Safety and Efficacy of Venetoclax Combination With Decitabine(DEC3-VEN) in the Treatment of AML in the Adult

Inclusion Criteria:

Subjects suitable for enrollment in this study must meet all of the following criteria:

1. meet the World Health Organization diagnostic criteria (WHO2022 criteria) other than APL or carrying one of the abnormal karyotypes such as t(8;21)/(RUNX1::RUNX1TI), inv(16)(p13.1q22), t(16;16) (p13.1q22), t(16;16)/CBFβ::myh11), etc. Patients with acute myeloid leukemia other than those with one of the abnormal karyotypes such as t(16;16)/CBFβ::myh11
2. Patients with AML not otherwise classified under the World Health Organization AML classification, except for acute myeloproliferative disorder with myelofibrosis and myeloid sarcoma;
3. patients of either sex, age greater than or equal to 16 years and less than 65 years, with a primary diagnosis of AML, who are considered suitable for intensive chemotherapy;
4. Eastern Cooperative Oncology Group (ECOG) physical status ≤ 2 at enrollment;
5. the patient has not received prior treatment for AML (except hydroxyurea and Ara-C <1.0 g/d for tumor composite reduction);
6. passes the following laboratory test markers (performed within 7 days prior to treatment):1) aspartate aminotransferase (ALT), alanine aminotransferase (AST), and alkaline phosphatase (ALP) ≤ 3 x upper limit of normal (ULN), serum bilirubin ≤ 2 x ULN; and serum cardiac enzymes < 2.0 x ULN; unless leukemic organ involvement is considered.2) Creatinine ≥ 30 mL/min, calculated by the Cockcroft Gault formula or measured by 24-hour urine collection
7. Female subjects of childbearing potential must have a negative pregnancy test result within 72 hours prior to the start of treatment; no pregnancy is planned during the study and within 6 months of the last dose of study drug, and a negative urine or serum pregnancy test result at screening. Men must use latex condoms during any sexual contact with WOCBP, even if they have undergone a successful vasectomy, and must agree to avoid childbearing (during treatment and within 6 months of the last dose of study drug);
8. have a life expectancy of more than 2 months;
9. informed consent must be signed prior to the start of all specific study procedures, either by the patient himself/herself or by a member of his/her immediate family; if, in view of the patient's medical condition, his/her own signature would not be conducive to the treatment of his/her medical condition, the informed consent will be signed by his/her legal guardian or by a member of the patient's immediate family.

Exclusion Criteria:

Subjects may not be enrolled in this study if they meet any of the following criteria:

1. AML with BCR-ABL1; or CML acute stage;
2. Treatment-naïve patients (is defined as having received prior induction chemotherapy regardless of efficacy);
3. Subjects with acute total myelopathy with myelofibrosis or myeloid sarcoma as defined by WHO 2016;
4. Secondary leukemia (primarily those whose World Health Organization (WHO 2016) AML classification falls into the subcategory of treatment-related AML and those with a history of prior MDS and/or MPD);
5. concurrent other hematologic diseases (e.g., hemophilia, myelofibrosis, etc., who are considered unsuitable for enrollment by the investigator; those who have previous blood abnormalities but have ever had bone marrow tests except for MDS and MPD are allowed to be enrolled);
6. Pregnant or lactating patients;
7. Those who are allergic to any drugs involved in this study;
8. Have used strong or moderate CYP7A inducers within 3 days prior to the start of study treatment;
9. concurrent malignant tumors of other organs (those requiring treatment);
10. Significantly abnormal hepatic or renal function beyond the enrollment criteria;
11. Active heart disease, defined as one or more of the following:1) Myocardial infarction less than 6 months from study entry; 2) A history of arrhythmia requiring medication or severe clinical symptoms; 3) Uncontrolled or symptomatic congestive heart failure (> NYHA class 2); 4) Uncontrolled or symptomatic angina;5) Left ventricular ejection fraction below the lower limit of the normal range;
12. severe infectious diseases (untreated tuberculosis, pulmonary aspergillosis), patients with known infection with human immunodeficiency virus (HIV) or active hepatitis B or C; subjects with uncontrolled treatment.
13. Subjects with evidence of central nervous system leukemia prior to treatment;
14. Subjects with epilepsy requiring medication, dementia, or other abnormal mental states that are unable to understand or follow the regimen;
15. Conditions that limit oral drug intake or gastrointestinal absorption;
16. those who, in the opinion of the investigator, are not suitable for enrollment;