Description Module
The Description Module contains narrative descriptions of the clinical trial, including a brief summary and detailed description. These descriptions provide important information about the study's purpose, methodology, and key details in language accessible to both researchers and the general public.
Description Module path is as follows:
Study -> Protocol Section -> Description Module
Description Module
Ignite Creation Date:
2025-12-25 @ 12:37 AM
Ignite Modification Date:
2025-12-25 @ 12:37 AM
NCT ID:
NCT04922567
Brief 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)
Detailed 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:
NCT04922567
Study Brief:
Protocol Section:
NCT04922567