Study of VA Combined With HAAG Regimen in Newly Diagnosed Intermediate and High-risk AML Patients

This is a single-center, single-arm, prospective clinical study in newly diagnosed intermediate and high-risk AML patients. The patients will receive venetoclax, azacitidine combined with HAAG regimen in the induction treatment.

Inclusion criteria

• Newly diagnosed intermediate and high-risk AML according to the WHO (2022) classification of acute myeloid leukemia (non-APL).
• Age 18-65.
• ECOG score: 0-2.
• No history of previous chemotherapy or target therapy.
• Serum total bilirubin <= 2 times the upper limit of normal (ULN), alanine aminotransferase (ALT) <= 1.5 times ULN, aspartate aminotransferase (AST) <=1.5 times ULN;
• Creatinine clearance rate >=30 mL/min;
• Serum lipase <= 1.5 times ULN, amylase <= 1.5 times ULN;
• Capable to understand and willing to participate in this study, signed the informed consent form.

Exclusion criteria

• AML transformed with chronic myelogenous leukemia.
• Acute promyelocytic leukemia (type M3).
• Patients with a second malignancy requiring treatment.
• Patients with uncontrolled active infection.
• Patients with left ventricular ejection fraction < 0.5 by echocardiography or grade III/IV cardiovascular dysfunction according to the New York Heart Association Classification.
• Patients with hepatic and renal inadequacy: total serum bilirubin >=2.0 mg/dl, AST >=3 times ULN, serum creatinine clearance (Ccr) <50 ml / min.
• Patients with arterial oxygen saturation (SpO 2) was <95%.
• Patients with HIV infection.
• Patients with active hepatitis B or hepatitis C infection.
• Patients with other commodities that the investigators considered not suitable for the enrollment.