Clinical Study Protocol of Venetoclax Combined With Azacitidine and Harringtonine in the Treatment of sAML

Inclusion Criteria:

• 1. Patients with acute myeloid leukemia (AML) newly diagnosed by bone marrowmorphology and immunophenotyping (in line with the WHO 2016 diagnostic criteria), andmeet any of the following conditions:
• Patients with treatment-related AML (tAML);
• AML patients with a previous history of MDS or CMML;
• AML patients with myelodysplasia-related cytogenetic abnormalities; 2) Age ≥ 18years old, and age < 80 years old; 3) Eastern Cooperative Oncology Group (ECOG)performance status score ≤2; 4) Aspartate aminotransferase (ALT), alanineaminotransferase (AST) and alkaline phosphatase (ALP) ≤ 3 × upper limit of normal (ULN), serum bilirubin ≤ 1.5 × ULN; serum creatinine ≤ 2.0 × ULN; Serummyocardial enzyme <2.0×ULN; 5) LVEF determined by echocardiography ≥50%; Obtaininformed consent signed by the patient or legal representative.

Exclusion Criteria:

• 1. AML with central nervous system (CNS) infiltration; 2) Acute promyelocytic leukemiaconfirmed by bone marrow morphology or immunophenotyping; 3) Have received Venetoclaxtreatment in the past; 4) Those who are known to be allergic to any drugs or otheringredients in the program; 5) Currently suffering from active autoimmune disease or ahistory of autoimmune disease potentially involving the CNS; 6) Known humanimmunodeficiency virus (HIV) infection; 7) Known history of active hepatitis B or C (HBV, HCV) infection; 8) Pregnant women and women who are trying to conceive; 9)Suffering from severe and/or uncontrolled mental illness; 10) Any life-threateningdisease, health condition, or organ system dysfunction that the investigator believesmay compromise the safety of the subject, or create an undue risk to the researchresults; 11) Received major surgery within 4 weeks before randomization; Participatein other clinical investigators at the same time one month before enrollment