Sirolimus/Tacrolimus Versus Tacrolimus/Methotrexate for Preventing Graft-Versus-Host Disease (GVHD) (BMT CTN 0402)

Phase 3 Completed 304 enrolled Medical College of Wisconsin Blood and Marrow Transplant Clinical Trials Network · collab National Cancer Institute (NCI) · collab National Heart, Lung, and Blood Institute (NHLBI) · collab

RandomizedParallel-groupOpen-labelTreatment

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.

Timeline

Start: 2006-11
Primary completion: 2012-10
Completion: 2015-10

Publications

Results Cutler C, Logan B, Nakamura R, Johnston L, Choi S, Porter D, Hogan WJ, Pasquini M, MacMillan ML, Hsu JW, Waller EK, Grupp S, McCarthy P, Wu J, Hu ZH, Carter SL, Horowitz MM, Antin JH. Tacrolimus/sirolimus vs tacrolimus/methotrexate as GVHD prophylaxis after matched, related donor allogeneic HCT. Blood. 2014 Aug 21;124(8):1372-7. doi: 10.1182/blood-2014-04-567164. Epub 2014 Jun 30.

Drugs

Evaluation	Drug	Modality	Dose	Route
Comparator	Methotrexate	Small molecule	10 mg/m2	—
Subject	Sirolimus	Small molecule	1 mg/m2	Oral
Subject	Sirolimus	Small molecule	4 mg	Oral
Subject	Tacrolimus	Small molecule	0.02 mg/kg	Intravenous

Sirolimus/Tacrolimus Versus Tacrolimus/Methotrexate for Preventing Graft-Versus-Host Disease (GVHD) (BMT CTN 0402)

Summary

Timeline

Publications

Drugs

Indications