Mitoxantrone Hydrochloride Liposome in Combination With Cytarabine and Venetoclax Regimen in Newly Diagnosed Elderly AML

Inclusion Criteria:

1. Each subject must sign an informed consent form (ICF) indicating that he or sheunderstands the purpose of and procedures required for the study and are willing toparticipate in the study.

2. Aged 60-70 years (including boundary values 60 and 70);

3. Newly diagnosed primary AML according to the WHO 2022 classification.

4. Physical status score of Eastern Oncology Collaboration Group (ECOG) : 0-2.

5. Life expectancy ≥ 3 months.

6. ALT/AST≤2.5 ULN (for subjects with hepatic infiltration≤5 ULN); Total bilirubin≤1.5ULN (for subjects with hepatic infiltration≤3 ULN); Serum creatinine≤1.5 ULN.

Exclusion Criteria:

1. Subjects meet any of the following conditions:

2. Acute promyelocytic leukemia;

3. Secondary AML caused by chemotherapy and/or radiotherapy to treat solid tumoror antecedent hematological disorders such as MDS, MPN, MDS/MPN;

4. AML following blast transformation of prior chronic myeloid leukemia;

5. Central nervous system (CNS) leukemia;

6. Subjects with malignant tumors (excluding cured skin basal cell carcinoma, cervicalcarcinoma in situ, and other malignant tumors that have not been treated andeffectively controlled within the past 5 years) within the past 5 years.

7. Subjects who have received anthracycline pretreatment or other anti-AML treatments (except for hydroxyurea, leukapheresis and other leukocyte-lowering treatments);

8. Subjects who received strong or moderate CYP3A inducers/inhibitors or P-glycoprotein (P-gp) inhibitors within 7 days before starting study treatment;

9. Subjects who are unable to take oral medications or have malabsorption syndrome;

10. Cardiac function and disease conform to one of the following conditions:

11. Long QTc syndrome or QTc interval >480 ms;

12. Complete left bundle branch block, degree II or III atrioventricular block;

13. Severe, uncontrolled arrhythmia requiring medical treatment;

14. New York Heart Association(NYHA) classification ≥ grade II;

15. Cardiac ejection fraction (EF) was less than 50%;

16. A history of myocardial infarction, unstable angina pectoris, severely unstableventricular arrhythmia or any other arrhythmia requiring treatment, a historyof clinically severe pericardial disease, or electrocardiogram evidence ofacute ischemic or active conduction abnormalities within 6 months prior toenrollment;

17. Uncontrolled systemic diseases (such as advanced infections, uncontrolledhypertension, diabetes, etc.);

18. Human immunodeficiency virus (HIV) infection (HIV antibody positive);

19. HBsAg or HBcAb positive, with HBV-DNA≥1x10^3 copies/mL; HCV Ab positive, withHCV-RNA≥1x10^3 copies/mL;

20. A history of immediate or delayed allergy to similar drug and excipients of theinvestigate drug.

21. With a history of severe neurological or psychiatric illness.

22. Not suitable for this study as decided by the investigator.