Epratuzumab and Combination Chemotherapy in Treating Young Patients With Relapsed Acute Lymphoblastic Leukemia

Inclusion Criteria:

• Diagnosis of B-cell precursor acute lymphoblastic leukemia (ALL)

  • At least 25% expression of CD22 by immunophenotyping

  • In marrow relapse (M3 bone marrow) with or without associated extramedullary disease as defined by 1 of the following:

    • In first or later marrow relapse occurring any time after initial diagnosis (part A [closed to accrual as of 10/30/06] or B)
    • In first, early marrow relapse with or without associated extramedullary disease occurring < 36 months from the time of initial diagnosis (part B only)
• No B-cell L3 morphology OR evidence of MYC translocation by molecular or cytogenetic analysis
• No Down syndrome
• Patients with CNS or other extramedullary site involvement are allowed
• Performance status - Karnofsky 50-100% (for patients > 10 years of age)
• Performance status - Lansky 50-100% (for patients ≤ 10 years of age)
• WBC ≤ 50,000/mm^3 (part A only [closed to accrual as of 10/30/06])
• Bilirubin ≤ 1.5 times upper limit of normal (ULN)
• ALT ≤ 5 times ULN ( unless disease-related)
• Albumin ≥ 2 g/dL
• Creatinine clearance OR radioisotope glomerular filtration rate ≥ 70 mL/min

• Creatinine as defined by age as follows:

  • ≤ 0.5 mg/dL (for patients < 1 year old)
  • ≤ 0.8 mg/dL (for patients 1 to 5 years old)
  • ≤ 1.0 mg/dL (for patients 6 to 10 years old)
  • ≤ 1.2 mg/dL (for patients 11 to 15 years old)
  • ≤ 1.5 mg/dL (for patients > 15 years old)
• Shortening fraction ≥ 27% by echocardiogram
• Ejection fraction ≥ 45% by MUGA
• No dyspnea at rest
• No exercise intolerance
• Pulse oximetry > 94%
• No active or uncontrolled infection
• Not pregnant or nursing
• Negative pregnancy test
• Fertile patients must use effective contraception
• Recovered from prior immunotherapy
• At least 4 months since prior stem cell transplantation or rescue AND no evidence of active graft-vs-host disease
• At least 7 days since prior hematopoietic growth factors
• At least 7 days since prior biologic therapy*
• No other concurrent immunotherapy
• No other concurrent biologic therapy

• Recovered from prior chemotherapy

  • No waiting period for children who relapse while receiving standard ALL maintenance therapy
• No prior cumulative anthracycline exposure > 400 mg/m^2*
• No concurrent chemotherapy
• Recovered from prior radiotherapy
• No concurrent radiotherapy
• At least 2 days since prior hydroxyurea
• No other concurrent investigational drugs
• No other concurrent anticancer agents