A Phase II Trial of Azacitidine (NSC-102816) Plus Gemtuzumab Ozogamicin (NSC-720568) as Induction and Post-Remission Therapy in Patients of Age 60 and Older With Previously Untreated Non-M3 Acute Myeloid Leukemia.

Inclusion Criteria:

- Morphologically confirmed diagnosis of acute myeloidleukemia (AML)

- No acute promyelocytic leukemia (FAB M3)

- No blastic transformation of chronic myelogenous leukemia

- Patients with a history of prior myelodysplastic syndrome (MDS) are eligible
according to the following criteria:

- No prior treatment of MDS with AML induction-type chemotherapy or high-dose
chemotherapy with hematopoietic stem cell support

- Prior cytarabine allowed if dose < 100 mg/m^2/day

- Prior hematopoietic growth factors, thalidomide, lenalidomide, arsenic trioxide,
and signal transduction inhibitors for treatment of MDS allowed

- No prior treatment with azacitidine, decitabine, or gemtuzumab ozogamicin

- At least 30 days since prior therapy for MDS and recovered

- Must be registered on SWOG-S9910

- No CNS involvement

- Zubrod performance status 0-3

- Total bilirubin ≤ 2.0 times upper limit of normal (ULN) (unless the elevation is
believed to be due to hepatic infiltration by AML)

- Hyperbilirubinemia due primarily to elevated unconjugated hyperbilirubinemia
secondary to Gilbert syndrome or hemolysis allowed

- AST or ALT ≤ 2.0 times ULN (unless the elevation is believed to be due to hepatic
infiltration by AML)

- Serum creatinine ≤ 1.5 times ULN

- LVEF ≥ 40% by MUGA or ECHO AND no clinical evidence of congestive heart failure
within the past 56 days

- No known hypersensitivity to azacitidine, mannitol, hydroxyurea, orgemtuzumab
ozogamicin

- Negative pregnancy test

- Not pregnant or nursing

- Fertile patients must use effective contraception

- HIV-positive patients must meet the following criteria:

- No history of AIDS-defining events

- CD4 cells ≥ 500/mm^3

- Viral load of < 50 copies HIV mRNA/mm^3 if on cART or < 25,000 copiesHIV mRNA if
not on cART

- No zidovudine or stavudine as part of cART

- No other prior malignancy except for adequately treated basal cell or squamous cell
skin cancer or any diagnosis of malignancy made within the past 2 years of which
there is no clinically evident cancer, and for which the patient has completed all
chemotherapy and radiotherapy at least 6 months prior to study registration

- Concurrent hormonal therapy allowed

- At least 6 months since prior chemotherapy or radiotherapy

- No prior systemic chemotherapy for acute leukemiaexcept hydroxyurea

- Prior hydroxyurea to control high WBC count allowed