Investigating GVHD Prevention After Stem Cell Transplant
This study is testing different drug combinations to prevent graft-versus-host disease (GVHD) after a stem cell transplant for blood cancers like acute myeloid leukemia (AML) or myelodysplastic syndrome (MDS). You would receive a stem cell transplant from an unrelated donor whose blood cells don't perfectly match yours. Researchers are comparing standard drug combinations like busulfan and fludarabine, or fludarabine and TBI (total body irradiation), with new combinations of drugs such as fludarabine and melphalan, or fludarabine, cyclophosphamide, and TBI. The goal is to find out which combination works best to prevent GVHD and relapse, and to understand the safety of each approach. The study is open to adults aged 18 to 66.
- Study design
- This is an interventional study planning to enroll 358 participants. It is a platform protocol, meaning it will compare different treatment approaches to a control group.
- What's involved
- You would receive either a standard or new drug combination after your transplant. You will have routine doctor's visits and tests, complete surveys about your well-being, and provide blood and stool samples.
- Compensation
- Not stated in the trial record.
- Follow-up
- Researchers will measure your graft-versus-host disease-free, relapse-free survival (GRFS) at 1 year after your transplant.
AI-generated from the public study record. Only the study team can confirm whether you're eligible — confirm details with them before making decisions.
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
At a glance
Conditions
Where it's being run
13 sites across 12 statesWho to contact
Opens a ready-to-send draft in your own email app — review before sending.
What this trial measures
- Graft-versus-host disease-free, relapse-free survival (GRFS)1 year post-HCT
To compare GRFS following transplantation of a PBSC product from a MMUD between standard-of-care PTCy-based GVHD prophylaxis (the control arm) and the combination of reduced-dose PTCy, ruxolitinib, tacrolimus, and MMF.
- Graft-versus-host disease-free, relapse-free survival (GRFS)1 year post-HCT
To compare GRFS following transplantation of a PBSC product from a MMUD between standard-of-care PTCy-based GVHD prophylaxis (the control arm) and the combination of reduced-dose PTCy, abatacept, and tacrolimus.