Study of Vidaza Versus Conventional Care Regimens for the Treatment of Acute Myeloid Leukemia (AML)

Inclusion Criteria:

- Diagnosis of one of the following

- Newly diagnosed de novo acute myeloid leukemia (AML)

- AML secondary to myelodysplastic syndromes (MDS)

- AML secondary to exposure to leukemogenic therapy or agents with primary
malignancy in remission for at least 2 years

- Bone marrow blasts >30%

- Age ≥ 65 years

- Easter Cooperative Oncology Group (ECOG) 0-2

Exclusion Criteria:

- Previous cytotoxic or biologic treatment for AML (except hydroxyurea)

- Previous treatment with azacitidine, decitabine or cytarabine

- Prior use of targeted therapy agents (e.g., FLT3 inhibitors, other kinase inhibitors)

- AML French American British subtype (FAB M3)

- AML associated with inv(16), t(8;21), t(16;16), t(15:17), or t(9;22) karyotypes

- Prior bone marrow or stem cell transplantation

- Candidate for allogeneic bone marrow or stem cell transplant

- Diagnosis of malignant disease within the previous 12 months (excluding base cell
carcinoma, "in-situ" carcinoma of the cervix or breast or other local malignancy
excised or irradiated with a high probability of cure)

- Malignant hepatic tumors

- Uncontrolled systemic infection

- Active viral infection with Human Immunodeficiency Virus (HIV) or Hepatitis type B or
C

- Use of any experimental drug or therapy within 28 days prior to Day 1