NCT05833724

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

• Status: Recruiting
• Phase: Phase 2
• Study type: Interventional
• Enrollment: 33 (estimated)
• Sponsor: Great Novel Therapeutics Biotech & Medicals Corporation · Industry
• Sex: All
• Age: 20 Years – 75 Years
• Healthy volunteers: Not accepted

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.

Conditions

• Relapsed or Refractory Peripheral T-cell Lymphoma

Interventions

Type	Name	Description
DRUG	Chidamide	Subjects will receive a single dose of 30 mg chidamide. Twice a week.

Timeline

• Start date: 2024-10-18
• Primary completion: 2025-12-01
• Completion: 2025-12-01
• First posted: 2023-04-27
• Last updated: 2025-03-11

Locations

5 sites across 1 country: Taiwan