What is this study investigating for preventing graft-versus-host disease after stem cell transplant?

This trial is studying different drug combinations to find which works best to prevent graft-versus-host disease in patients receiving mismatched unrelated donor stem cell transplants for blood cancers. Researchers aim to compare new treatments to standard care and learn about their safety. The Center for International Blood and Marrow Transplant Research leads this study.

Who may be eligible for this graft-versus-host disease clinical trial?

Adults aged 18 to 66 with malignant blood diseases who are receiving a mismatched unrelated donor stem cell transplant may be eligible. Both men and women can participate if they meet health and transplant criteria. Patients must be willing and able to follow study procedures. Please review eligibility criteria for more details.

Is there any cost to participate in this graft-versus-host disease clinical trial?

Study-related care, including the study drugs and all trial visits, is provided at no cost. However, personal travel and other expenses may vary and are not guaranteed to be covered. Participants should plan accordingly.

Actively Recruiting

Phase 2

Age: 18Years - 66Years

All Genders

ID06859424

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

Research Sites

N/A

Total Duration

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

Age: 18Years - 66Years

All Genders

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

Research Team

Leigh Anne Blackmon, MSW

Not the Right Trial for You?

Explore thousands of other clinical trials that might be a better match.
Sign up to get personalized trial recommendations delivered to your inbox.

Already have an account? Log in here