drugset / Trial / NCT00144677

Sirolimus With Tacrolimus for Graft-vs-Host Disease Prophylaxis After Un-Related Stem Cell Transplantation

NCT00144677 ↗

Phase 2 Completed 30 enrolled Dana-Farber Cancer Institute
Non-randomizedSingle-groupOpen-labelPrevention

Summary

The purpose of this study is to evaluate the ability of sirolimus to prevent graft versus host disease (GVHD) in patients following stem cell transplant from an unrelated donor. This trial is designed to test the hypothesis that elimination of methotrexate in the unrelated donor group would lead to less transplant-related toxicity while still preserving the effective control of GVHD.

Timeline

Start
2003-11
Primary completion
2006-06
Completion
2006-06

Drugs

EvaluationDrugModalityDoseRoute
Subject Sirolimus Small molecule — Oral
Background Tacrolimus Small molecule — Intravenous