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
Start Date
7/25/2025
Completion Date
6/1/2028
Summary
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.
Detailed Description
This platform protocol will evaluate the safety and efficacy of post-transplant cyclophosphamide (PTCy) based graft-versus-host disease (GVHD) prophylaxis after mismatched unrelated donor (MMUD) hematopoietic cell transplant (HCT). Participants with malignant hematologic diseases eligible per inclusion criteria, receiving MMUD peripheral blood stem cells (PBSCs) after myeloablative conditioning (MAC) or reduced-intensity conditioning (RIC) will be eligible to be enrolled by participating transplant centers. The platform protocol will estimate endpoints and provide a comparator arm for investigational interventional arms (ISAs). Two investigational ISAs are part of the platform protocol - ACCEL-001 and ACCEL-002. The ISAs describe the specific features of the intervention being studied and treatment of participants assigned to that intervention, the specific target population, sample size required based on comparison to the control arm, specific study objectives, statistical methods for evaluating the interventions, and other specific intervention-related information and assessments. Additional ISAs may be added or closed throughout the lifetime of the trial.
Eligibility Criteria
Age Range: 18 years to 66 years
Interventions
Conditioning Regimen A
Conditioning Regimen B
Conditioning Regimen C
Conditioning Regimen D
Conditioning Regimen E
Hematopoietic Cell Transplantation
PTCy (50 mg/kg D3, D4)
PTCy (25 mg/kg D3, D4)
Post-transplant Tacrolimus
Post-transplant Mycophenolate mofetil
Post-transplant Abatacept
Post-transplant Ruxolitinib
Supportive Care: Growth Factors
Supportive Care: Blood Products
Supportive Care: Infection Prophylaxis
Supportive Care: Intravenous immune globulin (IVIG)
Supportive Care: Seizure prophylaxis
Supportive Care: Monitoring and management of CRS
Supportive Care: Prophylaxis against infections
Supportive Care: Prophylaxis against infections
Supportive Care: Lipid elevations
Study treatment compliance
Prohibited Concomitant Therapy
Permitted Concomitant Therapy
Prohibited Concomitant Therapy
Permitted Concomitant Therapy
Prohibited Concomitant Therapy
Permitted Concomitant Therapy
Conditions
Locations
University of Alabama Birmingham
Birmingham, Alabama 35294
United States
City of Hope
Duarte, California 91010
United States
Stanford
Palo Alto, California 94304
United States
University of Miami
Miami, Florida 33136
United States
University of Kansas Medical Center
Westwood, Kansas 66205
United States
Dana-Farber Cancer Institute
Boston, Massachusetts 02446
United States
Karmanos Cancer Institute
Detroit, Michigan 48201
United States
Memorial Sloan Kettering
New York, New York 10065
United States
University of North Carolina
Chapel Hill, North Carolina 27514
United States
Oregon Health & Science University
Portland, Oregon 97239
United States
MD Anderson
Houston, Texas 77030
United States
University of Virginia
Charlottesville, Virginia 22903
United States
Fred Hutchinson Cancer Center
Seattle, Washington 98109
United States