Study With Temsirolimus Added to Standard Chemotherapy for Patients Over 60 Years With Acute Myeloblastic Leukemia

Exclusion Criteria

• •Previous treatment for AML, except leukapheresis for patients with hyperleukocytosis (leukocytes \> 100,000/µl and / or leukostatic syndrome) or hydroxyurea
• •Known central nervous system manifestation of AML
• •Cardiac Disease: Heart failure NYHA III° or IV°; active coronary artery disease (MI more than 6 months prior to study entry is permitted); serious cardiac ventricular arrhythmias, defined as: ventricular extrasystoles grade LOWN IV, sustained or non-sustained ventricular tachycardias, and history of ventricular fibrillation / ventricular flutter, unless patient is protected by an internal cardioverter / defibrillator or ventricular arrhythmia was attributable to a myocardial ischemia \> 6 months before study entry.
• •Chronically impaired renal function (creatinine clearance \< 30 ml / min)
• •Chronic pulmonary disease with relevant hypoxia
• •Inadequate liver function (ALT and AST ≥ 2.5 x ULN) if not caused by leukemic infiltration
• •Total bilirubin ≥ 1.2 mg/dL if not caused by leukemic infiltration
• •Uncontrolled active infection
• •Concurrent malignancies other than AML with an estimated life expectancy of less than two years and requiring therapy
• •Known HIV and/or hepatitis C infection
• •Evidence or history of CNS disease, including primary or metastatic brain tumors, seizure disorders
• •History of organ allograft
• •Concomitant treatment with kinase inhibitors, angiogenesis inhibitors, calcineurin inhibitors and Mylotarg
• •Serious, non-healing wound, ulcer or bone fracture
• •Allergy to study medication or excipients in study medication
• •Investigational drug therapy outside of this trial during or within 4 weeks of study entry
• •Any severe concomitant condition which makes it undesirable for the patient to participate in the study or which could jeopardise compliance with the protocol