• Seminars in oncology · Oct 1999

    Multicenter Study Clinical Trial

    Rituximab in indolent lymphoma: the single-agent pivotal trial.

    • P McLaughlin, F B Hagemeister, and A J Grillo-López.
    • Department of Lymphoma/Myeloma, University of Texas M.D. Anderson Cancer Center, Houston 77030, USA.
    • Semin. Oncol. 1999 Oct 1; 26 (5 Suppl 14): 79-87.

    AbstractRituximab (Rituxan; IDEC Pharmaceuticals, San Diego, CA, and Genentech, Inc, San Francisco, CA) is a chimeric anti-CD20 monoclonal antibody that targets mature B cells and most B-cell malignancies. Rituximab was the first monoclonal antibody to be approved for therapeutic use for any malignancy. Its approval was based on a single-agent pivotal trial in patients with indolent B-cell lymphoma, in which 166 patients were enrolled from 31 centers in the United States and Canada. The overall results of the trial have been previously reported; additional aspects of the trial (eg, pharmacokinetics) have been reported separately as well. The current report includes an update, expansion, and synthesis of data from the single-agent pivotal trial of rituximab.

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