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

NCT07011056 | Recruiting Phase 3 DMC

• 1 other identifier: ZLPM-001-2.0
• Study Type: interventional
• Target: 390
• Locations: 1 country
• Sites: 1

Brief 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.

Conditions

Recurrent and Refractory Diffuse Large B-cell Lymphoma

Outcome Measures

Primary Outcomes (1)

• The Overall Survival

  The Overall Survival

  week 96

Secondary Outcomes (2)

• The PFS assessed by BICR AND Investigator according to Lugano 2014

  week 96

• The ORR assessed by BICR and Investigator according to Lugano 2014

  week 96

Study Arms (2)

Control group

ACTIVE COMPARATOR

Drug: Selinexor Tablets

experimental group

EXPERIMENTAL

Drug: Purinostat Mesylate for Injection

Interventions

Purinostat Mesylate for Injection DRUG

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.

experimental group

Selinexor Tablets DRUG

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.

Control group

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Age ≥ 18 years, no gender restrictions;
• Histologically-confirmed DLBCL, Participants must have relapsed or failed to respond to at least two lines of prior systemic therapy (2-5 lines);
• Participants must have measurable disease;
• ECOG≤2;
• Adequate organ function

You may not qualify if:

• Pregnancy or breastfeeding;
• Previous history of transplantation;
• Double/Triple Hit B cell lymphoma;
• Patient with known active infection, or reactivation of a latent infection;
• Any serious diseases that investigator deems inappropriate to participate.

Sponsors & Collaborators

• Chengdu Zenitar Biomedical Technology Co., Ltd: lead

Study Sites (1)

West China Hospital Sichuan University

Chengdu, Sichuan, 610200, China

RECRUITING

MeSH Terms

Conditions

Recurrence; Lymphoma, Large B-Cell, Diffuse

Interventions

Injections; selinexor

Condition Hierarchy (Ancestors)

Disease Attributes; Pathologic Processes; Pathological Conditions, Signs and Symptoms; Lymphoma, B-Cell; Lymphoma, Non-Hodgkin; Lymphoma; Neoplasms by Histologic Type; Neoplasms; Lymphoproliferative Disorders; Lymphatic Diseases; Hemic and Lymphatic Diseases; Immunoproliferative Disorders; Immune System Diseases

Intervention Hierarchy (Ancestors)

Drug Administration Routes; Drug Therapy; Therapeutics

Central Study Contacts

Liangkun Sun

CONTACT

86+15885742617; liangkunsun@zenitar.cn

Study Design

• Study Type: interventional
• Phase: phase 3
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: May 30, 2025
• First Posted: June 8, 2025
• Study Start: July 18, 2025
• Primary Completion (Estimated): June 30, 2029
• Study Completion (Estimated): June 30, 2029
• Last Updated: September 19, 2025

Record last verified: 2025-09

Data Sharing

• IPD Sharing: Will not share

Locations

CN (1)