NCT06485219

A Phase IIa Clinical Study of Purinostat Mesylate for Injection in Patients With Peripheral T-Cell Lymphoma and Cutaneous T-Cell Lymphoma

An Open-Label, Multicenter Phase IIa Clinical Study Evaluating the Safety, Tolerability, Pharmacokinetics, and Preliminary Efficacy of Purinostat Mesylate for Injection for the Treatment of Patients With Relapsed or Refractory Peripheral T-Cell Lymphoma and Cutaneous T-Cell Lymphoma

• Status: Active Not Recruiting
• Phase: Phase 2
• Study type: Interventional
• Enrollment: 50 (estimated)
• Sponsor: Chengdu Zenitar Biomedical Technology Co., Ltd · Industry
• Sex: All
• Age: 18 Years
• Healthy volunteers: Not accepted

Summary

Primary Objective To evaluate the preliminary efficacy of Purinostat Mesylate for Injection in patients with relapsed or refractory Peripheral T-Cell Lymphoma (PTCL) and Cutaneous T-Cell Lymphoma (CTCL). Secondary Objectives 1. To evaluate the safety and tolerability of Purinostat Mesylate for Injection in patients with relapsed or refractory PTCL and CTCL. 2. To evaluate the population pharmacokinetic characteristics of Purinostat Mesylate for Injection in patients with relapsed or refractory PTCL and CTCL. Exploratory Objective To investigate the relationship between tumor biomarkers and the therapeutic efficacy/safety profile of Purinostat Mesylate for Injection.

Conditions

• Relapsed or Refractory Peripheral T-cell Lymphoma (PTCL)
• Cutaneous T-cell Lymphoma (CTCL)

Interventions

Type	Name	Description
DRUG	11.2 mg/m2 Purinostat Mesylate	Purinostat Mesylate for Injection: Intravenous infusion, The subjects were given intravenous drip injections once on D1, D4, D8 and D11 of each dosing cycle, with a dosing cycle lasting for 21 days. The overall duration of the longest administration period shall not exceed 96 weeks.
DRUG	15 mg/m2 Purinostat Mesylate	Purinostat Mesylate for Injection: Intravenous infusion, The subjects were given intravenous drip injections once on D1, D4, D8 and D11 of each dosing cycle, with a dosing cycle lasting for 21 days. The overall duration of the longest administration period shall not exceed 96 weeks.

Timeline

• Start date: 2024-04-14
• Primary completion: 2026-06-30
• Completion: 2026-12-31
• First posted: 2024-07-03
• Last updated: 2026-02-06

Locations

2 sites across 1 country: China