BI 811283 in Combination With Cytarabine in Previously Untreated AML Ineligible for Intensive Treatment

Inclusion criteria:

* Male or female adult with previously untreated acute myeloid leukaemia (AML)
* Confirmed diagnosis of AML according to the WHO definition (except for acute promyelocytic leukaemia, APL)
* Patient is considered ineligible for intensive treatment
* Patient is eligible for low-dose cytarabine (LD-Ara-C) treatment
* Life expectancy \> 3 months
* Eastern co-operative oncology group (ECOG, R01-0787) performance score \<=2 at screening
* Signed written informed consent consistent with international conference on harmonisation good clinical practice (ICH-GCP) and local legislation

Exclusion criteria:

* Patient with APL (AML subtype M3 according to the French-American-British (FAB) classification).
* Relapsed or treatment refractory AML.
* Hypersensitivity to one of the trial drugs or the excipients.
* Other malignancy requiring treatment.
* Known central nervous system involvement.
* Aspartate amino transferase (AST) or alanine amino transferase (ALT) greater than 2.5 times the upper limit of normal (ULN).
* INR \> 1.5 x ULN for subjects not on therapeutic vitamin K antagonists (phenprocoumon, warfarin).
* Bilirubin greater than 1.5 mg/dl.
* Serum creatinine greater than 2.0 mg/dl.
* LVEF (Left ventricular ejection fraction) \< 50% in echocardiography or clinical congestive heart failure New York Heart Association (NYHA) grade III or IV.
* Concomitant intercurrent illness, which would compromise the evaluation of efficacy or safety of the trial drug, e.g. active severe infection, unstable angina pectoris or cardiac arrhythmia.
* Psychiatric illness or social situation that would limit compliance with trial requirements.
* Concomitant therapy, which is considered relevant for the evaluation of the efficacy or safety of the trial drug (i.e. other chemo- or immunotherapy, see also section 4.2.2).
* Contraindications for cytarabine treatment according to the summary of product characteristics (SPC).
* Patients who are sexually active and unwilling to use a medically acceptable method of contraception during the trial (hormonal contraception, intrauterine device, condom with spermicide, etc.).
* Pregnant or nursing female patients.
* Patient unable to comply with the protocol.