Tacrolimus and Sirolimus as Prophylaxis After Allogenic Non-myeloablative Peripheral Blood Stem Cell Transplantation

Phase 2 Completed 31 enrolled Dana-Farber Cancer Institute Brigham and Women's Hospital · collab

NaSingle-groupOpen-labelTreatment

Summary

The purpose of this study is to extend the use of Tacrolimus and Sirolimus to determine how effective it is in preventing graft versus host disease (GVHD)in patients that have received non-myeloablative peripheral blood stem cell transplantation.

Timeline

Start: 2006-01
Primary completion: 2009-01
Completion: 2009-07

Publications

Results Ho VT, Aldridge J, Kim HT, Cutler C, Koreth J, Armand P, Antin JH, Soiffer RJ, Alyea EP. Comparison of Tacrolimus and Sirolimus (Tac/Sir) versus Tacrolimus, Sirolimus, and mini-methotrexate (Tac/Sir/MTX) as acute graft-versus-host disease prophylaxis after reduced-intensity conditioning allogeneic peripheral blood stem cell transplantation. Biol Blood Marrow Transplant. 2009 Jul;15(7):844-50. doi: 10.1016/j.bbmt.2009.03.017.

Drugs

Evaluation	Drug	Modality	Dose	Route
Subject	Sirolimus	Small molecule	—	Oral
Subject	Tacrolimus	Small molecule	—	Oral
Background	Busulfan	Small molecule	0.8 mg/kg	Intravenous
Background	Fludarabine	Small molecule	30 mg/m2	Intravenous

Tacrolimus and Sirolimus as Prophylaxis After Allogenic Non-myeloablative Peripheral Blood Stem Cell Transplantation

Summary

Timeline

Publications

Drugs

Indications