PF-05212384 (PKI-587) for t-AML/MDS or de Novo Relapsed or Refractory Acute Myeloid Leukemia (AML) (LAM-PIK)

Exclusion Criteria

• •1. Glucose intolerance or diabetes mellitus, treated or untreated
• •2. First cancer in evolution(solid tumor or lymphoma) or in remission for less than two years, except in situ carcinoma, basal cell carcinoma and squamous cell carcinoma
• •3. AML secondary to MDS or myeloproliferative syndrome (WHO 2008 definitions)
• •4. Acute Promyelocytic Leukaemia (APL or AML French American British (FAB) classification 3) de novo or secondary to treatment (t-APL)
• •5. de novo or secondary Core Binding Factor (CBF)/AML
• •6. de novo or secondary Philadelphia Chromosome (Ph) 1 positive AML defined by the presence of a t(9.22) or a Breakpoint Cluster Region-Abelson Murine Leukemia Viral Oncogene Homolog (BCR-ABL) transcript
• •7. Leukocytes above 30.000/mm3 (30 G/L) at enrollment
• •8. Antileukemic treatment within 15 days before enrollment, with the exception of hydroxyurea
• •9. Central nervous system leukemic involvement
• •10. Pregnant or lactating women, or women of childbearing potential without effective contraception
• •11. Prior history of allogeneic bone marrow transplantation
• •12. Prior history of organ transplantation or other cause of severe or chronic immunodeficiency Human
• •13. Seropositivity for Human Immunodeficiency Virus (HIV) or Human T-Lymphotropic Virus-1 (HTLV-1) viruses, active B or C hepatitis
• •14. Inclusion in another experimental anti-cancer clinical trial\*
• •15. Patients unable to undergo medical monitoring for geographical, social or psychological issues
• •16. Patient under measure of legal protection
• •17. No social security
• •* For ethical reasons, the exclusion period before considering the possibility of participating in another clinical study with a new experimental molecule cannot be determined, yet each case will be discussed on an individual basis with the study coordinator.