A Retrospective Clinical Study on the First-line Maintenance Treatment of PTCL With Chidamide.

Recruiting

• Conditions: PTCL

• Registration Number: NCT05967949
• Lead Sponsor: The First Affiliated Hospital with Nanjing Medical University

Brief Summary

The efficacy and safety of chidamide in first-line maintenance therapy for PTCL will be assessed through a retrospective case analysis.

Detailed Description

The study design belongs to a retrospective study, collecting information on patients with PTCL who were diagnosed and treated with chidamide as maintenance therapy at our center. The collected data includes age, gender, previous treatment regimens, results of auxiliary examinations (such as blood routine, biochemistry, bone marrow cytology, pathology, flow cytometry, NGS, etc.), as well as PET-CT images. The safety and efficacy of Chidemide as first-line maintenance therapy in PTCL will be analyzed.

Study Timeline

• Study Start: 2023-04-01
• Status Verified: 2023-07
• Study First Submitted: 2023-07-23
• Study First Submitted QC: 2023-07-23
• Last Update Submitted: 2023-07-23
• Study First Posted: 2023-08-01
• Last Update Posted: 2023-08-01
• Primary Completion: 2026-04-01
• Study Completion: 2028-04-01

Recruitment & Eligibility

• Status: RECRUITING
• Sex: All
• Target Recruitment: 200

Inclusion Criteria

• (1) Age: 18 years and older; (2) Gender: Male/Female; (3) Diagnosed with PTCL; (4) Received chidamide as maintenance therapy after first-line treatment.

Exclusion Criteria

• (1) Patients with other types of lymphomas; (2) Pregnant women.

Study & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
PFS	2 years	progression free survival

Secondary Outcome Measures

Name	Time	Method
OS	2 years	overall survival
CR	2 years	complete remission
DOR	2 years	duration of remission

Trial Locations

Locations (1)

Hematological Department, People's Hospital of Jiangsu Province; 🇨🇳 Nanjing, Jiangsu, China