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Clinical Trial 19204
Interventions:Cellcept (Mycophenolate Mofetil); Gleevac (Imatinib Mesylate); Imatinib Mesylate; Infliximab (Remicade); Jakafi (Ruxolitinib); Mycophenolate Mofetil; Pentostatin; Rapamune (Sirolimus); Rapamycin (Sirolimus); Rituxan (rituximab); Ruxolitinib; STI571 (Imatinib Mesylate); Sirolimus; everolimus (RAD001); methotrexate; rituximab
Study Type: Treatment
Phase of Study: Phase III
- Joseph Pidala
A Phase III Randomized Open-Label Multi-Center Study of Ruxolitinib vs. Best Available Therapy in Patients with Corticosteroid-Refractory Chronic Graft vs Host Disease after Allogeneic Stem Cell Transplantation (REACH 3)
The purpose of this study is to assess the efficacy of ruxolitinib against best available therapy in participants with steroid-refractory chronic graft-versus-host disease (SR cGvHD).
Primary Objective: To compare the efficacy of ruxolitinib versus Investigator's choice Best Available Therapy (BAT) in patients with moderate or severe SR-cGvHD assessed by Overall Response Rate (ORR) at the Cycle 7 Day 1 visit. Key Secondary Objectives: To compare the rate of failure free survival (FFS) and the change in the modified Lee cGvHD Symptom Scale score between treatment groups. FFS will be used as the first key secondary endpoint for all regions except in the US and the change in modified Lee cGvHD Symptom Scale score will be compared thereafter. In the US, the order will be reversed.