Study of Vosaroxin With Azacitidine in Patients With Newly Diagnosed Acute Myeloid Leukemia or Myelodysplastic Syndrome With Excess Blasts-2

Exclusion Criteria

• •1. Known or suspected hypersensitivity to the study drugs and/or any excipients
• •2. Favorable genetics: t(15;17)(q22;q12), PML-RARA; t(8;21)(q22;q22), RUNX1-RUNX1T1; inv(16)(p13.1q22)/t(16;16)(p13.1;q22), CBFB-MYH11; mutated NPM1 without FLT3-ITD or with FLT3-ITDlow
• •3. Prior treatment for AML except hydroxyurea
• •4. Prior treatment for MDS with hypomethylating agents
• •5. ECOG performance status \>2
• •7. Inadequate cardiac, hepatic and/or renal function at the Screening Visit defined as:
• •* Ejection fraction \<40% confirmed by echocardiography
• •* Creatinine \>1.5x upper normal serum level
• •* Total bilirubin, AST or ALT \>1.5 upper normal serum level
• •8. Active central nervous system involvement
• •9. Any clinically significant, advanced or unstable disease or history of that may interfere with primary or secondary variable evaluations or put the patient at special risk, such as:
• •* Myocardial infarction, unstable angina within 3 months before screening
• •* Heart failure NYHA III/IV
• •* Severe obstructive or restrictive ventilation disorder
• •* Uncontrolled infection
• •10. Severe neurological or psychiatric disorder interfering with ability of giving an informed consent
• •11. Currently receiving a therapy not permitted during the study, as defined in Section 10.5.4
• •12. Patients with a "currently active" second malignancy other than non-melanoma skin cancers. Patients are not considered to have a "currently active" malignancy if they have completed therapy and are considered by their physician to be at less than 30% risk of relapse within one year.
• •13. Known history of positive test for Hepatitis B surface Antigen (HBsAg) or hepatitis C antibody or history of positive test for Human Immunodeficiency Virus (HIV)
• •14. Hematological disorder independent of leukemia
• •15. No consent for registration, storage and processing of the individual disease characteristics and course as well as information of the family physician and/or other physicians involved in the treatment of the patient about study participation
• •16. No consent for biobanking
• •17. Current participation in any other interventional clinical study within 30 days before the first administration of the investigational product or at any time during the study
• •18. Patients known or suspected of not being able to comply with this trial protocol
• •19. Patients of childbearing potential not willing to use adequate contraception during study and 3 months after last dose of therapy
• •20. Breast feeding women or women with a positive pregnancy test at Screening visit