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

NCT06485219 · Status: ACTIVE_NOT_RECRUITING · Phase: PHASE2 · Type: INTERVENTIONAL · Enrollment: 50

Last updated 2026-02-06

No results posted yet for this study

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

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.

Sponsors & Collaborators

  • Chengdu Zenitar Biomedical Technology Co., Ltd

    lead INDUSTRY

Principal Investigators

  • Ting Niu, Doctor · West China Hospital

  • Weili Zhao, Doctor · Ruijin Hospital

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
NONE
Model
PARALLEL

Eligibility

Min Age
18 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2024-04-14
Primary Completion
2026-06-30
Completion
2026-12-31

Countries

  • China

Study Locations

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Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT06485219 on ClinicalTrials.gov