Efficacy and Safety of Romidepsin CHOP vs CHOP in Patients With Untreated Peripheral T-Cell Lymphoma

This study is ongoing, but not recruiting participants.

Primary objective of the study is to compare the efficacy of romidepsin when administered with CHOP versus CHOP alone in subjects with previously untreated peripheral T-cell lymphoma (PTCL) in terms of progression-free survival (PFS) assessed according to Response criteria for malignant lymphoma 1999 by RAC.

Study Type:        Interventional

Study Design:        

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

Official Title:        PHASE 3 MULTI-CENTER RANDOMIZED STUDY TO COMPARE EFFICACY AND SAFETY OF ROMIDEPSIN CHOP (Ro-CHOP) VERSUS CHOP IN PATIENTS WITH PREVIOUSLY UNTREATED PERIPHERAL T-CELL LYMPHOMA                                                          

Condition:  Peripheral T-Cell Lymphoma                                      

Intervention:  

Drug: Romidepsin + CHOP    
Drug: CHOP                            

Phase:  Phase 3

External Link:  https://clinicaltrials.gov/show/NCT01796002