Recruiting

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

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What is being tested

Chidamide

Drug
Who is being recruted

Hemic and Lymphatic Diseases+12

+ Immune System Diseases

+ Immunoproliferative Disorders

From 20 to 75 Years
+26 Eligibility Criteria
See all eligibility criteria
How is the trial designed

Treatment Study

Phase 2
Interventional
Study Start: October 2024
See protocol details

Summary

Principal SponsorGreat Novel Therapeutics Biotech & Medicals Corporation
Study ContactChia-Nan Chen, Ph.D.
Last updated: January 28, 2026
Sourced from a government-validated database.Claim as a partner

Study start date: October 18, 2024

Actual date on which the first participant was enrolled.

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. To determine eligibility, subjects must have PTCL confirmed with a sample or specimen evaluated by the investigator.A treatment cycle is defined as 4 weeks. All eligible subjects will be treated with chidamide until disease progression, intolerable toxicity effects, death, or withdrawal of consent.

Official TitleA Phase II, Open-label, Single-arm, Multicenter Study of Chidamide in Patients With Relapsed or Refractory Peripheral T-cell Lymphoma
NCT05833724
Principal SponsorGreat Novel Therapeutics Biotech & Medicals Corporation
Study ContactChia-Nan Chen, Ph.D.
Last updated: January 28, 2026
Sourced from a government-validated database.Claim as a partner

Protocol

This section provides details of the study plan, including how the study is designed and what the study is measuring.
Design Details

33 patients to be enrolled

Total number of participants that the clinical trial aims to recruit.

Treatment Study

These studies test new ways to treat a disease, condition, or health issue. The goal is to see if a new drug, therapy, or approach works better or has fewer side effects than existing options.

Eligibility

Researchers look for people who fit a certain description, called eligibility criteria: person's general health condition or prior treatments.
Conditions
Criteria

Any sex

Biological sex of participants that are eligible to enroll.

From 20 to 75 Years

Range of ages for which participants are eligible to join.

Healthy volunteers not allowed

If individuals who are healthy and do not have the condition being studied can participate.

Conditions

Pathology

Hemic and Lymphatic DiseasesImmune System DiseasesImmunoproliferative DisordersLymphatic DiseasesLymphomaLymphoma, Non-HodgkinLymphoproliferative DisordersNeoplasmsNeoplasms by Histologic TypePathologic ProcessesRecurrencePathological Conditions, Signs and SymptomsLymphoma, T-CellLymphoma, T-Cell, PeripheralDisease Attributes

Criteria

9 inclusion criteria required to participate
Histopathological diagnosis, made by the investigator, of the following PTCL subtypes as defined by the WHO classification (2016) may be included: PTCL, not otherwise specified (PTCL-NOS), anaplastic lymphoma kinase-positive (ALK+) anaplastic large-cell lymphoma (ALCL), ALK-negative (ALK-) ALCL, angioimmunoblastic T-cell lymphoma (AITL), extranodal natural killer (NK)/T-cell lymphoma, nasal type (ENKL), etc., except cutaneous form or leukemic form.
Patients for whom at least one measurable lesion according to Cheson Criteria 2014 at baseline.
Relapsed or refractory disease (including DOR shorter than 30 days) to ≥1 prior systemic therapy including, but not limited to, chemotherapy, target therapy, immunotherapy, and autologous stem cell transplantation.
Male or female, aged 20-75 years (inclusive).
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17 exclusion criteria prevent from participating
Females who are pregnant or breastfeeding, or females of childbearing potential who are not willing to use adequate contraception.
Patients in whom central nervous system lymphoma is recognized during screening (if suspected clinically, imaging study should be performed to confirm).
Have been treated with histone deacetylase (HDAC) inhibitor.
With a history of clinically significant QTc prolongation (>450 ms for males or >470 ms for females), ventricular tachycardia (VT), atrial fibrillation (AF), heart block (HB), myocardial infarction (MI) onset within one year, congestive heart failure (CHF), or any other symptomatic coronary artery disease requiring treatment.
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Study Plan

Find out more about all the medication administered in this study, their detailed description and what they involve.
Treatment Groups
Study Objectives

One single intervention group is designated in this study

This study does not include a placebo group 

Treatment Groups

Group I

Experimental
Chidamide tablets orally, twice a week.

Study Objectives

Primary Objectives

Secondary Objectives

Study Centers

These are the hospitals, clinics, or research facilities where the trial is being conducted. You can find the location closest to you and its status.

This study has 5 locations

Recruiting

Kaohsiung Medical University Chung-Ho Memorial Hospital

Kaohsiung City, TaiwanOpen Kaohsiung Medical University Chung-Ho Memorial Hospital in Google Maps
Recruiting soon

Chang Gung Memorial Hospital, Kaohsiung

Kaohsiung City, Taiwan
Recruiting soon

Taichung Veterans General Hospital

Taichung, Taiwan
Recruiting soon

National Taiwan University Hospital

Taipei, Taiwan
Recruiting
5 Study Centers