Mitoxantrone Hydrochloride Liposome Injection, Cytarabine Combined With Venetoclax in the Treatment of R/R AML

Exclusion Criteria

• •1. Previous anti-tumor therapy meets one of the following criteria:
• •1. Prior therapy with mitoxantrone or mitoxantrone liposome;
• •2. Prior therapy with doxorubicin or anthracyclines, and the cumulative dose of doxorubicin \> 360 mg/m\^2 (1 mg doxorubicin was equivalent to 2 mg daunorubicin or 0.5 mg idarubicin);
• •3. Have received other anti-tumor therapy (including chemotherapy, targeted therapy, hormone therapy, Chinese medicines with anti-tumor activity, except those that do not affect the efficacy of the study as determined by the investigator) or participated in other clinical trials and received clinical trial drugs within 4 weeks or 5 half-lives of the drug before the study;
• •2. Cardiovascular diseases, including but not limited to:
• •1. QTc interval \>480 ms or long QTc syndrome in screening;
• •2. Complete left bundle branch block, 2 or 3 grade atrioventricular block;
• •3. Requiring treatment of serious and uncontrolled arrhythmia;
• •4. New York Heart Association（NYHA≥3;
• •5. Cardiac ejection fraction (EF) was less than 50%;
• •6. Myocardial infarction, unstable angina pectoris, severe unstable ventricular arrhythmia or any other history of arrhythmia or clinically serious pericardial disease that requires treatment within the first 6 months of enrollment, or electrocardiographic evidence of acute ischemic or active conduction system abnormalities.
• •3. Central nervous system leukemia;
• •4. Previous or current occurrence of other malignancies (in addition to non-melanoma basal cell carcinoma of the skin that is effectively controlled, breast/cervical carcinoma in situ, and other malignancies that have been effectively controlled without treatment within the past five years).
• •5. Subjects are suffering from any other uncontrollable disease (including but not limited to: uncontrolled diabetes and hypertension, and advanced infection);
• •6. HIV infection.
• •7. HBsAg or HBcAb positive, with HBV-DNA≥1x10\^3 copies/mL; or HCV-RNA≥1x10\^3 copies/mL;
• •8. A history of immediate or delayed allergy to similar drug and excipients of the investigate drug.
• •9. Pregnant, lactating female or subjects who refuse to use effective contraception during the study.
• •10. With a history of severe neurological or psychiatric illness.
• •11. Not suitable for this study as decided by the investigator.