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

Great Novel Therapeutics Biotech & Medicals Corporation5 sites in 1 country33 target enrollmentOctober 18, 2024

ConditionsRelapsed or Refractory Peripheral T-cell Lymphoma

InterventionsChidamide

DrugsChidamide

Overview

Phase: Phase 2
Intervention: Chidamide
Conditions: Relapsed or Refractory Peripheral T-cell Lymphoma
Sponsor: Great Novel Therapeutics Biotech & Medicals Corporation
Enrollment: 33
Locations: 5
Primary Endpoint: Objective response rate (ORR)
Status: Recruiting
Last Updated: last year

Overview Investigators Eligibility Criteria Arms & Interventions Outcomes Sites Similar Trials

Overview

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.

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.

Registry

clinicaltrials.gov

Start Date

October 18, 2024

End Date

December 2025

Last Updated

last year

Study Type

Interventional

Study Design

Single Group

Sex

All

Investigators

Sponsor

Great Novel Therapeutics Biotech & Medicals Corporation

Responsible Party

Sponsor

Eligibility Criteria

Inclusion Criteria

•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
•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.

Exclusion Criteria

•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.

Arms & Interventions

Chidamide

Chidamide tablets orally, twice a week.

Intervention: Chidamide

Outcomes

Primary Outcomes

Objective response rate (ORR)

Time Frame: 24 months

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.

Secondary Outcomes

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))
Pharmacokinetics profiles - (AUC0-∞)(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))
Pharmacokinetics profiles - (Cmax)(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))
Pharmacokinetics profiles - (Tmax)(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))
Pharmacokinetics profiles - (T1/2)(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))
Pharmacokinetics profiles - (Ctrough)(PK samples collected on Day 15, Day 18, and Day 22 predose (28 days/cycle))
Time to response (TTR)(24 months)