Title BMT CTN 0801) A Phase II/III Randomized, Multicenter Trial Comparing Sirolimus plus Prednisone and Sirolimus/Calcineurin Inhibitor plus Prednisone for the Treatment of Chronic Graft-versus-Host Disease
Principal Investigator George Chen, MD
Study Number 212512
Summary Patients will be stratified by transplant center and will be randomized to an experimental arm of sirolimus plus prednisone or the comparator arm of sirolimus plus calcineurin inhibitor plus prednisone. This Phase II study will proceed into the Phase III component of the protocol if the experimental arm is more efficacious than the comparator arm. Subjects that were enrolled on Phase II will continue to be followed for the Phase III endpoints.
Eligibility Please see ClinicalTrials.gov link