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Recruiting NCT05967949

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

Observational PTCL

For patients and families

In plain language

An automatic summary of structured registry data. It is an orientation aid, not a substitute for the official protocol or a physician assessment.

What is being studied
The protocol lists: chidamide.
Who it may be relevant to
Registry conditions: PTCL. Basic parameters: from 18 years · All.
What needs checking
Age, condition and sex are only basic indicators. Prior treatment, laboratory values and other mandatory requirements appear in the eligibility criteria below.
Where it takes place
China
Next step
Save the trial, show it to the treating physician, and confirm current recruitment with the study center. Costs, documents and travel →
Official title

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

Overview

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.

Interventions

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

Primary outcome measures

  • PFS [Time frame: 2 years]
Secondary outcome measures (3)
  • OS [Time frame: 2 years]
  • CR [Time frame: 2 years]
  • DOR [Time frame: 2 years]

Eligibility criteria

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.

Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.

Healthy volunteers: No

Study design

Observational model
Cohort

Study locations

China · 1 center
  • Hematological Department, People's Hospital of Jiangsu Province — Nanjing

Identifiers

NCT: NCT05967949 · CS123

Primary sources (government registries)

View this study on ClinicalTrials.gov ↗