Study of Biomarker-Based Treatment of Acute Myeloid Leukemia

Inclusion Criteria:

- Adults, age 60 years or older at the time of diagnosis

- Subjects or their legal representative must be able to understand and provide written
informed consent

- Cohort Inclusion Criteria - Group A: Subjects must have previously untreated acute
myeloid leukemia (AML) according to the WHO classification with no prior treatment
other than hydroxyurea. Prior therapy for myelodysplastic syndrome (MDS),
myeloproliferative syndromes (MPD), or aplastic anemia is permitted but not with
hypomethylating agents.

- Cohort Inclusion Criteria - Group B: Subjects must have relapsed or refractory AML
according to the WHO classification. For study purposes, refractory AML is defined as
failure to ever achieve CR or recurrence of AML within 6 months of achieving CR;
relapsed AML is defined as all others with disease after prior remission. (Group B is
not currently recruiting.)

Exclusion Criteria:

- Isolated myeloid sarcoma (meaning, patients must have blood or marrow involvement with
AML to enter the study)

- Acute promyelocytic leukemia

- Symptomatic central nervous system (CNS) involvement by AML

- Signs of leukostasis requiring urgent therapy

- Disseminated intravascular coagulopathy with active bleeding or signs of thrombosis

- Patients with psychological, familial, social, or geographic factors that otherwise
preclude them from giving informed consent, following the protocol, or potentially
hamper compliance with study treatment and follow-up

- Any other significant medical condition, including psychiatric illness or laboratory
abnormality, that would preclude the patient participating in the trial or would
confound the interpretation of the results of the trial