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

Not Recruiting

Trial ID: NCT00945815


RATIONALE: Monoclonal antibodies, such as epratuzumab, can block cancer growth in different ways. Some block the ability of cancer cells to grow and spread. Others find cancer cells and help kill them or carry cancer-killing substances to them. Drugs used in chemotherapy, such as cytarabine and clofarabine, work in different ways to stop the growth of cancer cells, either by killing the cells or by stopping them from dividing. Giving epratuzumab together with cytarabine and clofarabine may kill more cancer cells. PURPOSE: This phase II trial is studying the side effects and how well giving epratuzumab together with cytarabine and clofarabine works in treating patients with relapsed or refractory acute lymphoblastic leukemia.

Official Title

S0910, A Phase II Study of Epratuzumab (NSC-716711) in Combination With Cytarabine and Clofarabine for Patients With Relapsed or Refractory Ph- Negative Precursor B-Cell Acute Lymphoblastic Leukemia

Stanford Investigator(s)

Michaela Liedtke
Michaela Liedtke

Associate Professor of Medicine (Hematology)

Caroline Berube
Caroline Berube

Clinical Associate Professor, Medicine - Hematology

Jason Gotlib

Professor of Medicine (Hematology)



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

      - 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

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

   - 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

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


   - 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


   - 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

      - 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)


drug: cytarabine

drug: clofarabine

biological: epratuzumab

other: laboratory biomarker analysis

Not Recruiting

Contact Information

Stanford University
School of Medicine
300 Pasteur Drive
Stanford, CA 94305
Cancer Clinical Trials Office

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