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

NCT05563844 · Status: ACTIVE_NOT_RECRUITING · Phase: PHASE2 · Type: INTERVENTIONAL · Enrollment: 74

Last updated 2026-02-04

No results posted yet for this study

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

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.

Sponsors & Collaborators

  • Chengdu Zenitar Biomedical Technology Co., Ltd

    lead INDUSTRY

Principal Investigators

  • Ting Niu, Doctor · West China Hospital

  • Weili Zhao, Doctor · Ruijin Hospital

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
NONE
Model
SEQUENTIAL

Eligibility

Min Age
18 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2022-11-08
Primary Completion
2026-12-30
Completion
2027-12-01

Countries

  • China

Study Locations

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Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT05563844 on ClinicalTrials.gov