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Chidamide in Patients With Relapsed or Refractory Peripheral T-cell Lymphoma (R/R PTCL) | Clinical Trials | Clareo Health

RECRUITINGPHASE2

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

NCT05833724•Great Novel Therapeutics Biotech & Medicals Corporation

View on ClinicalTrials.gov

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.

Detailed Description

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.

Eligibility

Age

20 - 75 years

Sex

ALL

Healthy Volunteers

Inclusion Criteria

•1. 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.
•2. Patients for whom at least one measurable lesion according to Cheson Criteria 2014 at baseline.
•3. 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.
•4. Male or female, aged 20-75 years (inclusive).
•5. Eastern Cooperative Oncology Group (ECOG) Performance Status of 0 or 1.
•6. With a life expectancy of ≥12 weeks.
•7. Have not received radiotherapy, chemotherapy, immunotherapy (except for antibody therapy), or target therapy within 4 weeks prior to the start of study drug.
•8. Have not received any antibody therapy within 12 weeks prior to the start of study drug.
•9. Willing to provide written informed consent.

Exclusion Criteria

•1. Females who are pregnant or breastfeeding, or females of childbearing potential who are not willing to use adequate contraception.
•2. Patients in whom central nervous system lymphoma is recognized during screening (if suspected clinically, imaging study should be performed to confirm).
•3. Have been treated with histone deacetylase (HDAC) inhibitor.
•4. 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.
•5. The size of fluid area detected by cardiac ultrasonography in cavum pericardium is ≥10 mm during diastolic period.
•6. With a history of organ transplantation.
•7. With a history of allogeneic stem cell transplantation.
•8. Have received autologous stem cell transplantation within 12 weeks prior to the start of study drug.
•9. Have participated in a clinical trial involving investigational antibody therapy within 12 weeks prior to the start of study drug or non-antibody therapy within 4 weeks prior to the start of study drug.
•10. Have received symptomatic treatment for early myelotoxicity within 7 days prior to the start of study drug.
+7 more criteria

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 District, Taiwan

Key Dates

Start Date

October 18, 2024

Primary Completion Date

December 1, 2025

Completion Date

December 1, 2025

Last Updated

March 11, 2025

Enrollment

ESTIMATED participants

Conditions

Relapsed or Refractory Peripheral T-cell Lymphoma

Interventions

Chidamide

DRUG

Contacts

Chia-Nan Chen, Ph.D.

CONTACT

886-2-2785-1399 alex.chen@gntbm.com.tw