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A Multi-center Phase II Study of CC486-CHOP in Patients with Previously Untreated Peripheral T-cell Lymphoma
This is a phase II, multi-center study to determine the efficacy and safety of first-line CC-486 plus CHOP in patients with PTCL who have received no prior systemic therapy.
Primary Objective: To determine the complete response rate (CR) of CC486-CHOP in PTCL by 2014 International Working Group (IWG) criteria, and the Deauville Criteria for scan interpretation. CR rate after cycle 6 will be used for the purpose of interim efficacy analysis. Secondary Objectives: To determine overall response rate (ORR), safety, survival (progression-free survival and overall survival), and time to next treatment.
Adriamycin (doxorubicin); CC-486 (Azacitidine (Oral)); Vincristine (); cyclophosphamide (); cytoxan (cyclophosphamide); doxorubicin (); prednisone ()