Mitoxantrone Hydrochloride Liposome Combined With Chemotherapy in Untreated de Novo Acute Myeloid Leukemia

Inclusion Criteria:

1. Able to understand the study and voluntarily sign informed consent.

2. Age: 18~65 (including 18) years old, gender unlimited.

3. Patients diagnosed with acute myeloid leukemia according to "The 2016 revision tothe World Health Organization classification of myeloid neoplasms and acuteleukemia" who haven't been treated.

4. Eastern Cooperative Oncology Group (ECOG) physical state score: 0-1.

5. Fit for intensive chemotherapy.

6. The function of main organs should meet the following standards before treatment: Kidney: Serum creatinine ≤ 1.5 × Upper limit of normal range (ULN) Liver: Totalbilirubin ≤ 1.5 × ULN, AST and ALT ≤ 3× ULN

7. Patients should agree to use contraception (such as intrauterine device [IUD],contraceptive pill or condom) during the study period and within 6 months after theend of the study; Female patients must have a negative serum pregnancy test within 7days before enrollment.

Exclusion Criteria:

1. Any of the following cases:(1) diagnosed as acute promyelocytic leukemia (APL);(2)chronic myelogenous leukemia in blast crisis;(3) AML with central nervous systemleukemia.

2. AML arising from prior cytotoxic chemotherapy or radiotherapy for other tumours.

3. Patient has been previously diagnosed with another malignancy in last 5 years (except for cured basal cell carcinoma of skin or cervical carcinoma in situ).

4. Has been previously treated with doxorubicin or other anthracyclines and drugs forAML.

5. Allergic history of mitoxantrone hydrochloride injection or any other drugs used inthis study.

6. Those on systemic anti-infective therapy with poorly controlled infection (signs ofinfection progression within 1 week prior to the first dose, or as determined by theinvestigator).

7. Patient who is suffering from severe hemorrhagic diseases, such as haemophilia A,haemophilia B, von Willebrand disease and any other spontaneous bleeding requiremedical treatment.

8. The estimated survival time is less than 3 months.

9. Any of the following conditions occurs in cardiac function:(1) Long QTc syndrome orQTc interval > 480 ms;(2) Complete left bundle branch block or severeatrioventricular block disease (without a pacemaker);(3) Serious and uncontrolledarrhythmias and unstable angina pectoris requiring drug treatment;(4) History ofchronic congestive heart failure, New York Heart Association (NYHA)≥grade 3;(5) Thecardiac ejection fraction is less than 50% in Echocardiography;(6)Uncontrollablehypertension (defined as multiple measurements of systolic blood pressure > 150 mmHgor diastolic blood pressure > 90 mmHg under drug control);(7) History of myocardialinfarction, unstable angina pectoris, viral myocarditis or severe pericardialdisease, ECG evidence of acute ischemia or active conduction system abnormalitieswithin 6 months before first dose.

10. Patients have thromboembolic events within 6 months prior to first dose, such ascerebrovascular accidents (including transient ischemic attack) and pulmonaryembolism.

11. HBsAg/HBcAb positive with HBV-DNA higher than the lower limit of the detection valueof the research center , hepatitis C antibody-positive with HCV-RNA higher than thelower limit of the detection value of the research center, or HIV antibody positivein the preliminary screening.

12. Patients who have been treated with strong/moderate CYP3A inducers/inhibitors orP-gp inhibitors within 7 days prior to first dose (for treatment group 3 only).

13. Patients who cannot take oral medications or have absorption disorder (for treatmentgroup 3 only).

14. Patient is suffering from any serious and /or non-controllable disease, or theinvestigator determines that the disease might affect the participation of patientsin the study, including (but not limited to, uncontrolled diabetes, dialysis relatedkidney diseases, severe liver diseases, life-threatening autoimmune diseases andhemorrhagic diseases, drug abuse, neurological diseases, etc.).

15. Pregnant or lactating female.

16. Patients who are not suitable for this study as decided by the investigator due toother reasons.