Inclusion Criteria

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.