Volasertib + Decitabine in Patients With Acute Myeloid Leukemia (AML)

Inclusion criteria:

1. Dose Escalation Phase: patients with previously untreated AML, relapsed or refractory
AML regardless of prior treatment status.

2. MTD Extension Phase: previously untreated AML (prior treatment for Myelodysplastic
Syndrome(MDS) is allowed).

3. Age >= 65 years.

4. Previously untreated patients must be ineligible for receiving standard intensive
therapy at the time of enrolment, in the opinion of the investigator and based on
documented medical reasons.

5. Histologically or cytologically confirmed AML (except for APL, FAB
(French-American-British)subtype M3) according to the World Health Organisation
classification.

6. Eastern co-operative oncology group (ECOG) performance score =< 1 at screening.

7. Signed and dated written informed consent by start date of Screening Visit in
accordance with Good Clinical Practice and local legislation.

Exclusion criteria:

1. MTD Extension Phase: Prior chemotherapy for AML (except for hydroxyurea). Patients can
receive treatment with hydroxyurea in order to reduce high White Blood Cells count for
no more than 28 days (cumulative); discontinuation of hydroxyurea at least one day
prior to the study treatment is required. Please note that any prior therapy for MDS
is allowed.

2. Acute promyelocytic leukemia (APL, FAB subtype M3), according to World Health
Organisation classification.

3. Hypersensitivity to the trial drugs.

4. Other malignancy currently requiring active therapy (except for hormonal/anti-hormonal
treatment, e.g. in prostate or breast cancer).

5. Known clinical central nervous system (CNS) symptoms deemed by the investigator to be
related to leukemic CNS involvement.

6. QTcF (QT interval corrected for heart rate by the Fridericia formula) > 470 ms,
calculated as the mean value of the triplicates taken at least 2 minutes apart at
baseline or QTcF prolongation deemed clinically relevant by the investigator.

7. Baseline Left Ventricular Ejection Fraction of < 45% or below the lower limit of
institutional normal range.

8. Aspartate amino transferase (AST) or alanine amino transferase (ALT) > 2.5 x the upper
limit of normal (ULN). Patients with elevated liver enzyme(s) due to leukemic
involvement are allowed up to = 5 x the ULN.

9. Total bilirubin > 1.5 x ULN. For patients with Gilbert's syndrome or elevation due to
hepatic infiltrate, total bilirubin must be <4 x ULN.

10. Creatinine clearance (CLcr) < 30 ml/min (estimated creatinine clearance by the
Cockcroft-Gault (C-G) equation.

11. Severe illness or organ dysfunction involving the kidneys, liver or other organ
system, including active uncontrolled infection, which in the opinion of the
investigator precludes treatment with decitabine or would interfere with the
evaluation of the safety of the study treatment.

12. Presence of clinically relevant cardiovascular abnormalities such as uncontrolled
hypertension, congestive heart failure New York Heart Association (NYHA)
Classification of 3, unstable angina or poorly controlled arrhythmia as determined by
the investigator. Myocardial infarction within 6 months prior to study entry.

13. Significant concurrent psychiatric disorder or social situation that according to the
investigator's judgment would compromise patient's safety or compliance, interfere
with consent, study participation, or interpretation of study results.

14. Patients with a systemic fungal, bacterial, viral, or other infection that is not
controlled.

15. Contraindications for decitabine treatment according to the manufacturer's prescribing
information provided in the Investigator Site File

16. Female patients of childbearing potential who are sexually active and unwilling to use
a medically acceptable method of contraception during the trial and for a minimum of 6
months after completion of study treatment.

17. 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 and for a minimum of 6 months after completion of study treatment.

18. Pregnant or breast feeding patients.

19. Treatment with any investigational drug within 2 weeks of administration of first
study medication dose or within less than five half -lives of the investigational drug
before treatment with the present trial drug, whichever is shorter, and / or
persistence of toxicities of prior anti-leukemic therapies which are deemed clinically
relevant.

20. Prior treatment with a Plk inhibitor such as volasertib or treatment in a clinical
trial using a Plk inhibitory compound.