Actively Recruiting

Phase 3
Age: 18Years +
All Genders
NCT07011056

A Phase III Clinical Study of Purinostat Mesylate for Injection in Patients With Diffuse Large B-cell Lymphoma

Led by Chengdu Zenitar Biomedical Technology Co., Ltd · Updated on 2025-09-19

390

Participants Needed

1

Research Sites

206 weeks

Total Duration

On this page

AI-Summary

What this Trial Is About

The main objective of this study is to evaluate the differences in objective response rate and overall survival between the Purinostat mesylate for injection and selinexor, as assessed by blinded independent central review (BICR), in patients with relapsed or refractory diffuse large B-cell lymphoma. .The participants in the experimental group will receive treatment with Purinostat mesylate for injection. The dosage is 11.2 mg/m2. Each administration cycle consists of intravenous administration on days 1, 4, 8, and 11. A 21-day period constitutes one treatment cycle, and the total treatment cycle lasts for 6 cycles. .Participants in the control group will receive selinexor treatment. The recommended dose is 60 mg per dose, taken orally on days 1 and 3 of each week (for example, Monday and Wednesday, or Tuesday and Thursday), and a 4-week period constitutes one treatment cycle.

CONDITIONS

Official Title

A Phase III Clinical Study of Purinostat Mesylate for Injection in Patients With Diffuse Large B-cell Lymphoma

Who Can Participate

Age: 18Years +
All Genders

Eligibility Criteria

Eligible

You may qualify if you...

  • Age 18 years or older, any gender
  • Histologically confirmed diffuse large B-cell lymphoma (DLBCL) with relapse or failure after 2 to 5 prior systemic therapies
  • Measurable disease present
  • ECOG performance status of 0, 1, or 2
  • Adequate organ function as determined by the investigator
Not Eligible

You will not qualify if you...

  • Pregnant or breastfeeding women
  • History of transplantation
  • Diagnosis of double or triple hit B cell lymphoma
  • Known active infection or reactivation of latent infection
  • Presence of any serious diseases deemed unsuitable by the investigator for participation

AI-Screening

AI-Powered Screening

Complete this quick 3-step screening to check your eligibility

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Trial Site Locations

Total: 1 location

1

West China Hospital Sichuan University

Chengdu, Sichuan, China, 610200

Actively Recruiting

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Research Team

L

Liangkun Sun

CONTACT

How is the study designed?

Study Type

INTERVENTIONAL

Masking

NONE

Allocation

RANDOMIZED

Model

PARALLEL

Primary Purpose

TREATMENT

Number of Arms

2

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