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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


Brief Summary
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.

Detailed Description
OBJECTIVES: - To test whether the complete remission (CR) rate (CR and incomplete CR) in adult patients with relapsed or refractory precursor B-cell acute lymphoblastic leukemia is sufficiently high after treatment with cytarabine, clofarabine, and epratuzumab to warrant further investigation. - To estimate the frequency and severity of toxicities associated with the dosing schedule of cytarabine, clofarabine, and epratuzumab used in this study. - To investigate, preliminarily, the effect of laboratory correlates (minimal post-treatment residual disease) and cytogenetic factors on prognosis in this patient population. (Not reported here due to limited MRD data) OUTLINE: This is a multicenter study. Patients receive cytarabine IV over 2 hours on days 1-5, clofarabine IV over 1 hour on days 2-6, and epratuzumab IV over at least 1 hour on days 7, 14, 21, and 28 in the absence of disease progression or unacceptable toxicity*. NOTE: * Prophylactic intrathecal methotrexate is required for patients < 22 years of age, and is recommended (but not required) for patients ≥ 22 years of age. Blood samples, bone marrow samples, and/or tumor tissue samples may be collected for further laboratory analysis. Patients are followed up every 3 months for 2 years, then annually for 3 years (until 5 years after registration).


Phase 2 - takes the treatment one step further, assessing the activity of a particular therapy in a disease, often building upon leads from the Phase I trial. While patients are generally required to be previously untreated, participation in a Phase II trial doesn't usually preclude the patient from getting the standard treatment after they've received the investigational agent. At best they are allowed to get a new drug they wouldn't be able to get otherwise that may turn out to be better for their disease.

Inclusion and Exclusion Criteria

  • 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)


  • Utah

    • Dixie Regional Medical Center - East Campus, Saint George, Utah, 84770
    • Sandra L. Maxwell Cancer Center, Cedar City, Utah, 84720
    • Utah Valley Regional Medical Center - Provo, Provo, Utah, 84604
    • American Fork Hospital, American Fork, Utah, 84003
    • Jon and Karen Huntsman Cancer Center at Intermountain Medical Center, Murray, Utah, 84157
    • LDS Hospital, Salt Lake City, Utah, 84143
    • Val and Ann Browning Cancer Center at McKay-Dee Hospital Center, Ogden, Utah, 84403
    • Logan Regional Hospital, Logan, Utah, 84321
  • California

    • University of California Davis Cancer Center, Sacramento, California, 95817
  • Colorado

    • St. Mary's Regional Cancer Center at St. Mary's Hospital and Medical Center, Grand Junction, Colorado, 81502
    • University of Colorado Cancer Center at UC Health Sciences Center, Aurora, Colorado, 80045
  • Washington

    • Columbia Basin Hematology, Kennewick, Washington, 99336
    • Cancer Care Northwest - Spokane South, Spokane, Washington, 99202
    • University Cancer Center at University of Washington Medical Center, Seattle, Washington, 98195
    • Evergreen Hematology and Oncology, PS, Spokane, Washington, 99218
    • Highline Medical Center Cancer Center, Burien, Washington, 98166
    • Swedish Medical Center - Issaquah Campus, Issaquah, Washington, 98029
    • Polyclinic First Hill, Seattle, Washington, 98122
    • Group Health Central Hospital, Seattle, Washington, 98112
    • Fred Hutchinson Cancer Research Center, Seattle, Washington, 98109
    • Olympic Hematology and Oncology, Bremerton, Washington, 98310
    • Harrison Poulsbo Hematology and Onocology, Poulsbo, Washington, 98370
    • Skagit Valley Hospital Cancer Care Center, Mount Vernon, Washington, 98274
    • North Puget Oncology at United General Hospital, Sedro-Woolley, Washington, 98284
    • Island Hospital Cancer Care Center at Island Hospital, Anacortes, Washington, 98221
    • St. Joseph Cancer Center, Bellingham, Washington, 98225
  • Montana

    • Bozeman Deaconess Cancer Center, Bozeman, Montana, 59715
    • Montana Cancer Center at St. Patrick Hospital and Health Sciences Center, Missoula, Montana, 59807
    • St. Peter's Hospital, Helena, Montana, 59601
    • Hematology-Oncology Centers of the Northern Rockies - Billings, Billings, Montana, 59102
    • St. Vincent Healthcare Cancer Care Services, Billings, Montana, 59101
    • CCOP - Montana Cancer Consortium, Billings, Montana, 59101
    • Sletten Cancer Institute at Benefis Healthcare, Great Falls, Montana, 59405
    • Great Falls Clinic - Main Facility, Great Falls, Montana, 59405
    • Glacier Oncology, PLLC, Kalispell, Montana, 59901
    • Kalispell Regional Medical Center, Kalispell, Montana, 59901
  • Wyoming

    • Welch Cancer Center at Sheridan Memorial Hospital, Sheridan, Wyoming, 82801
  • Texas

    • Baylor University Medical Center - Houston, Houston, Texas, 77030
    • Ben Taub General Hospital, Houston, Texas, 77030
    • Veterans Affairs Medical Center - Houston, Houston, Texas, 77030
    • St. Luke's Texas Cancer Institute at St. Luke's Episcopal Hospital, Houston, Texas, 77030
  • Arkansas

    • Arkansas Cancer Research Center at University of Arkansas for Medical Sciences, Little Rock, Arkansas, 72205
  • Missouri

    • Saint Louis University Cancer Center, Saint Louis, Missouri, 63110
  • Louisiana

    • Hematology-Oncology Clinic, Baton Rouge, Louisiana, 70809
  • Mississippi

    • University of Mississippi Cancer Clinic, Jackson, Mississippi, 39216
  • Illinois

    • Cardinal Bernardin Cancer Center at Loyola University Medical Center, Maywood, Illinois, 60153
  • Indiana

    • St. Francis Hospital and Health Centers - Beech Grove Campus, Beech Grove, Indiana, 46107
    • Reid Hospital & Health Care Services, Richmond, Indiana, 47374
  • Ohio

    • Wayne Hospital, Greenville, Ohio, 45331
    • Charles M. Barrett Cancer Center at University Hospital, Cincinnati, Ohio, 45267
    • Samaritan North Cancer Care Center, Dayton, Ohio, 45415
    • Good Samaritan Hospital, Dayton, Ohio, 45406
    • Grandview Hospital, Dayton, Ohio, 45405
    • David L. Rike Cancer Center at Miami Valley Hospital, Dayton, Ohio, 45409
    • Charles F. Kettering Memorial Hospital, Kettering, Ohio, 45429
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