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

Peripheral T-Cell Lymphoma Clinical Trial

Official title:
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

Clinical Trial Summary

This study aims to compare the efficacy and safety of lenalidomide plus CHOP (L-CHOP) versus CHOP alone in patients with previously untreated peripheral T-cell lymphoma (PTCL)

Clinical Trial Description

This is a randomized, multi-center, open-label study to compare efficacy and safety of L-CHOP with standard CHOP regimen in patients with previously untreated PTCL. Study subjects are patients with histologically proven PTCL. Patients are randomized 1:1 to receive either cyclophosphamide, doxorubicin, vincristine and prednisone (CHOP) administered in 3 week cycles for 6 cycles or Lenalidomide plus CHOP (L-CHOP) administered in 3 week cycles for 6 cycles. In the L-CHOP arm, Lenalidomide will be administered at a dose of 25mg po on day 1-10 every 3 weeks. This study is divided into three phases: screening phase, treatment phase and follow-up phase. Patients will receive study drug(s) for up to 6 cycles, or until unacceptable toxicity will develop or progression or voluntary with drawl. Adverse event of every treatment cycle will be recorded. Therapy efficacy will be evaluated after finishing 3 cycles and finishing 6 cycles therapy. Patients will be followed until disease progression, died or 3 years from the last patient randomized. ;

Study Design

Related Conditions & MeSH terms

Clinical Trial Details
NCT number NCT04922567
Study type Interventional
Source Second Affiliated Hospital, School of Medicine, Zhejiang University
Contact Wenbin Qian, Prof.
Phone +86-13605801032
Email qianwb@zju.edu.cn
Status Recruiting
Phase Phase 2
Start date April 1, 2021
Completion date December 31, 2026
View Details
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