CC486-CHOP in Patients with Previously Untreated Peripheral T-cell Lymphoma

Recruiting

This is a phase II, multi-center study to determine the efficacy and safety of first-line CC-486 plus CHOP in patients with Peripheral T-cell Lymphoma (PTCL) who have received no prior systemic therapy. The main objective is to determine the complete response rate (CR) of CC486-CHOP in PTCL. CR rate after cycle 6 will be used for the purpose of interim efficacy analysis.

Study Type:        Interventional

Study Design:        

Allocation: Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Single Group Assignment
Masking: Open Label
Primary Purpose: Treatment

Official Title:    A Multi-center Phase II Study of CC486-CHOP in Patients With Previously Untreated Peripheral T-cell Lymphoma                                                           

Condition:  Peripheral T-Cell Lymphoma                                      

Intervention:  

Drug: CC-486     
Drug: CHOP                            

Phase:  Phase 2

External Link:  https://clinicaltrials.gov/ct2/show/NCT03542266