- Patients with AML or RAEB 2 High Risk MDS who are newly diagnosed according to the WHO
2008 Classification and previously untreated.
- Patients with AML (arising from an antecedent hematologic disease [AHD]) or MDS who
may have had one prior regimen with commercially available agents for the treatment of
their prior hematologic disease. The patients may not have had a prior therapy for
- AML patients include de novo AML, AML evolving from MDS or other AHD and AML after
previous cytotoxic therapy or radiation (secondary AML)
- For a diagnosis of AML, a bone marrow blast count of 20% or more is required.
- For a diagnosis of high-risk Myelodysplastic Syndrome RAEB 2 the patient must have
10-19% bone marrow blasts
- Adequate Organ Function
- ECOG Performance Status 0, 1, or 2
- AML M3 Acute Promyelocytic Leukemia (APL) or patients with a t(9:22) cytogenetic
- Patients with known active uncontrolled central nervous system (CNS) leukemia.