S0910 Epratuzumab, Cytarabine, and Clofarabine in Treating Patients With Relapsed or Refractory Acute Lymphoblastic Leukemia

DISEASE CHARACTERISTICS:

   - Morphologically confirmed precursor B-cell acute lymphoblastic leukemia (ALL) (non
   T-cell)

      - Must have evidence of disease in bone marrow or peripheral blood

         - Immunophenotyping of the blood or marrow lymphoblasts must be performed to
         determine lineage (B cell, T cell, or mixed B/T cell)

         - Must have ≥ 5% lymphoblasts present in the blood or bone marrow

         - At least 20% of marrow and/or peripheral blood lymphoblasts must be CD22+ by
         flow cytometry

            - Co-expression of myeloid antigens (CD13 and CD33) allowed

         - Patients with only extramedullary disease in the absence of bone marrow or
         blood involvement are not eligible

   - Philadelphia (Ph) chromosome-negative disease

      - Patients with unknown Ph status by cytogenetics or FISH and unknown BCR/ABL
      status by PCR are eligible for study registration, but must be removed from study
      therapy if found to be Ph+ or BCR/ABL+ after study registration

   - Refractory to a standard induction regimen that included vincristine and prednisone or
   high-dose cytarabine or mitoxantrone OR relapsed after successful prior induction
   therapy

      - Any number of prior induction therapies or any number of remissions achieved are
      allowed

   - No M0 acute myeloid leukemia, mixed lineage leukemia, or L3 (Burkitt) leukemia

   - No active CNS involvement by clinical evaluation

      - Patients with a documented history of CNS involvement of ALL or with clinical
      signs or symptoms consistent with CNS involvement of ALL must undergo a lumbar
      puncture that is negative for CNS involvement of ALL

   - Patients < 22 years of age must be willing to receive prophylactic intrathecal
   chemotherapy

   - Must be registered on SWOG-9007 "Cytogenetic Studies in Leukemia Patients" (closed as
   of 07/01/2010)

PATIENT CHARACTERISTICS:

   - Zubrod performance status 0-2

   - Serum creatinine ≤ 1.0 mg/dL OR glomerular filtration rate > 60 mL/min

   - AST and ALT ≤ 2.5 times upper limit of normal (ULN)

   - Alkaline phosphatase ≤ 2.5 times ULN

   - Bilirubin ≤ 1.5 times ULN

   - Not pregnant or nursing

   - Fertile patients must use effective contraception during and for ≥ 6 months after
   completion of study treatment

   - HIV-positive patients are eligible (at the discretion of the investigator) provided
   the following criteria are met:

      - No history of AIDS-defining conditions

      - CD4 cell count > 350/mm³

      - If on antiretroviral agents, must not include zidovudine or stavudine

      - Willing to receive prophylaxis for pneumocystis jirovecii pneumonia during study
      therapy (regardless of CD4 cell count) until the CD4 cell count is > 200/mm³
      after completion of study treatment

   - Prior malignancy (other than ALL) allowed provided it is in remission and there are no
   plans to treat the malignancy at the time of study registration

   - No uncontrolled systemic fungal, bacterial, viral, or other infection, defined as
   exhibiting ongoing signs or symptoms related to the infection with no improvement
   despite appropriate antibiotics or other treatment

   - No neuropathy (cranial, motor or sensory) ≥ grade 2

PRIOR CONCURRENT THERAPY:

   - See Disease Characteristics

   - Any number of prior therapies allowed

   - More than 90 days since prior allogeneic bone marrow transplant (BMT)

      - No concurrent immunosuppression therapy for the treatment of graft-vs-host
      disease (GVHD)

      - No acute GVHD ≥ grade 2, moderate or severe limited chronic GVHD, or extensive
      chronic GVHD of any severity

   - Prior autologous BMT allowed

      - No concurrent immunosuppression therapy for the treatment of GVHD

   - More than 14 days since prior chemotherapy, investigational agents, or major surgery
   and recovered

      - Maintenance therapy with steroids, vincristine, and/or anti-metabolite agents,
      including but not limited to, mercaptopurine, thioguanine, and methotrexate
      allowed

      - Concurrent hydroxyurea to reduce WBC to a reasonable level (as deemed by the
      treating physician) allowed

   - No prior clofarabine or epratuzumab

   - No other concurrent cytotoxic therapy or investigational therapy

   - No concurrent alternative medications (e.g., herbal or botanical medications for
   anticancer purposes)

   - Concurrent participation on SWOG-S9910 "Leukemia Centralized Reference Laboratories
   and Tissue Repositories, Ancillary" allowed (closed as of 07/01/2010)