Acute Myeloid Leukemia Clinical Trial
Official title:
A Clinical Study to Evaluate the Safety, Efficacy and Pharmacokinetics of Mitoxantrone Hydrochloride Liposome Injection Combined With Chemotherapy in Previously Untreated de Novo Acute Myeloid Leukemia
The purpose of this study is to determine the safety, efficacy and pharmacokinetics of mitoxantrone hydrochloride liposome injection combined with chemotherapy in previously untreated de novo acute myeloid leukemia.
This is a prospective, multi-center, randomized, open-label, three-arm clinical study to explore the efficacy among three chemotherapy regimens combined with mitoxantrone hydrochloride liposome in previously untreated de novo acute myeloid leukemia. Patients will be randomized to different treatment group and be given different induction therapy in the first cycle. If patients do not achieve Morphologic Leukemia-free State (MLFS) after the first induction cycle, they will receive the second induction therapy with mitoxantrone hydrochloride liposome, cytarabine and venetoclax. Mitoxantrone hydrochloride liposome will be given on day 1 at the dose of 24 mg/m2 or 30 mg/m2 and be combined with cytarabine, venetoclax or homoharringtonine. A maximum of 2 cycles of induction therapy are planned. ;
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