Clinical Study of Mitoxantrone Hydrochloride Liposome Injection in Subjects With Acute Myeloid Leukemia
Status:
Recruiting
Trial end date:
2026-05-01
Target enrollment:
Participant gender:
Summary
This study is an open-label, single-arm, phase I/II clinical study. Phase I is a
multi-center, dose-escalation study, aiming to explore the maximum tolerated dose (MTD) of
venetoclax combined with mitoxantrone liposome in the treatment of relapsed or refractory
acute myeloid leukemia (AML), and determine the recommended dose for phase II (RP2D); Phase
II is a multi-center, exploratory study, aiming to explore efficacy of venetoclax combined
with mitoxantrone liposome in the treatment of relapsed and refractory AML patients, and to
explore the differences in the efficacy of this combination therapy with different gene
mutations.