Overview

TAC/MTX vs. TAC/MMF/PTCY for Prevention of Graft-versus-Host Disease and Microbiome and Immune Reconstitution Study (BMT CTN 1703/1801)

Status:
Active, not recruiting

Trial end date:
2024-02-01

Target enrollment:

Participant gender:

Summary

1703: The study is designed as a randomized, phase III, multicenter trial comparing two acute graft-versus-host disease (aGVHD) prophylaxis regimens: tacrolimus/methotrexate (Tac/MTX) versus post-transplant cyclophosphamide/tacrolimus/mycophenolate mofetil (PTCy/Tac/MMF) in the setting of reduced intensity conditioning (RIC) allogeneic peripheral blood stem cell (PBSC) transplantation. 1801: The goal of this protocol is to test the primary hypothesis that the engraftment stool microbiome diversity predicts one-year non-relapse mortality in patients undergoing reduced intensity allogeneic HCT.

Phase:

Phase 3

Details

Lead Sponsor:

Medical College of Wisconsin

Collaborators:

Blood and Marrow Transplant Clinical Trials Network
National Cancer Institute (NCI)
National Heart, Lung, and Blood Institute (NHLBI)
National Marrow Donor Program

Treatments:

Cyclophosphamide
Methotrexate
Mycophenolic Acid
Tacrolimus