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

Recruiting now · Phase 2

Conditions studied: AML (Acute Myelogenous Leukemia), Acute Lymphoid Leukemia (ALL), Acute Leukemia (Category), MDS (Myelodysplastic Syndrome), CML (Chronic Myelogenous Leukemia), CLL (Chronic Lymphocytic Leukemia), Prolymphocyctic Leukemia, Chronic Myelomonocytic Leukemia (CMML), Myeloproliferative Neoplasm (MPN), Lymphoma, Myelofibrosis

In brief

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.

Key facts

Study ID

NCT06859424

Run by

Center for International Blood and Marrow Transplant Research

People needed

358

Starts

2025-07-25

Expected to finish

2028-06-01

Last updated by the study team

2026-03-17

Who can join

Age: 18 and older, up to 66. Sex: any. Healthy volunteers: not accepted.

You may not qualify if…

• Suitable HLA-matched related or 8/8 high-resolution matched unrelated donor available
• Subject unwilling or unable to give informed consent, or unable to comply with the protocol including required follow-up and testing
• Subjects with a prior allogeneic transplant
• Subjects with an autologous transplant within the past 3 months
• Subjects who are breastfeeding or pregnant
• Uncontrolled bacterial, viral or fungal infection at the time of the transplant preparative regimen
• Concurrent enrollment on a GVHD prevention clinical trial
• Subjects who undergo desensitization to reduce anti-donor HLA antibody levels prior to transplant
• Patients who are HIV-positive with persistently positive viral load. HIV-infected patients on effective anti-retroviral therapy (ART) with undetectable viral load within 6 months are eligible for this trial. Patients with well-controlled HIV are eligible provided resistance panels are negative, the patient is compliant with ART, and their disease remains well controlled.

Where it is running

• University of Alabama Birmingham — Birmingham, Alabama, United States (enrolling)
• City of Hope — Duarte, California, United States (enrolling)
• Stanford — Palo Alto, California, United States (enrolling)
• University of Miami — Miami, Florida, United States (enrolling)
• University of Kansas Medical Center — Westwood, Kansas, United States (enrolling)
• Dana-Farber Cancer Institute — Boston, Massachusetts, United States (enrolling)
• Karmanos Cancer Institute — Detroit, Michigan, United States (enrolling)
• Memorial Sloan Kettering — New York, New York, United States (enrolling)
• University of North Carolina — Chapel Hill, North Carolina, United States (enrolling)
• Oregon Health & Science University — Portland, Oregon, United States (enrolling)
• MD Anderson — Houston, Texas, United States (enrolling)
• University of Virginia — Charlottesville, Virginia, United States (enrolling)
• Fred Hutchinson Cancer Center — Seattle, Washington, United States (enrolling)

Full record on ClinicalTrials.gov

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