RecruitingPhase 3NCT07011056

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

A Randomized, Controlled, Multicenter Phase III Clinical Study Evaluating the Efficacy and Safety of the Purinostat Mesylate for Injection (PM) Compared to Selinexor in Patients With Relapsed/Refractory Diffuse Large B-cell Lymphoma (R/R DLBCL)


Sponsor

Chengdu Zenitar Biomedical Technology Co., Ltd

Enrollment

390 participants

Start Date

Jul 18, 2025

Study Type

INTERVENTIONAL

Conditions

Summary

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.


Eligibility

Min Age: 18 Years

Plain Language Summary

Simplified for easier understanding

This trial is testing a drug called purinostat mesylate (an HDAC inhibitor — a type of drug that can switch cancer cell genes back to normal) for patients with diffuse large B-cell lymphoma (DLBCL) that has relapsed or stopped responding to prior treatments. **You may be eligible if...** - You are 18 or older - You have been confirmed to have DLBCL by a tissue biopsy - Your lymphoma has come back or failed to respond to at least 2 prior treatment regimens - You have measurable disease on a scan and your organs are functioning adequately **You may NOT be eligible if...** - You are pregnant or breastfeeding - You have had a prior stem cell transplant - Your lymphoma is classified as double or triple-hit B-cell lymphoma - You have an active infection or an uncontrolled serious illness Talk to your doctor to see if this trial is right for you.

This summary was AI-generated to explain the trial in plain language. It is not medical advice. Always discuss eligibility with your doctor before enrolling in a clinical trial.

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Interventions

DRUGPurinostat Mesylate for Injection

The subjects 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 infusion on days 1, 4, 8, and 11. The administration cycle lasts for 21 days, and the total treatment cycle is 6 cycles. After 6 cycles, the investigator will assess whether the subjects can continue to benefit, whether they can sustain the treatment with the investigational drug, and adjust the frequency of continuous administration based on the evaluation results of the efficacy over these 6 cycles.

DRUGSelinexor Tablets

The recommended dose of selinexor tablets is 60 mg per administration, taken orally on the 1st and 3rd day of each week (for example, Monday and Wednesday, or Tuesday and Thursday), with a 4-week course as one treatment cycle. Patients who achieve partial response (judged by the investigator as the best expected response for the subject) or have better efficacy can switch to maintenance treatment, with a maintenance dose of 60 mg taken orally once a week.


Locations(1)

West China Hospital Sichuan University

Chengdu, Sichuan, China

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NCT07011056