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A Phase I/II Study of Combined Enrichment of CD34+ Cells and Depletion of B-Cells From Peripheral Blood Stem Cell Components for Patients With B-Lymphoid Malignancies (NCT00003874)

National Cancer Institute (NCI)
RATIONALE: Monoclonal antibodies can locate cancer cells and either kill them or deliver cancer-killing substances without harming normal cells. PURPOSE: Phase I/II trial to study the effectiveness of monoclonal antibody therapy in treating patients who have lymphoma or leukemia.
  • Biological: monoclonal antibody CD19
    • Biological: monoclonal antibody CD20
      • Procedure: in vitro-treated peripheral blood stem cell transplantation
        Ages eligible for Study
        up to 70 Years
        Genders eligible for Study
        All
        Accepts Healthy Volunteers
        No
        OBJECTIVES: I. Evaluate the efficiency of tumor cell removal by immunomagnetic technique in patients with B cell malignancies. II. Determine toxicity of mobilized peripheral blood stem cell (PBSC) components of enriched CD34+ and depleted B cells in this patient population. III. Compare recovery with the use of this treatment regimen to the use of unmanipulated PBSC or CD34+ PBSC components in this patient population.

        OUTLINE: Patients are assigned to one of two treatment arms for chemotherapy (chemotherapy protocol following FHCRC-506.2). Patients undergo mobilization and isolation of CD34+ cells as described in FHCRC-506.2. Peripheral blood stem cells are collected by apheresis and the CD34+ cells are isolated using magnetic beads. Monoclonal antibodies to CD19 and CD20 are added to the CD34+ cells to sensitize any remaining tumor cells. Patients undergo transplantation on day 0, according to applicable transplant protocols, one month after mobilization. Some patients may receive posttransplant interleukin-2 after achieving durable engraftment. Patients are followed at day 30, 80, 180, 365, and 395.

        PROJECTED ACCRUAL: A total of 20-30 patients will be accrued for this study.

        1 locations

        United States (1)
        • Fred Hutchinson Cancer Research Center
          Seattle, Washington, United States, 98109
        Status:
        completed
        Type:
        Interventional
        Phase:
        Ⅰ, Ⅱ
        Start:
        31 January, 1999
        Updated:
        27 November, 2011
        Participants:
        0
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