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

Inclusion Criteria:

1. AML confirmed by bone marrow cytology and pathology;
2. Meet the diagnostic criteria for relapsed and refractory AML. Diagnostic criteria forrelapsed AML: leukemia cells reappeared in peripheral blood after complete remissionor blast cells in bone marrow >0.05 (except for other reasons such as bone marrowregeneration after consolidation chemotherapy) or extramedullary leukemia cellinfiltration. Diagnostic criteria for refractory AML: naive patients who wereineffective after 2 courses of standard regimens; patients who relapsed within 12months after consolidation and intensive therapy after CR; patients who relapsed after 12 months but were ineffective after conventional chemotherapy; 2 or more Secondaryrelapse; persistent extramedullary leukemia;
3. Eastern Cooperative Oncology Group (ECOG) performance status of 0 to 2;
4. Liver and kidney function: Alanine aminotransferase (AST) and aspartateaminotransferase (ALT) ≤2.5 x upper limit of normal (ULN) (≤5 x ULN for patients withliver infiltrates); Total bilirubin ≤1.5 x ULN (≤3 x ULN for patients with liverinfiltration); Serum creatinine ≤1.5 x ULN;
5. Normal cardiac function: left ventricular ejection fraction (LVEF) ≥ 45% assessed byechocardiography or radionuclide active angiography (MUGA);
6. Pulmonary function: dyspnea ≤ CTC AE grade 1 and SaO2 ≥ 92% in indoor air environment;
7. The expected survival time is greater than 3 months;
8. Patients voluntarily participated in this study and signed the informed consent.

Exclusion Criteria:

1. The subject had previously received any of the following anti-tumor treatments:a)Those who have previously received mitoxantrone or mitoxantrone liposome;b)Previously received doxorubicin or other anthracycline treatment, and the totalcumulative dose of doxorubicin is more than 360 mg/m^2 (1 mg doxorubicin convertedfrom other anthracycline drugs is equivalent to 2 mg daunorubicin or 0.5 mgidarubicin); c)Have received anti-tumor treatment (including chemotherapy, targetedtherapy, hormone therapy, taking traditional Chinese medicine with anti-tumoractivity, etc.) or participated in other clinical trials and received clinical trialdrugs within 4 weeks before the first use of the study drugs;
2. Heart function and disease meet one of the following conditions: a)Long QTc syndromeor QTc interval > 480 ms; b)Complete left bundle branch block, grade II or IIIatrioventricular block; c)Serious and uncontrolled arrhythmias requiring drugtreatment; d)New York Heart Association grade ≥ II; e)A history of myocardialinfarction, unstable angina pectoris, severe unstable ventricular arrhythmia or anyother arrhythmia requiring treatment, a history of clinically serious pericardialdisease, or ECG evidence of acute ischemia or active conduction system abnormalitieswithin 6 months before recruitment.
3. Identify patients with central nervous system invasion;
4. Other malignancies, except for effectively controlled non melanoma skin basal cellcarcinoma, breast / cervical carcinoma in situ, and other malignancies that have beeneffectively controlled without treatment in the past five years;
5. Non controlled systemic diseases (such as active infection, non controlledhypertension, diabetes, etc.);
6. Human immunodeficiency virus (HIV) infection (HIV antibody positive);
7. Active hepatitis B and C infection (hepatitis B test: if there is a positive hepatitisB surface antigen or core antibody, add HBV DNA, and the hepatitis B virus DNA exceeds 1x10^3 copies/mL to exclude; hepatitis C: if the hepatitis C antibody is positive,further test HCV RNA, hepatitis C Viral RNA exceeding 1x10^3 copies/mL was excluded);
8. Hypersensitivity to any study drug or its components;
9. Pregnant women, lactating women, patients who refused to take effective contraceptivemeasures during the study;
10. Serious neurological or psychiatric history;
11. Unsuitable subjects for this study determined by the investigator.