This study is designed as a combined Phase II/III, randomized, open label, multicenter,
prospective comparative study of sirolimus plus prednisone versus
sirolimus/calcineurin-inhibitor plus prednisone for the treatment of chronic GVHD. Patients
will be stratified by transplant center and will be randomized to an experimental arm of one
of the two pre-specified experimental arms (sirolimus + prednisone or the comparator arm of
sirolimus + calcineurin inhibitor + prednisone) in a 1:1 ratio.
Phase:
Phase 2/Phase 3
Details
Lead Sponsor:
Medical College of Wisconsin
Collaborators:
Blood and Marrow Transplant Clinical Trials Network National Cancer Institute (NCI) National Heart, Lung, and Blood Institute (NHLBI) National Marrow Donor Program