Multi-center Randomized Study to Compare Efficacy and Safety of Lenalidomide Plus CHOP (L-CHOP) Versus CHOP in Patients With Previously Untreated Peripheral T-cell Lymphoma

What this Trial Is About

Researchers are comparing the effectiveness and safety of a combination treatment called lenalidomide plus CHOP (L-CHOP) versus the standard CHOP regimen in patients with peripheral T-cell lymphoma (PTCL) who have not received prior treatment. This phase 2, multi-center, randomized study focuses on patients with confirmed PTCL to evaluate if adding lenalidomide to CHOP improves treatment outcomes. Participants are randomly assigned to one of two groups: one receiving the CHOP regimen alone, which includes cyclophosphamide, doxorubicin, vincristine, and prednisone every three weeks for six cycles; the other group receives the same CHOP regimen plus lenalidomide taken orally at 25 mg daily on days 1 through 10 of each 3-week cycle, for up to six cycles. The study has three phases: screening, treatment, and follow-up. Treatment continues unless patients experience unacceptable side effects, disease progression, or choose to withdraw. During the study, patients will be monitored closely with assessments after three and six treatment cycles to evaluate therapy effectiveness. Adverse events will be recorded each cycle. After treatment, patients are followed for up to three years or until disease progression or death to assess progression-free survival, overall survival, and safety. The primary outcome measured is the objective response rate at the end of six cycles, with ongoing safety and survival monitoring throughout the follow-up period.

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