A Study of Mitoxantrone Hydrochloride Liposome Injection in Subjects With Acute Myeloid Leukemia

Exclusion Criteria

• •1\. AML occurs in any of the following situations:
• •1. Acute promyelocytic leukemia;
• •2. Chronic myeloid leukaemia in blast crisis;
• •3. Central nervous system (CNS) involvement with AML; 2. Subjects has been previously diagnosed with other malignant tumors in the past 5 years (except curable tumors such as basal cell carcinoma of the skin and carcinoma in situ of the cervix); 3. Graft-versus-host disease requiring ongoing treatment and having received more than one allogeneic stem cell transplant.
• •4\. History of allergy to mitoxantrone hydrochloride injection or liposomal drugs; 5. Previous treatment with doxorubicin or other anthracycline and a cumulative dose of doxorubicin in excess of 400mg/m\^2 (anthracycline equivalent dose calculation: 1 mg doxorubicin =2 mg epirubicin = 2 mg daunorubicin = 0.5 mg idarubicin = 0.45 mg mitoxantrone; Adriamycin liposomes excepted); 6. Received any antineoplastic therapy within 2 weeks prior to initial administration (or within 5 half-lives of the drug). Except for leukocyte lowering therapy (hydroxyurea, leukocyte separation, etc.) and prophylactic intrathecal injection which are over 24 hours prior to administration; 7.The non-hematologic toxicity of previous anti-tumor treatment \> Grade 1 based on CTCAE (except for alopecia, skin pigmentation or tolerable events judged by the investigator); 8. Those on systemic anti-infective therapy with poorly controlled infection (signs of infection progression within 1 week prior to the first dose, or as determined by the investigator); 9. Life expectancy \< 3 months; 10. Cardiovascular diseases, including but not limited to:
• •1. QTc interval \>480 ms or long QTc syndrome in screening;
• •2. Complete left bundle branch block, severe atrioventricular block (without pacemaker);
• •3. Requiring treatment of serious and uncontrolled arrhythmias, unstable angina pectoris, valvular disease, etc;
• •4. Have a history of chronic congestive heart failure, New York Heart Association（NYHA）≥3; or persistent cardiomyopathy;
• •5. Uncontrolled hypertension (defined as multiple measurements of systolic blood pressure \>150 mmHg or diastolic blood pressure \>90 mmHg under medication control);
• •6. ECG evidence of myocardial infarction, viral myocarditis, history of severe pericardial disease, acute ischemic or active conduction system abnormalities within 6 months prior to screening; 11. Severe thrombosis or thromboembolism in the past 6 months, including but not limited to cerebrovascular accident (including transient ischemic attack, etc.), upper/lower vena cava thrombosis, lower extremity deep vein thrombosis, pulmonary embolism, etc; 12. HBsAg or HBcAb positive, with HBV DNA≥2000 IU/mL, or HCV antibody positive with HCV RNA higher than the lower limit of the detection value of the research center, or HIV antibody positive in the preliminary screening; 13. Subjects are suffering from any other serious and/or uncontrollable disease that, in the judgment of the investigator, may affect the patient's participation in this study (including but not limited to: uncontrolled diabetes, kidney disease requiring dialysis treatment, severe liver diseases, life-threatening autoimmune disease and hemorrhagic disease, drug abuse, nervous system diseases, etc.); 14. Pregnant or lactating female; 15. Not suitable for this study as decided by the investigator due to other reasons