drugset / Trial / NCT05100303
A Study to Evaluate the Tolerance and Efficacy of Mitoxantrone Hydrochloride Liposome Injection Combined With Cytarabine in Patients With Acute Myeloid Leukemia (AML)
NaSingle-groupOpen-labelTreatment
Summary
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.
Timeline
- Start
- 2021-12
- Primary completion
- 2022-11
- Completion
- 2023-06
Drugs
| Evaluation | Drug | Modality | Dose | Route |
|---|---|---|---|---|
| Subject | Cytarabine | Small molecule | 100 mg/m2 | Intravenous |
| Subject | Cytarabine | Small molecule | 200 mg/m2 | Intravenous |
| Subject | Cytarabine | Small molecule | 1.5 g | Intravenous |
| Subject | Mitoxantrone | Small molecule | 24 mg/m2 | Intravenous |
| Subject | Mitoxantrone | Small molecule | 30 mg/m2 | Intravenous |
| Subject | Mitoxantrone | Small molecule | 36 mg/m2 | Intravenous |