Cytarabine and Daunorubicin With or Without Gemtuzumab Ozogamicin in Treating Older Patients With Acute Myeloid Leukemia or Myelodysplastic Syndromes

DISEASE CHARACTERISTICS:

• Histologically or cytologically confirmed diagnosis of 1 of the following:

  • Acute myeloid leukemia (AML)

    • M0-M2 or M4-M7 FAB subtype

      • No AML with cytogenetic abnormality t(15;17) (M3)
    • Patients with secondary AML progressing from prior myelodysplasia* or biphenotypic leukemia are eligible

  • Refractory anemia with excess blasts (RAEB) or RAEB in transformation

    • International Prognostic Scoring System score ≥ 1.5 NOTE: *Any prior hematological disease of ≥ 4 months duration
• No chronic myelogenous leukemia in blastic crisis
• No prior polycythemia rubra vera
• No primary myelofibrosis

PATIENT CHARACTERISTICS:

Age

• 61 and over

Performance status

• WHO 0-2

Life expectancy

• Not specified

Hematopoietic

• Not specified

Hepatic

• ALT and/or AST ≤ 2.5 times upper limit of normal (ULN)*
• Bilirubin ≤ 2 times ULN* NOTE: *Unless elevation is caused by organ infiltration by AML

Renal

• Creatinine ≤ 2 times ULN* NOTE: *Unless elevation is caused by organ infiltration by AML

Cardiovascular

• No myocardial infarction within the past 6 months
• LVEF > 50% by MUGA, echocardiogram, or other methods
• No unstable angina
• No unstable cardiac arrhythmia
• No severe and/or uncontrolled hypertension

Other

• No uncontrolled diabetes
• No severe and/or uncontrolled infection
• No other severe and/or uncontrolled medical condition

PRIOR CONCURRENT THERAPY:

Biologic therapy

• Not specified

Chemotherapy

• More than 6 months since prior chemotherapy

Endocrine therapy

• Not specified

Radiotherapy

• Not specified

Surgery

• Not specified

Other

• No prior induction therapy for AML or myelodysplastic syndromes