Treatment-naive or Relapsed or Refractory Acute Myeloid Leukemia (AML) Clinical Trial
Official title:
An Open-label, Multi-center Phase Ib/II Study to Evaluate the Tolerance and Efficacy of Mitoxantrone Hydrochloride Liposome Injection Combined With Cytarabine in Patients With Acute Myeloid Leukemia (AML)
This is an open-label, multi-cohort, multi-center Phase Ib/II clinical study to evaluate the tolerance and efficacy of Mitoxantrone Hydrochloride liposome injection combined with cytarabine in patients with Acute Myeloid Leukemia (AML). The study will be divided into two phases, the dose escalation phase and the dose expansion phase. Patients with relapsed or refractory(R/R) AML will be included in the dose-escalation phase, and patients with treatment-naïve or R/R AML will be included in the dose-expansion phase.
Dose escalation phase: Eligible patients will enter the screening period up to 14 days before the start of treatment. Patients will receive mitoxantrone liposomes combined with cytarabine, with a fixed dose of cytarabine and mitoxantrone liposomes in 3 dose groups: 24 mg/m^2, 30 mg/m^2 and 36 mg/m^2. The starting dose will be 24 mg/m^2, and the "3+3" principle is adopted for the escalation. If the maximum tolerated dose is not explored at the preset maximum dose (36 mg/m^2), the investigator and the sponsor will determine whether to continue the dose escalation, and it is necessary to ensure that 6 patients complete the dose-limiting toxicity (DLT) observation under this dose group. The treatment period includes 2 cycles with each cycle lasting 28 days. Cycle 1 is the DLT observation period and Cycle 2 is the extended dosing period. Mitoxantrone hydrochloride liposome injection will be given on the first day of each cycle, and cytarabine will be given every 12 hours on Day 1, 3, and 5 of each cycle. Patients who do not experience a DLT in the first cycle and achieve is at least PR, may enter the extended dosing period and be treated with the original regimen in Cycle 2. Patients who have completed 2 cycles and have a DLT in the first cycle or have not achieved PR will be withdrawn from treatment. Dose expansion phase: Newly treated AML or R/R AML patients will be included and divided into two cohorts. Eligible patients will enter the screening period up to 14 days before receiving treatments. The treatment period is 2 cycles, and each cycle is 28 days. Mitoxantrone hydrochloride liposome injection will be given on the first day of each cycle, whose dose size will be determined by the investigator and the sponsor based on the results of the previous study. Cytarabine will be given on Day 1-7 of each cycle for the treatment-naïve group, and on Day 1, 3 and 5 of each cycle for the R/R group. Patients will take 1 cycle of therapy and will be assessed for response at the end of the 1st cycle. After the efficacy evaluation, the patient may receive a second cycle of chemotherapy at the investigator's discretion. And patients whose curative effect do not reach PR will be withdrawn from treatment. ;