Clinical Study Protocol of Idarubicin, Cytarabine, and Venetoclax -Induced Remission Followed by Consolidation Therapy With Medium-dose Cytarabine Combined With Venetoclax in Newly Diagnosed Adult Acute Myeloid Leukemia
This study evaluates the efficacy and safety of the combination of idarubicin and cytarabine induction followed by intermediate-dose cytarabine consolidation with venetoclax in the treatment of newly diagnosed adult acute myeloid leukemia (AML). This study includes the induction and consolidation phases of AML treatment.
• Newly diagnosed primary AML patients. Diagnostic criteria refer to the 2022 WHO classification.
• Age between 18 and 60 years old.
• Eastern Cooperative Oncology Group (ECOG) performance status of 0-2 (see Appendix 2).
• Cardiac ultrasound LVEF ≥ 45%.
• Creatinine clearance ≥ 50 mL/min (calculated using the Cockcroft-Gault formula or measured using a 24-hour urine sample).
• Liver function: Aspartate aminotransferase (AST) ≤ 2.5 × ULN\*; Alanine aminotransferase (ALT) ≤ 2.5 × ULN\*; Total bilirubin ≤ 1.5 × ULN\* (\*unless considered due to leukemia infiltration).
• Signed informed consent form.