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SWOG-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 (ALL)

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

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)

Sites

  • 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

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