A Phase IIB, Randomized, Double-Blinded, Placebo-Controlled Study of Low Dose Cytarabine and Lintuzumab Compared to Low Dose Cytarabine and Placebo in Patients 60 Years of Age and Older With Previously Untreated AML

Inclusion Criteria:

- Untreated AML that occurred de novo, after prior exposure to chemotherapy for a
separate malignancy, or evolved from an antecedent hematologic disorder.

- After being informed of the potential benefits and risks of available treatment
options, patients must have declined intensive chemotherapy for AML.

- At least 20% blasts in blood or marrow.

- Must have a minimum of 50% leukemic blasts that express CD33.

- ECOG performance status score of 0 to 2.

- WBC less than 30,000/µL

Exclusion Criteria:

- No known diagnosis of acute promyelocytic leukemia or chronic myeloid leukemia.

- No other active systemic malignancies treated with chemotherapy within the last 12
months.

- Must not have received previous chemotherapy (except hydroxyurea) for AML.

- Must not have significantly abnormal kidney or liver disease.

- Must not have known human immunodeficiency virus (HIV).