A Study of Volasertib Plus Induction Chemotherapy for Acute Myeloid Leukemia

Exclusion Criteria

• •1. Prior anthracycline exposure equivalent to \> 300 mg/m2 doxorubicin.
• •2. Prior chemotherapy or radiotherapy within previous four weeks except for hydroxyurea.
• •3. Prior treatment with volasertib or any other Polo-like kinase inhibitor
• •4. Known hypersensitivity to the trial drug
• •5. Serum creatinine \> 1.5 times (1.5x) upper limit of normal (ULN) or creatinine clearance (CLcr) \< 30 ml/min (estimated creatinine clearance by the Cockcroft-Gault (C-G) equation
• •6. Serum bilirubin \> 1.5x ULN, or aspartate aminotransferase (AST) or alanine aminotransferase (ALT) \> 3x ULN
• •7. Persistence of clinically relevant therapy related toxicity from previous anti-cancer therapy
• •8. Active central nervous system leukemia (no lumbar puncture required; clinical judgement is sufficient)
• •9. Treatment with other investigational drugs or treatment in another clinical trial within the past 4 weeks before start of therapy or concomitantly with the trial
• •10. Significant cardiovascular diseases (i.e. uncontrolled hypertension, unstable angina, history of infarction within the past 12 months prior to start of study treatment, congestive heart failure (\> New York Heart Association-II), serious cardiac arrhythmia, pericardial effusion)
• •11. QTcF prolongation \> 470 ms or QT prolongation deemed clinically relevant by the investigator (e.g., congenital long QT syndrome).The QTcF will be calculated as the mean of the 3 ECGs taken at screening.
• •12. Other concurrent malignancy requiring active therapy (except hormonal therapy for prostate or breast cancer).
• •13. Severe uncontrolled infection. Controlled infection on antibiotics is permitted.
• •14. Active or chronic hepatitis C and/or B infection
• •15. Known HIV infection
• •16. Serious illness or concomitant non-oncological disease such as neurologic, psychiatric, infectious disease or active ulcers (gastro-intestinal tract, skin) or laboratory abnormality that may increase the risk associated with study participation or study drug administration and in the judgment of the investigator would make the patient inappropriate for entry into the study.
• •17. Patients who are sexually active and unwilling to use a medically acceptable method of contraception (e.g. such as implants, injectables, combined oral contraceptives, some intrauterine devices or vasectomized partner for participating females, condoms for participating males) during the trial and for at least six months after end of active therapy on study.
• •18. Pregnancy or breast feeding, female patients must have a negative pregnancy test prior to commencing study treatment.
• •19. Psychological, familial or sociological factors potentially hampering compliance with the study protocol and follow-up schedule
• •20. Known or suspected active alcohol or drug abuse