Azacitidine Combined With Venetoclax and ATRA in Newly Diagnosed AML

A Single Arm Study to Evaluate the Safety and Efficiency of Azacitidine (AZA) Combination With Venetoclax and ATRA in Patients With Newly Diagnosed Acute Myeloid Leukemia

This is a single arm study to evaluate the safety and efficiency of azacitidine (AZA) combination with venetoclax and ATRA in Patients With Newly diagnosed acute myeloid leukemia. Azacitidine, venetoclax and ATRA, may stop the growth of cancer cells, either by demethylation, by promoting cells differentiation or by killing the cells.

This study include newly diagnosed AML patients who will accept the therapy with AZA combined with venetoclax and ATRA: (1)Inductive therapy: AZA 75mg/m² per day for days 1-7 and venetoclax 100mg orally for day 2 , 200mg orally for day 3, 300mg orally for day4-6, 400mg orally for day7-10,ATRA 45mg/m² for day 12-28, every 28 days for up to 2 cycles or progression; (2)Consolidate therapy:ATRA 45mg/m2 per day for d1-21 ,AZA 70mg/m² per day for days 1-7, every 28 days for up to 4 cycles or progression; (3) Maintenance therapy:ATRA 45mg/m2 for d1-21 every 28 days,AZA 70mg/m² per day for days 1-7, every 3 month till progression;

Inclusion Criteria:

• Newly diagnosed AML according to the WHO (2016) classification of acute myeloid leukemia.
• Age ≥ 18years.
• ECOG score: 0-3.
• White blood cell count ≤ 25*10^9/L
• Total bilirubin ≤ 3X the institutional upper limit of normal if attributable to hepatic infiltration by neoplastic disease
• AST (SGOT) and ALT (SGPT) ≤ 3X the institutional upper limit of normal
• Creatinine clearance ≥30ml/min

Exclusion Criteria:

• Pregnancy or lactation.
• Acute promylocytic leukemia or chronic myeloid leukemia in blast crisis.
• Another malignant disease.
• Uncontrolled active infection.
• Left ventricular ejection fraction < 0.3 by echocardiography or grade III/IV cardiovascular dysfunction according to the New York Heart Association Classification.
• Active hepatitis B or hepatitis C infection.
• HIV infection.
• Other commodities that the investigators considered not suitable for the enrollment.