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

Inclusion Criteria:

* Newly diagnosed AML (except APL) according to the FAB classification, including AML evolving from MDS or other hematological diseases and AML after previous cytotoxic therapy or radiation (secondary AML)
* Bone marrow aspirate or biopsy contains ≥ 20% blasts of all nucleated cells or differential blood count must contain ≥ 20% blasts. In AML FAB M6 ≥ 30% of non-erythroid cells in the bone marrow must be leukemic blasts. In AML defined by cytogenetic aberrations the proportion of blasts may be \< 20%.
* Age ≥ 61 years
* Informed consent, personally signed and dated to participate in the study
* Willingness of male patients whose sexual partners are women of child-bearing potential (WOCBP), to use an effective form of contraception (pearl index \< 1%) during the study and at least 6 months thereafter.

Exclusion Criteria:

* Patients who are not eligible for standard chemotherapy
* 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