Sirolimus/Tacrolimus Versus Tacrolimus/Methotrexate for Preventing Graft-Versus-Host Disease (GVHD) (BMT CTN 0402)
Status:
Completed
Trial end date:
2015-10-01
Target enrollment:
Participant gender:
Summary
The study is designed as a phase III, randomized, open label, multicenter, prospective,
comparative trial of sirolimus and tacrolimus versus tacrolimus and methotrexate as
graft-versus-host disease (GVHD) prophylaxis after human leukocyte antigen (HLA)-matched,
related, peripheral blood stem cell transplantation in individuals with hematologic cancer.
Participants will be stratified by transplant center and will be randomly assigned to the
sirolimus/tacrolimus or tacrolimus/methotrexate arms at a 1:1 ratio.
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)