A Clinical Study Assessing the Efficacy of Chidamide for CD30-positive Peripheral T-cell Lymphoma (PTCL).

Summary

* Objective:This study aims to assess the efficacy and safety of Chidamide as a monotherapy maintenance treatment for patients with newly diagnosed peripheral T-cell lymphoma (PTCL) who have achieved remission or stable disease after initial brentuximab vedotin (BV) plus cyclophosphamide, doxorubicin and prednisone (CHP)treatment, excluding ALK+ anaplastic large-cell lymphoma (ALCL). * Design: The study is a prospective, single-center, open-label clinical trial. * Treatment:Eligible patients will receive Chidamide tablets at a dosage of 20 mg (4 tablets) twice weekly. Treatment cycles are 4 weeks long and will continue until disease progression, unacceptable toxicity, patient withdrawal, investigator decision to discontinue, loss to follow-up, death, or study termination. * Endpoints:The primary endpoint is the 2-year progression-free survival (PFS). Secondary endpoints include the overall response rate (ORR), overall survival (OS), and safety indicators. * Rationale:The study seeks to provide a basis for the dosing regimen of Chidamide and contribute to the development of effective maintenance treatment strategies for PTCL patients.

Timeline

Start

2024-06-30

Primary completion

2027-12-30

Completion

2027-12-30

Drugs

Indications