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Clinical Trial 18626
Cancer Type: Malignant Hematology
Study Type: Treatment
Phase of Study: Phase II
- Joseph Pidala
Carfilzomib for Treatment of Chronic Graft vs. Host Disease
The purpose of this research study is to see if Carfilzomib is helpful in the treatment of chronic graft-versus-host disease (GVHD). The study will enroll people who have active chronic GVHD despite at least one prior chronic GVHD treatment. The study will also examine how chronic GVHD affects quality of life and symptoms, and will explore the impact of this treatment on the immune system.
Primary Objective: Determine the proportion of subjects with treatment failure by 6 months after carfilzomib treatment for chronic GVHD. Secondary Objectives: 1. Determine 3 month overall (complete + partial), and complete response rate. 2. Determine 6 month overall (complete + partial), and complete response rate. 3. Report overall survival, non-relapse mortality, primary malignancy relapse, failure-free survival, treatment success, and discontinuation of immune-suppressive therapy at 6 months and 1 year. 4. Examine functional outcome (2-minute walk test) and patient-reported outcomes (Lee Chronic GVHD Symptom Scale, quality of life (SF-36, FACT-BMT), Human Activity Profile (HAP)) at study enrollment, 6 months and 1 year. 5. Study biologic effects of proteasome inhibition.