Daunorubicin + Cytarabine + Venetoclax in de Novo AML

Prior treatment

• Prior treatment with venetoclax or azacitidine;
• History of angioplasty or stent placement within 12 months prior to signing the informed consent, or a history of myocardial infarction, unstable angina, or other clinically significant heart disease;
• Participation in any other clinical trial within 3 months prior to signing the informed consent;

Other illness

• Presence of other malignancies;
• Clinically uncontrolled active infection (including bacterial, fungal, or viral infections);
• Any other condition that, in the investigator's judgment, makes the patient unsuitable for participation in this study.

Other

• Pregnant or breastfeeding women;

• Patients with newly diagnosed AML based on FAB classification and flow cytometry standards who are eligible for intensive chemotherapy:
• Age between 18 and 59 years;
• Eastern Cooperative Oncology Group (ECOG) performance status score of 2 or 3;
• Expected survival time of ≥3 months;
• None of the following severe cardiac, pulmonary, hepatic, or renal conditions:
  • History of heart disease requiring treatment for congestive heart failure, or an ejection fraction ≤50%, or chronic stable angina;
  • Pulmonary diffusing capacity of carbon monoxide (DLCO) ≤65%, or forced expiratory volume in 1 second (FEV1) ≤65%;
  • Moderate liver impairment with total bilirubin \>1.5 to ≤3.0 × the upper limit of normal (ULN);
  • Creatinine clearance ≥30 mL/min to \<45 mL/min;
• Has not received radiotherapy, chemotherapy, targeted therapy, or hematopoietic stem cell transplantation within 4 weeks prior to enrollment;
• Has other comorbidities that, in the physician's judgment, make intensive chemotherapy unsuitable;
• Is capable of understanding and willing to sign the informed consent form for this study.