Clinical Trial

Zeprumetostat, Azacitidine Combined With Lipo-MIT in R/R PTCL

Recruiting Phase 2
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Summary
This clinical trial is a Phase II study investigating the effectiveness and safety of a three-drug combination-Zeprumetostat, Azacitidine, and Mitoxantrone Hydrochloride Liposome-in adults with relapsed or refractory peripheral T-cell lymphoma (PTCL). PTCL is an aggressive type of non-Hodgkin lymphoma that has limited treatment options after the first line of therapy. The study aims to enroll approximately 26 patients at a single center in China. Eligible participants will receive up to 6 cycles of induction therapy with all three drugs, followed by up to 2 years of maintenance therapy with Zeprumetostat alone if they respond to treatment. The main goal is to evaluate the overall response rate (how many patients experience tumor shrinkage). Secondary goals include assessing how long patients live without their disease getting worse, how long they survive overall, and the safety profile of this treatment combination. The study will also explore whether specific genetic markers or viral infections are linked to how well patients respond. This study is important because it tests a novel, potentially less toxic, and more effective combination for a patient population with high unmet medical need. All participants will be closely monitored for treatment response and side effects throughout the trial.
Trial Details
NCT Number NCT07372352
Lead Sponsor The First Affiliated Hospital of Soochow University
Conditions Peripheral T Cells Lymphoma (PTCL)
Enrollment 26 participants
Start Date 2026-01-15
Primary Completion 2028-01-15 (estimated)
Study Completion 2029-07-15 (estimated)
Updated on ClinicalTrials.gov 2026-01-28