Clinical Study on the Efficacy and Safety of Zeprumetostat, Azacitidine Combined With Mitoxantrone Hydrochloride Liposome in Relapsed/Refractory Peripheral T-Cell Lymphoma.
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.
• Relapsed or refractory peripheral T-cell lymphoma after first-line or higher treatment.
• Age ≥ 18 years.
• Eastern Cooperative Oncology Group (ECOG) performance status score ≤ 2.
• Presence of measurable target lesions \[Note: Target lesions are defined as lesions with at least one longest diameter (LD) measurement \> 1.5 cm and longest perpendicular diameter (LPD) measurement ≥ 1.0 cm, as assessed by computed tomography (CT) or magnetic resonance imaging (MRI). A maximum of six target lesions can be selected\].
• Adequate function of major organs must meet the following criteria:
‣ Hematological parameters: HB ≥ 70 g/L, PLT ≥ 50 × 10\^9/L, NE ≥ 1.0 × 10\^9/L (Note: Patients who have not received transfusions or drugs to support NE, PLT, or HB increase within 1 week before screening are eligible. Patients with bone marrow involvement by lymphoma resulting in cytopenia are not restricted by this criterion).
⁃ Echocardiographic left ventricular ejection fraction ≥ 50%.
⁃ Creatinine ≤ 132 umol/L or creatinine clearance ≥ 60 ml/min.
⁃ ALT and AST ≤ 3 times the upper limit of normal.
• Women of childbearing potential must have a negative pregnancy test. Both male and female patients must agree to use effective contraception during treatment and for 1 year thereafter.
• Life expectancy of more than 3 months.
• Voluntary signed informed consent form.