selection for patients
receiving partially matched family or
matched unrelated adult donor allogeneic
stem cell transplantations for malignant
and non-malignant disease
US-ATG-F vs placebo
Moderate to severe chronic GVHD or
death
USA
Safety, toxicity and feasibility of CD34+
stem cell selection in children,
adolescents and young adults
(10 years)
USA
CD34 selection for ex vivo T cell depletion
of mobilized peripheral blood stem cells
for recipients of HLA haploidentical related
donor stem cell grafts receiving intensive
conditioning
T-cell depletion
Disease: Require allogeneic HSCT for
AML, ALL, or MDS
Donor: HLA-match unrelated
Age: 18-65 years
Conditioning: Not specified
Disease: Hematologic malignancy and
non-malignant conditions
Donor: HLA-match (unrelated) or
mismatch (related)
Age: up to 26 years
Conditioning: Myeloablative or reduced
Disease: Hematologic malignancy
Donor: Lack of 5/6 or 6/6 HLA-match
Age: ≤ 55 years
Conditioning: Myeloablative
Engraftment & acute GVHD (day 100)
Severe chronic GVHD
(1 year)
USA
NCT01049854
NCT00368355
T-cell depletion
4
NCT01119066
A phase II trial of transplants from HLAcompatible related or unrelated donors
with CD34+ enriched, T cell depleted
PBSC isolated by the cliniMACS system in
the treatment of patients with hematolgic
malignancies and other lethal hematologic
disorders
A reduced intensity conditioning regimen
with CD3 depleted hematopoietic stem
cells to improve survival for patients with
hematologic malignancies undergoing
haploidentical stem cell transplantation
T-cell depletion
Disease: Hematologic malignancy
Donor: HLA-matched (related or
unrelated)
Age: up to 69 years
Conditioning: Myeloablative
Engraftment (3 years)
Acute and chronic GVHD
(3 years)
Non-relapse mortality, survival, and
disease-free survival (2 years)
USA
T-cell depletion
Disease: Hematologic malignancy
Donor: HLA-haplotype (related)
Age: up to 21 years
Conditioning: reduced
Event-free survival (1 year)
USA
Haploidentical stem cell transplantation
with fixed dose of T cells after in vitro
T cell depletion using CD3 monoclonal
antibody for children with acquired severe
aplastic anemia
Allogeneic HSCT for severe aplastic
anemia and other bone marrow failure
syndromes using G-CSF mobilized CD34+
selected hematopoietic precursor cells coinfused with a reduced dose of nonmobilized donor T cells
An investigator initiated double blind
randomized study of alefacept treatment
prevention of GVHD in myeloablative stem
cell transplantation
T-cell depletion
Disease: Severe aplastic anemia
Donor: HLA-haplotype (related)
Age: up to 21 years
Conditioning: Reduced
Engraftment and survival
(2 years)
Korea
T-cell depletion +
non-mobilized CD3+
T cells
Disease: Bone marrow failure
syndromes
Donor: HLA-match (related)
Age: 6 – 80 years
Conditioning: Reduced
Chronic GVHD (1 year)
USA
Alefacept
Disease: Require allogeneic HSCT
Donor: HLA-matched (related or
unrelated)
Age: 14 – 75 years
Conditioning: Myeloablative
Acute GVHD (day 100)
Israel
NCT01012492
Safety and tolerability trial of abataceptbased immunosuppression for prevention
of acute GVHD during unrelated donor
HSCT
CSA-MTX-Abatacept
Disease: Hematologic malignancy
Donor: HLA-match (unrelated)
Age: 12 years or older
Conditioning: Myeloablative
Safety and tolerability
(3 years)
USA
NCT00096161§
Pentostatin and donor lymphocyte infusion
for low donor T cell chimerism after HCT –
a multi-center trial
CSA-MMF-Pentostatin
Disease: Require allogeneic HSCT
Donor: HLA-match (related or
unrelated)
Age: Not Specified
Conditioning: Not Specified
Safety and efficacy (day 100)
USA
NCT00566696
NCT01759732
NCT01174108
NCT00361413
5
NCT01754389
A 3-arm randomized phase II study of
standard-of-care versus bortezomib based
GVHD regimen for reduced intensity
conditioning HSCT in patients lacking HLAmatched related donors
Tacrolimus-MTX vs
Tacrolimus-MTXBortezomib vs
Tacrolimus-SirolimusBortezomib
Disease: Hematologic malignancy
Donor: HLA matched (unrelated or
1-antigen mismatched related or
unrelated)
Age: 18 – 75 years
Conditioning: Reduced
Grade 2-4 acute GVHD
(180 days)
USA
NCT01926899
A phase I study evaluating the addition of
bortezomib to an established acute GVHD
prophylaxis regimen in pediatric allogeneic
HSCT
CSA-MTX-Bortezomib
Disease: Require allogeneic HSCT
Donor: HLA matched (related or
unrelated)
Age: 1 – 21 years
Conditioning: Not Specified
Maximum tolerated dose
(day 100)
USA
NCT01860170
A phase I trial of post-transplant
bortezomib and high dose Cy as GVHD
prophylaxis after reduced intensity
allogeneic HSCT
Bortezomib-Cy
Disease: Hematologic malignancy
Donor: HLA-match (related or
unrelated)
Age: ≥ 18 years
Conditioning: Reduced
Dose limiting toxicity (day 90)
USA
NCT01785810
A phase II study to assess the efficacy of
maraviroc a CCR5-antagonist in
prophylaxis of GVHD in patients with
hematologic malignancies undergoing
reduced intensity allogeneic stem cell
transplantation from unrelated donors
A pilot trial of vorinostat plus tacrolimus
and methotrexate to prevent GVHD
following unrelated donor HSCT
Tacrolimus-MTXMaraviroc
Disease: Hematologic malignancy
Donor: HLA-match (unrelated)
Age: ≥ 18 years
Conditioning: Reduced
Serious adverse events
(day 180)
Grade 2-4 acute GVHD
(day 180)
USA
Tacrolimus-MTXVorinostat
Feasibility (for example, administration
of at least 60% of planned doses for an
individual study patient) (day 30)
USA
NCT01451268
Phase I/II study with oral panobinostat
maintenance therapy following allogeneic
stem cell transplantation in patients with
high risk MDS or AML
Standard GVHD
prophylaxisPanobinostat
Disease: Hematologic malignancy
Donor: HLA matched (unrelated)
Age: 18 – 75 years
Conditioning: Myeloablative
Disease: AML, MDS, CMML
Donor: HLA-match (related or
unrelated)
Age: ≥ 18 years
Conditioning: Reduced
Maximum tolerated dose
(28 days after administration)
USA
NCT01790295
Exploring the potential of dual kinase JAK
1/2 inhibitor ruxolitinib (INC424) with
reduced intensity allogeneic HCT in
patients with myelofibrosis
Ruxolitinib
Disease: Primary myelofibrosis
Donor: HLA-match (related or
unrelated)
Age: 18-70 years
Conditioning: Reduced
Survival without graft failure (day 100)
USA
NCT01789255
6
NCT00425802
A nonmyeloablative conditioning regimen
with peri-transplant rituximab and the
transplantation of hematopoietic stem
cells from HLA-compatible related or
unrelated donors in patients with B cell
lymphoid malignancies
A pilot study of brentuximab vedotin in
the prevention of GVHD after mismatched
unrelated allogeneic stem cell
transplantation
CSA-MMF-Rituximab
Disease: B cell lymphoid malignancy
Donor: HLA-match (related)
Age: 18 – 70 years
Conditioning: Reduced
Overall and event-free survival (1 year)
USA
Tacrolimus-MTXBrentuximab
Disease: Hematologic malignancy
Donor: 6/8- or 8/8 mismatched
(unrelated)
Age: 18 – 65 years
Conditioning: Myeloablative
Maximum tolerated dose (37 days)
USA
NCT01749111
Randomized study to compare post bone
marrow transplant Cy with the
combination of MTX plus CNI for GVHD
prophylaxis (CICLODECH)
Cy vs CNI-MTX
Disease: Hematologic malignancy
Donor: HLA matched (related or
unrelated)
Age: 18-60 years
Conditioning: Not Specified
Patients alive, in remission, and without
immunosuppression
(1-year)
Brazil
NCT01349101
Post-transplant Cy for unrelated and
related allogeneic HSCT for hematological
malignancies
Tacrolimus-MMF-Cy
Disease: Hematologic malignancy
Donor: 0-, 1-, 2-, 3-, or 4-antigen
mismatch at HLA-A, -B, -C, -DR loci
(related) or up to two allele mismatch
(unrelated)
Age: ≥ 18 years
Conditioning: Myeloablative or reduced
Engraftment (day 100)
USA
NCT01315132
A two-step approach to matched sibling
allogeneic HSCT for high risk
hematological malignancies
Cy
Disease: Hematologic malignancy
Donor: HLA-match (related)
Age: ≥ 18 years
Conditioning: Myeloablative
Overall survival (1 year)
USA
NCT01749293
Partially HLA mismatched allogeneic BMT
for patients with hematologic malignancies
Tacrolimus-MMF-Cy
Disease: Hematologic malignancy
Donor: Lack full HLA-match
Age: 10 – 75 years
Conditioning: Reduced
Engraftment rates and incidence of full
donor chimerism (day 60)
USA
NCT01342289
Shortened-duration tacrolimus following
nonmyeloablative, related donor BMT with
high-dose posttransplantation Cy
Tacrolimus-MMF-Cy
Disease: Hematologic malignancy
Donor: HLA-haplotype (related)
Age: 0.5 – 75 years
Safety of reduced duration tacrolimus
(day 5 – day 120)
USA
NCT01700751
7
Conditioning: Reduced
NCT00358657
HLA-haploidentical related marrow grafts
for the treatment of primary
immunodeficiencies and other
nonmalignant disorders using conditioning
with low-dose cyclophosphamide, TBI,
and fludarabine; postgrafting
immunosuppression will consist of a single
low dose of cyclophosphamide, MMF, and
tacrolimus
Tacrolimus-MMF-Cy
Disease: Nonmalignant disease
Donor: HLA-haplotype (related)
Age: up to 54 years
Conditioning: Reduced
Safety (that is, probability of transplantrelated mortality exceeding 25% or of
grades 3-4 acute GVHD exceeding
25%) (day 100)
USA
NCT01747499
Phase I/II trial of intravenous azacitidine
in patients undergoing matched unrelated
stem cell transplantation
Tacrolimus-MTXAzacitidine
Disease: Hematologic malignancy
Donor: HLA-matched (unrelated)
Age: 18 – 65 years
Conditioning: Myeloablative or reduced
Phase 1: maximum tolerated dose (day
28)
Phase 2: Grade 2-4 acute GVHD (day
100)
USA
NCT01491958
Phase II trial evaluating the safety and
efficacy of atorvastatin for the prophylaxis
of acute GVHD in patients with
hematological malignancies
undergoing HLA-matched related donor
HSCT
Tac-MTX-Atorvastatin
Disease: Hematologic malignancy
Donor: HLA matched
(related)
Age: 18 – 75 years
Conditioning: Myeloablative or reduced
Grade 2-4 acute GVHD (day 100)
USA
NCT01665677
Phase II study of atorvastatin, micro-dose
methotrexate and tacrolimus administered
only to transplant recipients for the
prophylaxis of acute GVHD following
allogeneic HSCT
Tac-MTX-Atorvastatin
Disease: Hematologic malignancy
Donor: HLA matched (related or
unrelated)
Age: 18 – 75 years
Conditioning: Myeloablative or reduced
Grade 2-4 acute GVHD (1 year)
USA
NCT01527045
Donor statin treatment for prevention of
severe acute GVHD after
nonmyeloablative HCT
Donor: Atorvastatin
Disease: Hematologic malignancy
Donor: HLA matched (related)
Age up to 75 years
Conditioning: Reduced
Grade 3-4 acute GVHD (day 100)
USA
NCT00651716
Regulatory T cells at engraftment as
predictors of acute GVHD outcomes in
patients undergoing allogeneic stem cell
transplantation
T regulatory cells
Disease: Require allogeneic HSCT
Donor: Not Specified
Age: 18 years and older
Conditioning: Not Specified
Percentage of regulatory T cells at
engraftment
USA
NCT01660607
Phase I/II trial for patients with advanced
T-cell depletion
Disease: Hematologic malignancy
Event free survival post-HCT (1 year)
USA
8
hematologic malignancies undergoing
myeloablative allogeneic HCT with a T cell
depleted graft with simultaneous infusion
of conventional T cells and regulatory
T cells
T regulatory Cells
Donor: HLA-match (related)
Age: 13 to 60 years
Conditioning: Myeloablative
NCT00602693
Phase I study of infusion of UCB derived
CD25+CD4+ Treg cells after
nonmyeloablative cord blood
transplantation
T regulatory cells
Disease: Hematologic malignancy
Donor: 3 partial HLA-match (UCB units)
Age: 18 – 75 years
Conditioning: Reduced
Maximum tolerated dose
USA
NCT01818479
Phase I/II study of Treg/Tcon addback to
CD34 selected partially matched related
donor stem cells with myeloablative
conditioning for high risk hematologic
malignancies
Phase II trial using low dose IL-2 to
induce regulatory T cells in patients after
allogeneic HSCT as GVHD prophylaxis
T regulatory cells
Disease: Hematologic malignancy
Donor: 3-5/6 HLA-match (related)
Age: up to 70 years
Conditioning: Myeloablative
Grade 2-4 acute GVHD (day 100)
USA
IL-2
Disease: Hematologic malignancy
Donor: Not Specified
Age: up to 70 years
Condition: Not Specified
Dose limiting toxicity
(12 weeks)
USA
NCT01045382
Co-transplantation of mesenchymal stem
cells and HLA-mismatched allogeneic
hematopoietic cells after nonmyeloablative
conditioning: a phase II randomized
double-blind study
Mesenchymal Stem
Cells
Disease: Hematologic malignancy
Donor: HLA-mismatch (related or
unrelated)
Age: ≤ 75 years
Conditioning: Reduced
Overall survival (1 year)
Belgium
NCT01941394
Pilot study for safety and effectiveness
assessment of bone marrow mesenchymal
stem cell infusion for acute GVHD
prophylaxis and treatment after allogeneic
BMT
A phase I/II dose escalation study
evaluating safety and feasibility of
BPX-501 T cells after partially
mismatched, related, T cell-depleted HSCT
Mesenchymal Stem
Cells
Disease: Require allogeneic BMT
Donor: HLA-match (related or
unrelated)
Age: 18 – 60 years
Conditioning: Not Specified
Disease: ALL, AML, Lymphoma
Donor: Lack of 7/8 or 8/8 HLA-match
(related or unrelated)
Age: 18-65 years
Conditioning: Not Specified
GVHD (every 30 day for 1 year after
BMT)
Russia
Maximum dose resulting in adjusted
cumulative incidence of no more than
45% grade 2-4 acute GVHD and no
more than 17% grade 3-4 acute GVHD
(day 100)
USA
NCT00539695
NCT01744223
iCasp9 Suicide Gene
9
NCT01494103
Administration of haploidentical donor
T cells transduced with the inducible
caspase-9 suicide gene
iCasp 9 Suicide Gene
Disease: Hematologic malignancy
Donor: Lack of 5/6 or 6/6 HLA-match
Age: Not Specified
Conditioning: Not Specified
Effects of AP1903 administration
T cell dose that produces >25% risk of
≥ grade 2 GVHD (42 days).
Measure immune reconstitution of
recipients of iCasp9 T cells
USA
† As of November, 2013 www.ClinicalTrials.gov
Abbreviations: ATG, anti-thymocyte globulin; ATG-F, anti-thymocyte globulin-Fresenius; ALL, acute lymphoid leukemia; AML, acute myeloid leukemia; BMT, bone marrow
transplantation,; CMV, cytomegalovirus; CNI, calcineurin inhibitor; CSA, cyclosporine; EBV, epstein barr virus; GVHD, graft-versus-host disease; HCT, hematopoietic cell
transplantation; HSCT, hematopoietic stem cell transplantation; iCasp, inducible Caspase; MMF,mycophenolate mofetil; MDS, myelodysplastic syndrome; MRD, matched related donor;
MTX, methotrexate; MUD, matched unrelated donor; PBSCT, peripheral blood stem cell transplantation; UCB, umbilical cord blood
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