Overview

A Study to Evaluate the Tolerance and Efficacy of Mitoxantrone Hydrochloride Liposome Injection Combined With Cytarabine in Patients With Acute Myeloid Leukemia (AML)

Status:
Not yet recruiting

Trial end date:
2023-06-01

Target enrollment:

Participant gender:

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.

Phase:

Phase 1/Phase 2

Details

Lead Sponsor:

CSPC ZhongQi Pharmaceutical Technology Co., Ltd.

Treatments:

Cytarabine
Mitoxantrone