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Clinical Trials in China / NCT07011056
Recruiting Phase 3

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

NCT07011056 · tracked via the Priya Life Science China tracker
Sponsor
Chengdu Zenitar Biomedical Technology Co., Ltd
Phase
Phase 3
Started
2025-07-18
Last updated
2025-09-19

Condition(s) studied

Recurrent and Refractory Diffuse Large B-cell Lymphoma

Investigational drug(s) / intervention(s)

Purinostat Mesylate for InjectionSelinexor Tablets

Purinostat 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.

Selinexor 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.

Study 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

Sex
ALL
Min age
18 Years
Max age
Healthy volunteers
No
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.

Primary outcome measure(s)

Trial sites (1)

FacilityCityRegionStatus
West China Hospital Sichuan University Chengdu Sichuan Recruiting

More Chengdu Zenitar Biomedical Technology Co., Ltd trials in China

Official registry record

This page summarises publicly available registry data for informational purposes — not medical advice. Eligibility is determined by each study team; patients should discuss participation with their clinician.

View NCT07011056 on ClinicalTrials.gov ↗ ← All trials in China