NCT06550336

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

A Prospective, Single-center, Open-label Clinical Trial to Evaluate the Efficacy and Safety of Chidamide Monotherapy for Maintenance Therapy in CD30+ Peripheral T-cell Lymphoma (PTCL).

• Status: Active Not Recruiting
• Phase: Phase 2
• Study type: Interventional
• Enrollment: 35 (estimated)
• Sponsor: The First Hospital of Jilin University · Academic / Other
• Sex: All
• Age: 18 Years
• Healthy volunteers: Not accepted

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.

Conditions

• Peripheral T Cell Lymphoma

Interventions

Type	Name	Description
DRUG	Chidamide	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.

Timeline

• Start date: 2024-06-30
• Primary completion: 2027-12-30
• Completion: 2027-12-30
• First posted: 2024-08-13
• Last updated: 2024-08-29

Locations

1 site across 1 country: China