Phase III Study of Induction and Consolidation Chemotherapy With Venetoclax in Patients With Newly Diagnosed AML or MDS-EB-2

Inclusion Criteria

• •1. Patients with newly diagnosed acute myeloid leukemia (AML) according to the International Consensus Classification (ICC).
• •2. Age ≥ 18 and ≤ 75 years.
• •3. Patients considered eligible for intensive chemotherapy.
• •4. Eastern Cooperative Oncology Group (ECOG) performance status ≤ 2.
• •5. Molecular analysis centrally performed in AMLSG and HOVON laboratories.
• •6. Adequate renal function as evidenced by serum creatinine ≤ 2.0 × upper limit of norm (ULN) or creatinine clearance \>40 mL/min based on the Cockcroft-Gault glomerular filtration rate (GFR).
• •7. Adequate hepatic function as evidenced by:
• •* Serum total bilirubin ≤ 2.5 × ULN unless considered due to Gilbert's disease, or leukemic involvement following approval by the Principal Investigators or Trial Coordinators of the study
• •* Aspartate aminotransferase (AST), alanine aminotransferase (ALT), and alkaline phosphatase (ALP) ≤ 3.0 × ULN, unless considered due to leukemic involvement following approval by the Principal Investigators or Trial Coordinators.
• •8. No prior chemotherapy for AML, except hydroxyurea for up to 14 days during the diagnostic screening phase for the control of peripheral leukemic blasts in patients with leukocytosis (e.g., white blood cell \[WBC\] counts \> 25x109/L); patients may have had previous treatment with erythroid stimulating agents (ESA) or hypomethylating agents (HMAs) for an antecedent phase of MDS; ESA and HMAs have to be stopped at least four weeks before start of study treatment.
• +22 more criteria