Actively Recruiting
A Platform Protocol to Investigate Post-Transplant Cyclophosphamide-Based Graft-Versus-Host Disease Prevention in Patients With Hematologic Malignancies Receiving 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
N/A
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
Researchers are evaluating drug combinations to prevent graft-versus-host disease (GVHD) in people who have received stem cell transplants from unrelated donors with different blood types. This platform protocol focuses on safety and effectiveness of post-transplant cyclophosphamide (PTCy) based GVHD prevention after mismatched unrelated donor hematopoietic cell transplants in patients with malignant blood diseases. The study compares new drug combinations to a standard treatment. Participants receive one of the drug combinations after transplant, including investigational arms named ACCEL-001 and ACCEL-002, or the shared comparator control group. Conditioning regimens vary and may include combinations of drugs such as busulfan, fludarabine, melphalan, cyclophosphamide, and total body irradiation before transplant. The donor stem cell graft infusion occurs on Day 0, followed by specific post-transplant medications like cyclophosphamide, tacrolimus, mycophenolate mofetil, abatacept, and ruxolitinib, with supportive care for infection prevention and other complications. During the study, participants have regular doctor visits for check-ups and routine tests, complete surveys on physical and emotional health, and provide blood and stool samples. Researchers monitor outcomes including graft-versus-host disease-free, relapse-free survival one year after transplant, infection rates, survival, graft failure, and immune recovery. Safety is closely tracked, including monitoring for cytokine release syndrome and infections. The study lasts for at least one year post-transplant, with detailed data collection on treatment response and side effects.
CONDITIONS
Brief 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 (for MAC recipients)
- Ability to provide informed consent or have a legally authorized representative
- Willingness to comply with all study procedures and be available for the study duration
- Planned myeloablative conditioning (MAC) or reduced-intensity/nonmyeloablative conditioning (RIC/NMA) regimen as allowed
- Availability of a 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 (prior malignancy excluded from score)
- Diagnosed with eligible malignant hematologic diseases including specific leukemias, myelodysplastic syndromes, lymphomas, or myelofibrosis as defined
- Cardiac function with left ventricular ejection fraction ≥ 45% (MAC) or ≥ 40% (RIC/NMA)
- Estimated creatinine clearance ≥ 45 mL/min
- Pulmonary function with DLCO corrected for hemoglobin ≥ 50% and FEV1 predicted ≥ 50%
- Liver function acceptable per institutional guidelines
- Karnofsky Performance Status (KPS) score ≥ 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 give informed consent or comply with protocol and follow-up
- Previous allogeneic stem cell transplant
- Autologous transplant within the past 3 months
- Pregnant or breastfeeding
- Uncontrolled bacterial, viral, or fungal infection at transplant preparation
- Concurrent enrollment in another GVHD prevention clinical trial
- Undergoing desensitization to reduce anti-donor HLA antibodies before transplant
- HIV-positive with persistent viral load; well-controlled HIV with undetectable viral load and compliance with therapy is allowed
AI-Screening
AI-Powered Screening
Complete this quick 3-step screening to check your eligibility
Your Study Journey
Duration - 2 to 4 weeks
Participants are screened for eligibility to participate in the trial.
1 visit (in-person)
Duration - Approximately 7 to 10 days prior to transplantation
Participants receive a myeloablative or reduced-intensity conditioning regimen before transplantation, involving chemotherapy and/or radiation over several days.
Daily visits during conditioning period
Duration - 1 day
Participants receive an infusion of mismatched unrelated donor peripheral blood stem cells on Day 0.
1 visit (in-person) on transplantation day
Duration - 2 days
Participants receive cyclophosphamide on Days +3 and +4 after transplantation to prevent graft-versus-host disease.
2 visits (in-person) for cyclophosphamide infusions
Duration - From Day +5 up to approximately Day +180 post-transplant
Participants receive immunosuppressive medications including tacrolimus and mycophenolate mofetil starting from Day +5 to prevent graft-versus-host disease.
Regular visits for medication administration and monitoring over several months
Duration - From transplantation through at least 1 year post-transplant
Participants receive supportive treatments such as growth factors, infection prophylaxis, seizure prophylaxis, and are monitored closely for complications like cytokine release syndrome and infections.
Frequent visits including daily monitoring initially and periodic follow-ups thereafter
Duration - Up to 1 year post-transplant
Participants are monitored for graft-versus-host disease, relapse, survival, and other health outcomes for up to 1 year or longer after transplantation.
Periodic visits for assessments and monitoring
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
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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