NCT05563844

Study of Purinostat Mesylate for Injection in the Treatment of Relapsed or Refractory Diffuse Large B-cell Lymphoma (R/R DLBCL)

An Open-label, Multi-center Phase II Clinical Study on the Efficacy and Safety of Purinostat Mesylate for Injection in the Treatment of Relapsed or Refractory Diffuse Large B-cell Lymphoma (DLBCL)

• Status: Active Not Recruiting
• Phase: Phase 2
• Study type: Interventional
• Enrollment: 74 (actual)
• Sponsor: Chengdu Zenitar Biomedical Technology Co., Ltd · Industry
• Sex: All
• Age: 18 Years
• Healthy volunteers: Not accepted

Summary

Purinostat mesylate for injection (PM) was the novel and highly potent Class Ia and IIb HDAC selective inhibitor. The results of regular blood sampling analysis of the mouse B-cell lymphoma model induced by ighmyc transgenic mice showed that the treatment of PM in each group reduced the proportion of peripheral blood tumor cells in mice. Therefore, PM has the potential to treat diffuse large B cell lymphoma. Compared with the blank control group, the body weight of the tumor-bearing animals in each dose of PM group did not decrease significantly during the treatment process, and the animals were in good condition during the whole experiment, indicating that the PM is efficacious and safe. Main purpose: To further explore the safe and effective dose of purinostat mesylate for injection in the treatment of relapsed or refractory diffuse large B-cell lymphoma. To evaluate the objective response rate (ORR) of purinostat mesylate for injection in the treatment of relapsed or refractory diffuse large B-cell lymphoma. Secondary purpose: To evaluate the time to tumor response (TTR), duration of response (DOR), disease control rate (DCR), and progression-free survival (PFS) in the treatment of relapsed or refractory diffuse large B-cell lymphoma with purinostat mesylate for injection ), overall survival (OS). Assessing the safety and tolerability of purinostat mesylate for injection in the treatment of relapsed or refractory diffuse large B-cell lymphoma. Exploratory purpose: To explore the biomarkers related to the efficacy of purinostat mesylate for injection.

Conditions

• Diffuse Large B Cell Lymphoma，DLBCL

Interventions

Type	Name	Description
DRUG	PM 8.4 mg/m^2	The medication is administered once via intravenous infusion on days 1, 4, 8, and 11 of each 21-day treatment cycle. A total of 6 cycles are planned, with tumor response assessments performed every 2 cycles during the treatment period.
DRUG	PM 11.2 mg/m^2	The medication is administered once via intravenous infusion on days 1, 4, 8, and 11 of each 21-day treatment cycle. A total of 6 cycles are planned, with tumor response assessments performed every 2 cycles during the treatment period.

Timeline

• Start date: 2022-11-08
• Primary completion: 2026-12-30
• Completion: 2027-12-01
• First posted: 2022-10-03
• Last updated: 2026-02-04

Locations

2 sites across 1 country: China