Phase I study of a modified regimen of ⁹⁰Yttrium-ibritumomab tiuxetan for relapsed or refractory follicular or transformed CD20+ non-Hodgkin lymphoma

Cancer Biother Radiopharm. 2013 Jun;28(5):370-9. doi: 10.1089/cbr.2012.1387. Epub 2013 Mar 26.

Abstract

Radioimmunotherapy capitalizes on the radiosensitivity of non-Hodgkin lymphoma (NHL) and the targeted nature of monoclonal antibodies. In an attempt to reverse bone marrow infiltration with B-cells and optimize the biodistribution of Yttrium-90 (⁹⁰Y)-ibritumomab tiuxetan, we conducted a phase I study combining a single course of ⁹⁰Y-ibritumomab tiuxetan after a 4-weekly course of rituximab in relapsed or refractory low-grade or transformed CD20+ B-cell NHLs with <25% marrow involvement. The 0.4 mCi/kg dose was associated with 80% grade-4 cytopenias. Dose escalation was held, and 6 patients were enrolled at a 0.3 mCi/kg cohort. As the 0.3 mCi/kg dose was well tolerated, the 0.4 mCi/kg cohort was expanded to 6 additional patients. In the expansion cohort, grade-4 cytopenia developed in 33%. Further dose escalation was held, and the maximum tolerated dose was determined at 0.4 mCi/kg. With this regimen, marrow involvement decreased in all patients with complete clearance in 50%. The overall response rate was 82%. With a median follow-up of 31.7 months, the median progression-free survival and time to next treatment were 12.3 and 10.9 months, respectively. Although this regimen was associated with a high response rate, the hematologic toxicity was higher than with the standard ⁹⁰Y-ibritumomab tiuxetan regimen.

Publication types

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

MeSH terms

  • Adult
  • Aged
  • Antibodies, Monoclonal / pharmacokinetics
  • Antibodies, Monoclonal / therapeutic use*
  • Antigens, CD20 / metabolism*
  • Drug Resistance, Neoplasm*
  • Female
  • Humans
  • Lymphoma, Non-Hodgkin / immunology
  • Lymphoma, Non-Hodgkin / mortality
  • Lymphoma, Non-Hodgkin / therapy*
  • Male
  • Maximum Tolerated Dose
  • Middle Aged
  • Neoplasm Grading
  • Neoplasm Recurrence, Local / immunology
  • Neoplasm Recurrence, Local / mortality
  • Neoplasm Recurrence, Local / therapy*
  • Neoplasm Staging
  • Prognosis
  • Radioimmunotherapy*
  • Salvage Therapy*
  • Survival Rate
  • Tissue Distribution
  • Yttrium Radioisotopes

Substances

  • Antibodies, Monoclonal
  • Antigens, CD20
  • Yttrium Radioisotopes
  • ibritumomab tiuxetan