Chemoimmunotherapy With Epratuzumab in Relapsed Acute Lymphoblastic Leukemia (ALL)

Inclusion Criteria:

   - Diagnosis of B lymphoblastic leukemia (B-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 a regulator gene that codes for a transcription
   factor (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)

   - White Blood Count (WBC) ≤ 50,000/mm^3 (part A only [closed to accrual as of 10/30/06])

   - Bilirubin ≤ 1.5 times upper limit of normal unless disease-related (ULN)

   - Alanine aminotransferase (ALT) ≤ 5 times ULN

   - 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 Multi Gated Acquisition Scan (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