* 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.
Study Type
INTERVENTIONAL
Allocation
NA
Purpose
TREATMENT
Masking
NONE
Enrollment
35
20 mg (4 tablets) twice a week, specifically on days 1, 4, 8, 11, 15, 18, 22, and 25.Each 4-week period constitutes one treatment cycle.
The First Bethune Hospital of Jilin University
Changchun, Jilin, China
2-year progression-free survival (PFS) rate
PFS was defined as the time between diagnosis and the first date of relapse or all-cause death, whichever occurred first.
Time frame: 24months
overall survival (OS)
OS was defined as the time after the date of diagnosis until all-cause death.
Time frame: 48months
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