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

PHASE3RecruitingINTERVENTIONAL
Enrollment

390

Participants

Timeline

Start Date

July 18, 2025

Primary Completion Date

June 30, 2029

Study Completion Date

June 30, 2029

Conditions
Recurrent and Refractory Diffuse Large B-cell Lymphoma
Interventions
DRUG

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."

DRUG

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.

Trial Locations (1)

610200

RECRUITING

West China Hospital Sichuan University, Chengdu

All Listed Sponsors
lead

Chengdu Zenitar Biomedical Technology Co., Ltd

INDUSTRY