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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)

StatusActive, Not Recruiting
PhasePhase 2
Started
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Record History

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  1. Primary completion date: Dec 30, 2025 to Dec 30, 2026
    • Study completion date: Dec 1, 2026 to Dec 1, 2027
    v9
  2. Trial status: Recruiting to Active, Not Recruitingv8 Show 6 more changesShow less
    • Enrollment target: estimated 120 to confirmed 74
    • Primary completion date: Oct 2025 to Dec 30, 2025
    • Study completion date: Dec 1, 2025 to Dec 1, 2026
    • Interventions: PM 11.2 mg/m2 (Drug), PM 8.4 mg/m2 (Drug) to PM 11.2 mg/m^2 (Drug), PM 8.4 mg/m^2 (Drug)
    • Study sites revised (2)
    • Study arms: 1 to 2
  3. Primary endpoints: 5 to 1
    • Secondary endpoints: 1 to 5
    v7
  4. Enrollment target: 30 to 120v6 Show 8 more changesShow less
    • Primary completion date: Oct 2024 to Oct 2025
    • Primary endpoints: 6 to 5
    • Study completion date: May 1, 2025 to Dec 1, 2025
    • Eligibility criteria expanded, about 27 words
    • Study sites revised (2)
    • Study arms: 2 to 1
    • Secondary endpoints expanded, about 1 word
    • Study title expanded, about 4 words
  5. Study sites: 1 to 2v5
Show 3 earlier versionsHide 3 earlier versions
  1. Re-verified, no change to tracked fieldsv4
  2. Trial status: Not Yet Recruiting to Recruiting
    • Primary completion date: Jan 2025 to Oct 2024
    • Start date changed from estimate of Dec 1, 2022 to Nov 8, 2022
    • Site details revised
    v3
  3. Re-verified, no change to tracked fieldsv2
  1. Study First Submitted
  • Stopped: an ongoing trial was terminated, suspended or withdrawn.
  • Notable: the trial’s plan changed such as a big move in its timeline or size, a new primary endpoint, sponsor or phase, or recruiting opened or resumed.
  • Minor: routine progress and housekeeping, such as sites added or enrollment closed.
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.
Trial Details
NCT Number NCT05563844
Lead Sponsor Chengdu Zenitar Biomedical Technology Co., Ltd
Conditions
(from sponsor)		 Diffuse Large B Cell Lymphoma，DLBCL
Related terms Dendritic Cell Sarcoma, Interdigitating
Enrollment 74 participants
Start Date
Primary Completion (estimated)
Study Completion (estimated)
Updated on ClinicalTrials.gov