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

PTCL Clinical Trial

Official title:

A Retrospective (Non-interventional) Clinical Study on the First-line Maintenance Treatment of Peripheral T-cell Lymphoma (PTCL) With Chidamide.

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT05967949
• Other study ID #: CS123
• Status: Recruiting
• Start date: April 1, 2023
• Est. completion date: April 1, 2028

Study information

• Verified date: July 2023
• Source: The First Affiliated Hospital with Nanjing Medical University
• Contact: wei xu
• Phone: +862568302182
• Email: xuwei10000[@]hotmail.com
• Is FDA regulated: No
• Study type: Observational

Clinical Trial Summary

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

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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 200
• Est. completion date: April 1, 2028
• Est. primary completion date: April 1, 2026
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

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.

Related Conditions & MeSH terms

• PTCL

Intervention

Drug:
• chidamide
This subset of patients received chidamide as first-line maintenance therapy.

Locations

Country	Name	City	State
China	Hematological Department, People's Hospital of Jiangsu Province	Nanjing	Jiangsu

Sponsors (1)

Lead Sponsor	Collaborator
The First Affiliated Hospital with Nanjing Medical University

Country where clinical trial is conducted

China, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	PFS	progression free survival	2 years
Secondary	OS	overall survival	2 years
Secondary	CR	complete remission	2 years
Secondary	DOR	duration of remission	2 years