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 (BMT CTN Protocol #0801)

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.

本研究为一项针对慢性移植物抗宿主病（chronic Graft-versus-Host Disease, GVHD）的II/III期联合、随机、开放标签、多中心前瞻性对照临床试验，对比西罗莫司（sirolimus）联合泼尼松（prednisone）与西罗莫司/钙调磷酸酶抑制剂（calcineurin-inhibitor）联合泼尼松的治疗方案。
受试者将按移植中心进行分层，并以1:1比例随机分配至两个预先设定的研究组之一：西罗莫司联合泼尼松试验组，或西罗莫司联合钙调磷酸酶抑制剂联合泼尼松对照组。