Study of Purinostat Mesylate for Injection in the Treatment of Relapsed or Refractory Diffuse Lar… (NCT05563844) | Clinical Trial Compass
Active — Not RecruitingPhase 2
Study of Purinostat Mesylate for Injection in the Treatment of Relapsed or Refractory Diffuse Large B-cell Lymphoma (R/R DLBCL)
China74 participantsStarted 2022-11-08
Plain-language 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.
Who can participate
Age range18 Years
SexALL
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Inclusion criteria
✓. Age ≥ 18 years, both males and females are eligible;
✓. Histologically confirmed diffuse large B-cell lymphoma (DLBCL) by tissue biopsy (including primary DLBCL and transformed DLBCL from indolent lymphoma; patients with relapse after more than one year require a repeat tissue biopsy to confirm the pathological diagnosis), and must be relapsed/refractory, specifically defined as: DLBCL patients who have received no more than 5 lines of prior systemic therapy. Relapse includes: 1) relapse occurring more than 6 months after the completion of second-line therapy; 2) relapse occurring more than 3 months after sequential hematopoietic stem cell transplantation following second-line therapy. Refractory includes: 1) primary refractory to first-line standard therapy (i.e., no response to treatment or relapse within 6 months after treatment completion); 2) relapse within 6 months after second-line therapy or failure to achieve partial response (PR) after 2 or more cycles of second-line therapy, or progression during second-line therapy (no specific cycle requirement for refractory patients). Prior treatment must include anti-CD20 monoclonal antibody (unless contraindicated) and anthracycline-based chemotherapy (unless anthracycline is contraindicated). Anti-CD20 monoclonal antibody monotherapy for consolidation or induction does not count as a separate line of therapy. Prior stem cell transplantation is allowed; standalone autologous stem cell transplantation does not count as a line of therapy, as induction, consolidation, stem cell collection, conditioning regimen, and transplantation ± maintenance therapy are considered one line of therapy.
✓. Presence of measurable lesions, defined as: lymph node lesions with the longest diameter \> 15 mm or extranodal lesions with the longest diameter \> 10 mm as measured by contrast-enhanced CT, MRI, or PET-CT; willingness to undergo bone marrow aspiration cytology and/or biopsy for efficacy evaluation if required.
What they're measuring
1
Objective response rate (ORR) of PM
Timeframe: each cycle lasts 21 days, and patients are assessed every 2 cycles until maximum of 2 years.
✓. Prior to the first dose of study treatment, the following intervals must be observed: ≥ 4 weeks since the last systemic radiotherapy; ≥ 2 weeks since local radiotherapy or radiotherapy for bone metastases; no radiopharmaceuticals administered within 8 weeks prior to the first dose of study treatment; ≥ 3 weeks since the last chemotherapy or approved targeted therapy; biological therapy, immunotherapy, and other treatments must be completed at least 4 weeks prior to the first dose of study treatment.
✓. ECOG performance status (Appendix 1) ≤ 2;
✓. Expected survival \> 12 weeks;
✓. Hematological parameters must meet the following criteria: a) Absolute neutrophil count (ANC) ≥ 1.0 × 10\^9/L; b) Hemoglobin (HGB) ≥ 80 g/L; c) Platelet count (PLT) ≥ 75 × 10\^9/L, with no platelet or red blood cell transfusions within 2 weeks prior to screening. Note: If the investigator believes that the patient's laboratory values below the protocol limits are due to bone marrow involvement by lymphoma, the patient's eligibility may be determined after discussion with the sponsor and CRO medical team.
✓. Liver and kidney function test results must meet the following criteria: a) Serum total bilirubin (TBiL) ≤ 1.5 × upper limit of normal (ULN); b) Aspartate aminotransferase (AST), alanine aminotransferase (ALT), and alkaline phosphatase (ALP) ≤ 2.5 × ULN; c) Serum creatinine ≤ 1.5 × ULN. Note: Patients with Gilbert's syndrome may be enrolled if TBiL ≤ 3.0 × ULN; patients with liver involvement by lymphoma may be enrolled if AST, ALT, and ALP ≤ 5 × ULN.
Exclusion criteria
✕. Subjects who meet any of the following criteria will be excluded from the trial:
✕. Known severe allergy to the investigational drug or any of its excipients;
✕. Primary central nervous system lymphoma or lymphoma involving the central nervous system;