Clinical Trial

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

Recruiting Phase 3
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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.
Protocol Amendment History 2 amendments
This ClinicalTrials.gov record has been amended 2 times since 2025-05-30; most recent amendment 2025-09-15.
Status change: Not Yet Recruiting → Recruiting 2025-09-15
Trial Details
NCT Number NCT07011056
Lead Sponsor Chengdu Zenitar Biomedical Technology Co., Ltd
Conditions Recurrent and Refractory Diffuse Large B-cell Lymphoma
Enrollment 390 participants
Start Date 2025-07-18
Primary Completion 2029-06-30 (estimated)
Study Completion 2029-06-30 (estimated)
Updated on ClinicalTrials.gov 2025-09-19