Patients with newly diagnosed AML (except APL) according to the FAB and WHO classification, including AML evolving from MDS or other hematologic diseases and AML after previous cytotoxic therapy or radiation (secondary AML)

Nein

Bone marrow aspirate or biopsy must contain >= 20% blasts of all nucleated cells, with the exception of AML FAB M6, where >= 30% of non-erythroid cells must be leukemic blasts

Nein

Age >= 61 years

Nein

Informed consent, personally signed and dated to participate in the study

Nein

Male patients enrolled in this trial must use adequate barrier birth control measures during the course of the Sorafenib treatment and for at least 3 months after the last administration of Sorafenib

Nein

Ausschlusskriterien

Central nervous system manifestation of AML

Nein

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 requiring anti-arrhythmic therapy (beta blockers or digoxin are permitted)

Nein

Chronically impaired renal function (creatinin clearance < 30 ml/min)

Nein

Chronic pulmonary disease with relevant hypoxia

Nein

Inadequate liver function (ALT and AST >= 2.5 x ULN)

Nein

Total bilirubin >= 1.5 x ULN

Nein

Resting blood pressure (BP) consistently higher than systolic 160 mmHg and/or diastolic 95 mmHg

Nein

Any severe concomitant condition which makes it undesirable for the patient to participate in the study or which could jeopardise compliance with the protocol

Nein

Uncontrolled active infection

Nein

Concurrent malignancies other than AML

Nein

Previous treatment of AML except hydroxyurea and up to 2 days <= 100 mg/m2/d cytarabine

Nein

Known HIV and/or hepatitis C infection

Nein

Evidence or history of CNS disease, including primary or metastatic brain tumors, seizure disorders

Nein

Thrombotic or embolic events such as cerebrovascular accident or pulmonary embolism within 1 year of study entry

Nein

Evidence or history of severe non-leukemia associated bleeding diathesis or coagulopathy

Nein

History of organ allograft

Nein

Concomitant treatment with kinase inhibitors, angiogenesis inhibitors and Myelotarg

Nein

Patients with major surgery, open biopsy or significant traumatic injury within 4 weeks of start or first dose

Nein

Serious, non-healing wound, ulcer or bone fracture

Nein

Allergy to study medication or excipients in study medication

Nein

Investigational drug therapy outside of this trial during or within 4 weeks of study entry

Nein

Patients who are not eligible for standard chemotherapy

Nein

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Eligibility NCT00373373 Acute Myeloid Leukemia

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