drugset / Trial / NCT01188798

Methotrexate or Pentostatin for Graft-versus-host Disease Prophylaxis in Risk-adapted Allogeneic Bone Marrow Transplantation for Hematologic Malignancies

NCT01188798

Phase 3 Completed 6 enrolled St. Jude Children's Research Hospital
RandomizedParallel-groupOpen-labelTreatment

Summary

The purpose of the study is to determine if participants who receive the GVHD prophylaxis medication pentostatin will have less severe hepatic toxicities than those receiving MTX. The study is estimated to have sufficient statistical power to ascertain at least a 20% improvement in day 42 NCI CTC grade 2 or above hepatic toxicity-free survival in pentostatin recipients.

Timeline

Start
2010-09
Primary completion
2012-02
Completion
2012-02

Drugs

EvaluationDrugModalityDoseRoute
Subject Methotrexate Small molecule
Subject Pentostatin Small molecule