Graft vs Host Disease Clinical Trial
Official title:
A Randomized Double Blinded Placebo-Controlled Phase III Trial Comparing Cyclosporine Plus Steroids With or Without Myfortic as Primary Treatment for Extensive Chronic Graft Versus Host Disease
The purpose of this study is to determine whether the response to treatment for extensive chronic Graft versus Host Disease (cGvHD)is improved with the addition of myfortic alongside cyclosporine A and prednisone, compared to the reference treatment of cyclosporine A and prednisone alone.
This clinical trial is a European, multi-center, randomized, double blinded
placebo-controlled trial comparing CsA+PDN+MPA versus the reference treatment of CsA+PDN
alone + placebo, in patients with extensive chronic GvHD. Randomization will be stratified
according to:
- Platelet number (low versus high risk)
- Source of transplantable cells (marrow versus PBSC versus cord blood)
Patients not in progression at 6 weeks post randomization (progression defined as primary
failure) will be evaluated for remission (complete or partial) at 3, 6, 9, & 12 months post
randomization
;
Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Parallel Assignment, Masking: Double-Blind, Primary Purpose: Treatment
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