A Phase II Open-Label Study of High-Dose Cytarabine and Clofarabine in Adult Patients With Refractory or Relapsed Acute Myelogenous Leukemia or Refractory or Relapsed Acute Lymphoblastic Leukemia

DISEASE CHARACTERISTICS:

• Pathologic confirmation of acute myeloid leukemia (AML) or acute lymphoblastic leukemia (ALL)

  • No M3 AML

• Meets 1 of the following criteria:

  • In first relapse
  • In second relapse after a second complete remission (CR) that lasted ≥ 3 months
  • Refractory to initial induction therapy
• No symptomatic CNS involvement

PATIENT CHARACTERISTICS:

• ECOG performance status ≤ 2
• Creatinine < 2 mg/dL
• Bilirubin ≤ 2 mg/dL
• AST and ALT ≤ 4 times upper limit of normal
• Not pregnant or nursing
• Negative pregnancy test
• Fertile patients must use effective contraception during and for 2 weeks after completing study treatment
• Ejection fraction ≥ 45% by echocardiogram
• No active, uncontrolled systemic infection considered opportunistic, life-threatening, or clinically significant
• No psychiatric disorders that would interfere with giving consent, study participation, or follow-up procedures
• No other severe concurrent disease that would preclude study treatment

PRIOR CONCURRENT THERAPY:

• At least 1 week since prior therapy and recovered

• No other concurrent chemotherapy

  • Hydroxyurea to control WBC count before starting study treatment allowed
• No concurrent corticosteroids unless used for diseases other than leukemia
• No concurrent palliative radiotherapy
• No concurrent growth factors (e.g., epoetin alfa, filgrastim [G-CSF], or sargramostim [GM-CSF]) in patients with AML