RecruitingPhase 2NCT05833724

Chidamide in Patients With Relapsed or Refractory Peripheral T-cell Lymphoma (R/R PTCL)

A Phase II, Open-label, Single-arm, Multicenter Study of Chidamide in Patients With Relapsed or Refractory Peripheral T-cell Lymphoma


Sponsor

Great Novel Therapeutics Biotech & Medicals Corporation

Enrollment

33 participants

Start Date

Oct 18, 2024

Study Type

INTERVENTIONAL

Conditions

Summary

This is a phase II, open-label, non-randomized, single-arm, multicenter study to evaluate the efficacy, safety, and PK of chidamide in patients with R/R PTCL.


Eligibility

Min Age: 20 YearsMax Age: 75 Years

Plain Language Summary

Simplified for easier understanding

This study is testing a drug called chidamide — a type of medication that affects how cancer genes are switched on or off — in patients with relapsed or refractory peripheral T-cell lymphoma (a type of blood cancer that has come back or stopped responding to treatment). The goal is to find out how effective and safe chidamide is for this difficult-to-treat cancer. **You may be eligible if...** - You are between 20 and 75 years old - You have been diagnosed with one of several types of T-cell lymphoma confirmed by biopsy - Your lymphoma has relapsed or is no longer responding to at least one prior treatment - Your general health is good enough to participate (ECOG score 0–1) - You have at least one measurable tumor site **You may NOT be eligible if...** - You have received a similar type of drug called an HDAC inhibitor before - You are pregnant or breastfeeding - Your lymphoma has spread to the brain - You have a history of serious heart rhythm problems or heart failure Talk to your doctor to see if this trial is right for you.

This summary was AI-generated to explain the trial in plain language. It is not medical advice. Always discuss eligibility with your doctor before enrolling in a clinical trial.

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Interventions

DRUGChidamide

Subjects will receive a single dose of 30 mg chidamide. Twice a week.


Locations(5)

Chang Gung Memorial Hospital, Kaohsiung

Kaohsiung City, Taiwan

Kaohsiung Medical University Chung-Ho Memorial Hospital

Kaohsiung City, Taiwan

Taichung Veterans General Hospital

Taichung, Taiwan

National Taiwan University Hospital

Taipei, Taiwan

Chang Gung Memorial Hospital, Linkou

Taoyuan, Taiwan

View Full Details on ClinicalTrials.gov

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NCT05833724