Chidamide, Venetoclax, and Azacitidine for Newly Diagnosed Acute Myeloid Leukemia

Inclusion Criteria:

• （1）Age ≥18 years old, no gender limit ;

• （2）be diagnosed with AML (non-M3) according to WHO 2016 standards;

• （3）No previous treatment;

• （4）Ineligible for intensive chemotherapy based on the following definitions: ≥75years of age or 18 to 74 years of age with at least one of the followingcomorbidities: Eastern Cooperative Oncology Group (ECOG) performance status of 2 or 3 A history of cardiac disease such as congestive heart failure Treatment isrequired, or ejection fraction ≤ 50%, or chronic stable angina, diffusing capacityof lung for carbon monoxide (DLCO) ≤ 65%, or forced expiratory volume in firstsecond (FEV1) ≤ 65%, creatinine clearance ≥ 30 mL/min to < 45 mL/min, moderatehepatic impairment, total bilirubin > 1.5 to ≤ 3.0 × ULN, other comorbidities thatare not suitable for intensive chemotherapy in the physician's judgment.

• （5）Subjects must have an ECOG performance status score of: 0 to 2 for subjects aged ≥ 75 years or 0 to 3 for subjects aged ≥ 18 to 74 years.

• （6）Other comorbidities that are not suitable for intensive chemotherapy in thedoctor's judgment;

• （7）Expected survival time ≥3 months;

• （8）Have the ability to understand and be willing to sign the informed consent formfor this study.

Exclusion Criteria:

• (1) Combined with other malignant tumors

• (2) Have ever received treatment with chidamide and / or venetoclax or azacitidine;

• (3) The risk is assessed as low risk according to the NCCN 2022 guidelines [t(8;21)(q22;q22.1);RUNX1-RUNX1T1, inv(16)(p13.1q22) or t(16;16 )(p13.1;q22);CBFB-MYH11 ] ;

• (4) The subject is known to have AML central nervous system (CNS) infiltration;

• (5) Have undergone cardiac angioplasty or stent placement within 12 months beforesigning the informed consent form , or have a history of myocardial infarction,unstable angina, or other clinically significant heart disease;

• (6 ) Active infections (including bacterial, fungal or viral infections) and organbleeding that cannot be controlled clinically;

• (7) Pregnant or lactating women;

• (8) Participated in any other clinical research within 3 months before signing theinformed consent form ;

• (9 ) The researcher believes that it is not suitable to participate in this study;