Idarubicin and High-Dose Cytarabine in Treating Patients With Acute Myeloid Leukemia

OBJECTIVES:

• Determine the complete remission rate (CR).
• Determine the proportion of patients who are bone marrow-positive at day 7 post-induction chemotherapy.
• Further evaluate the toxicity of this regimen.

OUTLINE: Patients receive cytarabine IV over 3 hours every 12 hours on days 1-4 and idarubicin IV over 5-10 minutes on days 1-3. Patients undergo bone marrow aspirate and biopsy 7 days after completion of induction chemotherapy. Patients with > 25% cellular biopsy or > 10% abnormal cells on aspirate receive 4 more doses of cytarabine and 1 dose of idarubicin.

DISEASE CHARACTERISTICS:

Inclusion criteria

• Newly diagnosed acute myeloid leukemia (AML)

• Morphologic proof (bone marrow aspirate smears or touch prep of marrow biopsy) of disease
• FAB M0, M1, M2, M4, M5a, M5b, M6a, M6b, and M7 disease
• Previously untreated with radiotherapy or chemotherapy

• Patients with treatment-related leukemia are eligible even if they have received prior chemotherapy and radiotherapy
• Patients with prior myelodysplastic syndrome are eligible
• Extramedullary leukemia allowed
• AML with lymphoid markers allowed

Exclusion criteria

• Blastic transformation of chronic myelogenous leukemia
• Biphenotypic leukemia
• FAB M3 disease (acute promyelocytic leukemia)

PATIENT CHARACTERISTICS:

• Life expectancy ≥ 6 weeks
• Total bilirubin < 1.5 g/dL
• AST and ALT < 5 times upper limit of normal (ULN)
• Creatinine < 1.5 mg/dL OR creatinine clearance > 70 mL/min
• Ejection fraction ≥ 50% by MUGA unless decreased ejection fraction is secondary to leukemia infiltration
• HIV antibody-negative

PRIOR CONCURRENT THERAPY:

Inclusion criteria

• See Disease Characteristics
• Prior hydroxyurea or corticosteroids allowed
• At least 48 hours since prior and no concurrent itraconazole or fluconazole

Exclusion criteria

• More than 300 mg/m² of prior daunorubicin or equivalent dose of anthracycline