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Rituximab (IDEC-C2B8, Mabthera) in Patients With Hairy Cell Leukemia Relapsing After Treatment With 2-Chlorodeoxyadenosine (CDA) (NCT00003757)

RATIONALE: Monoclonal antibodies can locate tumor cells and either kill them or deliver tumor-killing substances to them without harming normal cells. PURPOSE: Phase II trial to study the effectiveness of monoclonal antibody therapy consisting of rituximab in treating patients with refractory or recurrent hairy cell leukemia following cladribine therapy.
  • Biological: rituximab
    Ages eligible for Study
    18 Years and older
    Genders eligible for Study
    All
    Accepts Healthy Volunteers
    No
    OBJECTIVES:

    - Determine the rate of complete and partial remission, remission duration, and relapse free survival after treatment with rituximab in patients with refractory or recurrent hairy cell leukemia who previously received cladribine.

    - Determine the acute and long term toxicity of rituximab in these patients.

    OUTLINE: This is an open-label, multicenter study.

    Patients receive rituximab IV over several hours once a week for 4 weeks.

    Patients are followed every 3 months for 3 years and every 6 months thereafter.

    PROJECTED ACCRUAL: A total of 8-25 patients will be accrued for this study within 3 years.

    1 locations

    Switzerland (1)
    • Klinik Hirslanden
      Not specified
      Zurich, Switzerland, CH-8008
    Status:
    completed
    Type:
    Interventional
    Phase:
    Start:
    31 January, 1998
    Updated:
    13 May, 2012
    Participants:
    25
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