Mitoxantrone Hydrochloride Liposome, Standard-dose of Cytarabine and Venetoclax in the Treatment of R/R 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. Age ≥18

3. Clinically diagnosed relapsed/refractory AML, excluding acute promyelocyticleukemia.

4. Patients who failed after at least 1 courses of induced treatment.

5. Bone marrow blasts≥5% after CR/CRi, or reappearance of blasts in the blood inat least 2 peripheral blood samples at least one week apart, or leukemia cellinfiltration appeared in extramedullary.

6. Conversion from MRD negativity to MRD positivity after CR/CRi.

7. Physical status score of Eastern Oncology Collaboration Group (ECOG) 2-3 forpatients whose age ≤65, or 0-2 for patients whose age >65.

8. Life expectancy > 3 months.

9. AST/ALT≤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. Previous anti-tumor therapy meets one of the following criteria:

2. Prior therapy with mitoxantrone or mitoxantrone liposome;

3. Prior therapy with doxorubicin or anthracyclines, and the cumulative dose ofdoxorubicin > 360 mg/m^2 (1 mg doxorubicin was equivalent to 2 mg daunorubicinor 0.5 mg idarubicin);

4. Have received other anti-tumor therapy (including chemotherapy, targetedtherapy, hormone therapy, Chinese medicines with anti-tumor activity, exceptthose that do not affect the efficacy of the study as determined by theinvestigator) or participated in other clinical trials and received clinicaltrial drugs within 4 weeks or 5 half-lives of the drug before the study;

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

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

7. Cardiovascular diseases, including but not limited to:

8. QTc interval >480 ms or long QTc syndrome in screening;

9. Complete left bundle branch block, 2 or 3 grade atrioventricular block;

10. Requiring treatment of serious and uncontrolled arrhythmia;

11. New York Heart Association NYHA≥2;

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

13. Myocardial infarction, unstable angina pectoris, severe unstable ventriculararrhythmia or any other history of arrhythmia or clinically serious pericardialdisease that requires treatment within the first 6 months of enrollment, orelectrocardiographic evidence of acute ischemic or active conduction systemabnormalities.

14. Central nervous system leukemia;

15. Previous or current occurrence of other malignancies (in addition to non-melanomabasal cell carcinoma of the skin that is effectively controlled, breast/cervicalcarcinoma in situ, and other malignancies that have been effectively controlledwithout treatment within the past five years).

16. Subjects are suffering from any other uncontrollable disease (including but notlimited to: uncontrolled diabetes and hypertension, and advanced infection);

17. HIV infection.

18. HBsAg or HBcAb positive, with HBV-DNA≥1x103 copies/mL; or HCV-RNA≥1x103 copies/mL;

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

20. Pregnant, lactating female or subjects who refuse to use effective contraceptionduring the study.

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

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