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;

Exclusion Criteria:

• Diagnosis of acute promyelocytic leukemia (APL), French-American-British classification M3 or WHO classification of APL with translocation, t(15;17)(q22;q12); subjects who undergo diagnostic workup for APL and treatment with all-trans retinoic acid (ATRA), but who are found not to have APL, are eligible (treatment with ATRA must be discontinued before starting induction chemotherapy).

• Prior treatment for AML, except for the following allowances:

  1. Leukapheresis;
  2. Treatment for hyperleukocytosis with hydroxyurea;
  3. Growth factor/cytokine support;

• Uncontrolled or significant cardiovascular disease, including any of the following:

  1. Bradycardia of less than 50 beats per minute, unless the subject has a pacemaker;
  2. Diagnosis of or suspicion of long QT syndrome (including family history of long QT syndrome);
  3. Systolic blood pressure ≥180 mmHg or diastolic blood pressure ≥110 mmHg;
  4. History of clinically relevant ventricular arrhythmias (eg, ventricular tachycardia, ventricular fibrillation, or Torsade de Pointes);
  5. History of second (Mobitz II) or third degree heart block (subjects with pacemakers are eligible if they have no history of fainting or clinically relevant arrhythmias while using the pacemaker);
  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;