Study With Temsirolimus Added to Standard Chemotherapy for Patients Over 60 Years With Acute Myeloblastic Leukemia (TOR-AML)

This is an interventional treatment trial for Acute Myeloblastic Leukemia Read More

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