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

NCT05833724 | Recruiting Phase 2

• 1 other identifier: KEPIDA-2
• Study Type: interventional
• Target: 33
• Locations: 1 country
• Sites: 5

Brief 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.

Conditions

Relapsed or Refractory Peripheral T-cell Lymphoma

Keywords

PTCL

Outcome Measures

Primary Outcomes (1)

• Objective response rate (ORR)

  Objective response rate was defined as the percentage of participants with a complete response (CR) or a partial response (PR) according to International Working Group (IWG) criteria. The response was assessed based on clinical and radiological criteria. CR is defined as the disappearance of all evidence of disease. PR is defined as a regression of measurable disease and no new sites. As pre-defined, the primary endpoint analysis for this study was based on the Independent Overall Efficacy Review Committee (IOERC) assessment of response.

  24 months

Secondary Outcomes (10)

• Time to response (TTR)

  24 months

• Duration of response (DOR)

  24 months

• Progression-free survival (PFS)

  24 months

• Overall survival (OS)

  24 months

• Pharmacokinetics profiles - (AUC0-t)

  Blood samples collected on Days 1-4 and 25-28 of Cycle 1, pre-dose and up to 72 hours post-dose (28 days/cycle)

Study Arms (1)

Chidamide

EXPERIMENTAL

Chidamide tablets orally, twice a week.

Drug: Chidamide

Interventions

Chidamide DRUG

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

Also known as: Tucidinostat, HBI-8000

Chidamide

Eligibility Criteria

• Age: 20 Years - 75 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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).
• Eastern Cooperative Oncology Group (ECOG) Performance Status of 0 or 1.
• With a life expectancy of ≥12 weeks.
• Have not received radiotherapy, chemotherapy, immunotherapy (except for antibody therapy), or target therapy within 4 weeks prior to the start of study drug.
• Have not received any antibody therapy within 12 weeks prior to the start of study drug.
• Willing to provide written informed consent.

You may not qualify if:

• 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.
• The size of fluid area detected by cardiac ultrasonography in cavum pericardium is ≥10 mm during diastolic period.
• With a history of organ transplantation.
• With a history of allogeneic stem cell transplantation.
• Have received autologous stem cell transplantation within 12 weeks prior to the start of study drug.
• 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.
• Have received symptomatic treatment for early myelotoxicity within 7 days prior to the start of study drug.
• With active bleeding or newly diagnosed thromboembolic disease, or with hemorrhagic tendency who are using anticoagulants.
• With active infection of hepatitis B or C, or persistent fever within 14 days prior to the start of study drug.
• With history of testing positive for human immunodeficiency virus or known acquired immunodeficiency syndrome.
• Had a major organ surgery within 6 weeks prior to the start of study drug.
• With abnormal hepatic function (serum total bilirubin \>1.5 x upper limit of normal \[ULN\]; alanine aminotransferase \[ALT\]/aspartate aminotransferase \[AST\] \>2.5 x ULN or \>5 x ULN if liver metastases are present), abnormal renal function (serum creatinine \>1.5 x ULN), or abnormal complete blood count (absolute neutrophil counts \<1500/μL; platelet counts \<90 x 1000/μL, hemoglobin \<9 g/dL).

Sponsors & Collaborators

• Great Novel Therapeutics Biotech & Medicals Corporation: lead

Study Sites (5)

Chang Gung Memorial Hospital, Kaohsiung

Kaohsiung City, Taiwan

NOT YET RECRUITING

Kaohsiung Medical University Chung-Ho Memorial Hospital

Kaohsiung City, Taiwan

RECRUITING

Taichung Veterans General Hospital

Taichung, Taiwan

NOT YET RECRUITING

National Taiwan University Hospital

Taipei, Taiwan

NOT YET RECRUITING

Chang Gung Memorial Hospital, Linkou

Taoyuan District, Taiwan

NOT YET RECRUITING

MeSH Terms

Conditions

Recurrence; Lymphoma, T-Cell, Peripheral

Interventions

N-(2-amino-5-fluorobenzyl)-4-(N-(pyridine-3-acrylyl)aminomethyl)benzamide; HBI-8000

Condition Hierarchy (Ancestors)

Disease Attributes; Pathologic Processes; Pathological Conditions, Signs and Symptoms; Lymphoma, T-Cell; Lymphoma, Non-Hodgkin; Lymphoma; Neoplasms by Histologic Type; Neoplasms; Lymphoproliferative Disorders; Lymphatic Diseases; Hemic and Lymphatic Diseases; Immunoproliferative Disorders; Immune System Diseases

Study Officials

• Chia-Nan Chen, Ph.D.

  Great Novel Therapeutics Biotech & Medicals Corporation

  STUDY DIRECTOR

Central Study Contacts

Chia-Nan Chen, Ph.D.

CONTACT

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

Study Design

• Study Type: interventional
• Phase: phase 2
• Allocation: NA
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: April 17, 2023
• First Posted: April 27, 2023
• Study Start: October 18, 2024
• Primary Completion: December 1, 2025
• Study Completion: December 1, 2025
• Last Updated: March 11, 2025

Record last verified: 2024-12

Locations

TW (5)