Actively Recruiting
A Platform Protocol to Investigate Post-Transplant Cyclophosphamide-Based Graft-Versus-Host Disease Prophylaxis in Patients With Hematologic Malignancies Undergoing Mismatched Unrelated Donor Peripheral Blood Stem Cell Transplantation
Led by Center for International Blood and Marrow Transplant Research · Updated on 2026-03-17
358
Participants Needed
13
Research Sites
148 weeks
Total Duration
On this page
Sponsors
C
Center for International Blood and Marrow Transplant Research
Lead Sponsor
N
National Marrow Donor Program
Collaborating Sponsor
AI-Summary
What this Trial Is About
The purpose of this clinical trial is to compare drug combinations to learn which drugs work best to prevent graft-versus-host-disease (GVHD) in people who have received a stem cell transplant. The source of stem cells is from someone who is not related and has a different blood cell type than the study participant. The researchers will compare the new drug combination to a standard drug combination. They will also learn about the safety of each drug combination. Participants will: * Receive the standard or new drug combination after transplant * Visit the doctor's office for check-ups and tests after transplant that are routine for most transplant patients * Take surveys about physical and emotional well-being * Give blood and stool samples.
CONDITIONS
Official Title
A Platform Protocol to Investigate Post-Transplant Cyclophosphamide-Based Graft-Versus-Host Disease Prophylaxis in Patients With Hematologic Malignancies Undergoing Mismatched Unrelated Donor Peripheral Blood Stem Cell Transplantation
Who Can Participate
Eligibility Criteria
You may qualify if you...
- Age 18 to under 66 years for chemotherapy-based conditioning or under 61 years for TBI-based conditioning (MAC recipients)
- Age 18 years or older (RIC/NMA recipients)
- Ability to provide informed consent
- Willingness to comply with all study procedures and availability for the study duration
- Planned myeloablative conditioning (MAC) or non-myeloablative/reduced-intensity conditioning (RIC/NMA) regimen per protocol
- Partially HLA-mismatched unrelated donor (4/8 to 7/8 match) aged 16-35
- Planned infusion of mismatched unrelated donor T-cell replete peripheral blood stem cell allograft
- Hematopoietic Cell Transplant Comorbidity Index (HCT-CI) less than 5
- Diagnosis of specific hematologic malignancies with disease criteria:
- AML, ALL, or other acute leukemia in first remission or beyond with ≤ 5% marrow blasts and no circulating or extramedullary blasts (MAC)
- MDS with < 10% blasts and no circulating blasts (MAC and RIC/NMA)
- Acute leukemia or CML with < 5% marrow blasts and no circulating or extramedullary blasts (RIC/NMA)
- CLL or other leukemias with chemosensitive disease (RIC/NMA)
- Higher-risk CMML or MDS/MPN without high-grade marrow fibrosis or massive splenomegaly (RIC/NMA)
- Lymphoma with chemosensitive disease (RIC/NMA)
- Primary or secondary myelofibrosis with grade 4 fibrosis (RIC/NMA)
- Cardiac function: left ventricular ejection fraction ≥ 45% (MAC) or ≥ 40% (RIC/NMA) with no heart failure
- Estimated creatinine clearance ≥ 45 mL/min
- Pulmonary function with DLCO corrected for hemoglobin ≥ 50% and FEV1 predicted ≥ 50%
- Liver function acceptable per local guidelines
- Karnofsky Performance Status (KPS) ≥ 70% (MAC) or ≥ 60% (RIC/NMA)
You will not qualify if you...
- Availability of a suitable HLA-matched related or fully matched unrelated donor
- Unable or unwilling to provide informed consent or comply with study protocol
- Prior allogeneic stem cell transplant
- Autologous transplant within the past 3 months
- Currently pregnant or breastfeeding
- Uncontrolled infections at time of transplant conditioning
- Concurrent participation in another GVHD prevention clinical trial
- Undergoing desensitization to reduce anti-donor HLA antibodies prior to transplant
- HIV-positive with persistently detectable viral load (well-controlled HIV with undetectable viral load on therapy allowed)
AI-Screening
AI-Powered Screening
Complete this quick 3-step screening to check your eligibility
Trial Site Locations
Total: 13 locations
1
University of Alabama Birmingham
Birmingham, Alabama, United States, 35294
Actively Recruiting
2
City of Hope
Duarte, California, United States, 91010
Actively Recruiting
3
Stanford
Palo Alto, California, United States, 94304
Actively Recruiting
4
University of Miami
Miami, Florida, United States, 33136
Actively Recruiting
5
University of Kansas Medical Center
Westwood, Kansas, United States, 66205
Actively Recruiting
6
Dana-Farber Cancer Institute
Boston, Massachusetts, United States, 02446
Actively Recruiting
7
Karmanos Cancer Institute
Detroit, Michigan, United States, 48201
Actively Recruiting
8
Memorial Sloan Kettering
New York, New York, United States, 10065
Actively Recruiting
9
University of North Carolina
Chapel Hill, North Carolina, United States, 27514
Actively Recruiting
10
Oregon Health & Science University
Portland, Oregon, United States, 97239
Actively Recruiting
11
MD Anderson
Houston, Texas, United States, 77030
Actively Recruiting
12
University of Virginia
Charlottesville, Virginia, United States, 22903
Actively Recruiting
13
Fred Hutchinson Cancer Center
Seattle, Washington, United States, 98109
Actively Recruiting
Research Team
L
Leigh Anne Blackmon, MSW
CONTACT
How is the study designed?
Study Type
INTERVENTIONAL
Masking
NONE
Allocation
RANDOMIZED
Model
PARALLEL
Primary Purpose
TREATMENT
Number of Arms
3
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