A Phase 3, Multicenter, Randomized, Open-Label, Study of Azacitidine (Vidaza®) Versus Conventional Care Regimens for the Treatment of Older Subjects With Newly Diagnosed Acute Myeloid Leukemia
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