Comparison Between Two Dose Levels of Daunorubicin and Between One vs. Two Induction Cycles for Adult Patients With AML

Inclusion Criteria:

* Newly diagnosed AML other than acute promyelocytic leukemia (APL) according to WHO criteria, i.e. bone marrow aspirate or biopsy must contain ≥20% blasts of all nucleated cells or differential blood count must contain ≥20% blasts. In acute erythroid leukemia, ≥20% blasts in all non-erythroid bone marrow cells. In AML defined by cytogenetic aberrations, the rate of blasts may be \<20%. Secondary AMLs are eligible for inclusion.
* Age 18- inkl.65 years
* Eastern Cooperative Oncology Group (ECOG) performance status 0-2
* Adequate liver and renal function as assessed by the following laboratory requirements to be conducted within 7 days prior to screening:

  * Total bilirubin ≤ 1.5 times the upper limit of normal
  * alanine transaminase (ALT) and aspartate transaminase (AST) ≤ 2.5 times upper limit of normal
  * Creatinine ≤ 1.5 times upper limit of normalExclusion Criteria:
* Adequate cardiac function, i.e. left ventricular ejection fraction (LVEF) of ≥ 50% as assessed by transthoracic two-dimensional echocardiography ("M Mode") or multiple gated acquisition scan (MUGA scan)
* Signed informed consent
* Women must fulfill at least one of the following criteria in order to be eligible for trial inclusion:

  * Post-menopausal (12 months of natural amenorrhea or 6 months of amenorrhea with Serum follicle stimulating hormone (FSH) \> 40 U/ml)
  * Postoperative (i.e. 6 weeks) after bilateral ovariectomy with or without hysterectomy
  * Continuous and correct application of a contraception method with a Pearl Index of \<1% (e.g. implants, depots, oral contraceptives, intrauterine device - IUD).
  * Sexual abstinence
  * Vasectomy of the sexual partner

Exclusion criteria:

* Patients who are not eligible for standard chemotherapy as assessed by the treating physician
* Central nervous system manifestation of AML
* Cardiac disease: i.e. heart failure New York Heart Association (NYHA) III or IV; unstable coronary artery disease (MI more than 6 months prior to study entry is permitted); serious cardiac ventricular arrhythmias requiring anti-arrhythmic therapy
* Patients undergoing renal dialysis
* Chronic pulmonary disease with clinical relevant hypoxia
* Known HIV or Hepatitis infection
* Uncontrolled active infection
* Medical conditions other than AML with an estimated life expectancy below 6 months
* Previous treatment of AML except hydroxyurea up to 5 days
* Relapsed or primary refractory AML
* Acute promyelocytic leukemia
* Previous anthracycline-containing chemotherapy
* Treatment with any known non-marketed drug substance or experimental therapy within 4 weeks prior to enrollment
* Incapability of understanding purpose and possible consequences of the trial
* Pregnant or breastfeeding women
* Evidence suggesting that the patient is not likely to follow the study protocol (e.g. lacking compliance)