IA14 Induction in Young Acute Myeloid Leukemia

Inclusion Criteria

• •Newly diagnosed, morphologically documented primary AML or AML secondary to myelodysplastic syndrome or a myeloproliferative neoplasm based on the World Health Organization (WHO) 2008 classification (at Screening)
• •Must be competent and able to comprehend, sign, and date an Ethics Committee or Institutional Review Board approved Informed Consent Form (ICF) before performance of any study-specific procedures or tests;
• •≥18 yearsand ≤60 years (at Screening);
• •Eastern Cooperative Oncology Group performance status 0-2 (at Screening);
• •Adequate renal function defined as: Creatinine clearance rate \>50 mL/min, as calculated with the modified Cockcroft Gault equation;
• •Adequate hepatic function defined as: Total serum bilirubin ≤1.5 × ULN; and serum alkaline phosphatase, aspartate transaminase and alanine transaminase ≤2.5 × ULN;
• •Serum electrolytes within normal limits: potassium, calcium (total or corrected for serum albumin in case of hypoalbuminemia). If outside of normal limits, subject will be eligible when electrolytes are corrected;
• •6. History of uncontrolled angina pectoris or myocardial infarction within 6 months prior to Screening;
• •7. History of New York Heart Association Class 3 or 4 heart failure;
• •8. Complete left bundle branch block;
• •9. Known history of left ventricular ejection fraction (LVEF) ≤45% or less than the institutional lower limit of normal;
• •Active acute or chronic systemic fungal, bacterial, or viral infection not well controlled by antifungal, antibacterial or antiviral therapy;
• •Concurrent of other malignancies, except adequately treated non-melanoma skin cancer, curatively treated in-situ disease, or other solid tumors curatively treated with no evidence of disease
• •Females who are pregnant or breastfeeding;