- Phase I and II portion: Subjects of any age with untreated AML, if not candidates for standard induction chemotherapy or with poor risk AML (i.e. preceding MDS, myeloproliferative syndromes, leukemia due to cytotoxic chemotherapy for another condition, adverse cytogenetics or complex karyotype), or any subjects > 70 years of age with untreated AML. Acute promyelocytic leukemia (FAB M3) is excluded