Rituximab in indolent lymphoma: the single-agent pivotal trial

Semin Oncol. 1999 Oct;26(5 Suppl 14):79-87.

Abstract

Rituximab (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.

Publication types

  • Clinical Trial
  • Multicenter Study
  • Research Support, Non-U.S. Gov't
  • Research Support, U.S. Gov't, P.H.S.

MeSH terms

  • Antibodies, Monoclonal / pharmacokinetics
  • Antibodies, Monoclonal / therapeutic use*
  • Antibodies, Monoclonal, Murine-Derived
  • Antigens, CD20
  • Antineoplastic Agents / pharmacokinetics
  • Antineoplastic Agents / therapeutic use*
  • Female
  • Humans
  • Lymphoma, B-Cell / drug therapy*
  • Lymphoma, B-Cell / immunology
  • Male
  • Middle Aged
  • Rituximab
  • Survival Analysis

Substances

  • Antibodies, Monoclonal
  • Antibodies, Monoclonal, Murine-Derived
  • Antigens, CD20
  • Antineoplastic Agents
  • Rituximab