Phase IIa Study Evaluating Safety and Efficacy of BL-8040 in Relapsed/Refractory AML Patients

Exclusion Criteria

• •1. Administration of conventional chemotherapy within 2 weeks of enrollment date. In the event that subjects have received chemotherapy \> 2 weeks from the date of enrollment, they may be included provided they have recovered from the associated non-hematological toxicities to ≤ grade 1.
• •2. Life expectancy of ≤ 2 months.
• •3. Known allergy or hypersensitivity to any of the test compounds, materials or contraindication to test product.
• •4. Use of investigational device or agents within 2 weeks of enrollment date.
• •5. Low Performance Status (ECOG \> 2; Appendix E).
• •6. O2 saturation \< 92% (on room air), evidence of Tumor Lysis Syndrome (TLS) \> grade 2 (according to the Cairo-Bishop criteria (3)) or leukostasis (2).
• •7. Abnormal liver function tests:
• •Serum aspartate transaminase (AST/SGOT) or alanine transaminase ( Alanine Transaminase (ALT)/Serum Glutamic Pyruvic Transaminase (SGPT)) 2 x upper limit of normal (ULN).
• •Serum bilirubin. Total bilirubin \> 2.0 mg/dL (34 µmol/L), conjugated bilirubin \> 0.8 mg/dL.
• •8. Left ventricular ejection fraction \< 40 %.
• •9. History of myocardial infarction or cerebrovascular accident within 6 months of enrollment date.
• •10. Presence of active, uncontrolled infection.
• •11. Known central nervous system disease (e.g., Alzheimer's disease).
• •12. Acute promyelocytic leukemia.
• •13. Exposure to high dose Ara-C within 6 months of enrollment.
• •14. Subject has concurrent, uncontrolled medical condition, laboratory abnormality, or psychiatric illness which could place him/her at unacceptable risk, including, but not limited to:
• •Subject has been diagnosed or treated for another malignancy within 3 years of enrolment, except in situ malignancy, or low-risk prostate, skin or cervix cancer after curative therapy A co-morbid condition which, in the view of the Investigators, renders the subject at high risk from treatment complications.
• •15. Female subjects who are pregnant or breastfeeding.
• •16. Prior clinically significant grade 3-4 non-hematological toxicity to high dose Ara-C or grade ≥ 2 of neurological toxicity.
• •17. Seropositive for HIV antibodies (HIV1 and HIV2), Hepatitis C antibody (Hep C Ab) or a Hepatitis B carrier (positive for Hepatitis B surface antigen \[HBsAg\]).
• •18. Unable to comply with study requirements in the opinion of the Investigator.