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

Phase 3

Not yet recruiting

• Conditions: Recurrent and Refractory Diffuse Large B-cell Lymphoma
• Interventions: Drug: Selinexor Tablets; Drug: Purinostat Mesylate for Injection

• Registration Number: NCT07011056
• Lead Sponsor: Chengdu Zenitar Biomedical Technology Co., Ltd

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.

Detailed Description

Not available

Study Timeline

• Status Verified: 2025-05
• Study First Submitted: 2025-05-30
• Study First Submitted QC: 2025-05-30
• Study First Posted: 2025-06-08
• Last Update Submitted: 2025-06-08
• Last Update Posted: 2025-06-12
• Study Start: 2025-06-30
• Primary Completion: 2029-06-30
• Study Completion: 2029-06-30

Recruitment & Eligibility

• Status: NOT_YET_RECRUITING
• Sex: All
• Target Recruitment: 390

Inclusion Criteria

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

Exclusion Criteria

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

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Control group	Selinexor Tablets	-
experimental group	Purinostat Mesylate for Injection	-

Primary Outcome Measures

Name	Time	Method
The Overall Survival	week 96	The Overall Survival

Secondary Outcome Measures

Name	Time	Method
The PFS assessed by BICR AND Investigator according to Lugano 2014	week 96	The PFS assessed by BICR AND Investigator according to Lugano 2014
The ORR assessed by BICR and Investigator according to Lugano 2014	week 96	The ORR assessed by BICR and Investigator according to Lugano 2014