Inclusion Criteria

Inclusion criteria:

Male or female adult with relapsed/refractory AML ineligible for intensive treatment
(phase I part only) Male or female adult with previously untreated AML ineligible for
intensive treatment (phase IIa part only) Confirmed diagnosis of AML according to the WHO
definition (except for acute promyelocytic leukaemia, APL) Patient is eligible for
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:

Previously untreated AML (phase I part only) Relapsed or treatment refractory AML (phase
IIa part only) Patient with APL (AML subtype M3 according to the French-American-British
(FAB) classification) Hypersensitivity to one of the trial drugs or the excipients Other
malignancy requiring treatment Symptomatic central nervous system involvement Clinically
relevant QT prolongation (e.g. long QT syndrome, QTcF>470 ms) Aspartate amino transferase
(AST) or alanine amino transferase (ALT) greater than 2.5 times the upper limit of normal
(ULN), or AST or ALT greater than 5 times the ULN in case of known leukaemia liver
involvement Prothrombin time (PT) > 1.5 x ULN for subjects not on therapeutic vitamin K
antagonists (phenprocoumon, warfarin) Bilirubin greater than 1.5 mg/dl (> 26 mcmol/L)
Serum creatinine greater than 2.0 mg/dl Concomitant intercurrent illness, which would
compromise the evaluation of efficacy or safety of the trial drug, e.g. active severe
infection, unstable angina pectoris, cardiac arrhythmia or severe heart failure/cardiac
insufficiency.

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 Contraindications for cytarabine treatment according
to the SPC Female patients of childbearing potential who are sexually active and unwilling
to use a medically acceptable method of contraception during the trial, i.e. combination
of two forms of effective contraception (hormonal contraception, intrauterine device,
condom with spermicide, etc.).

Male patients with partners of childbearing potential who are unwilling to use condoms in
combination with a second medically acceptable method of contraception during the trial
Pregnant or nursing female patients Patient unable to comply with the protocol