A phase II multicenter study of visilizumab, humanized anti-CD3 antibody, to treat steroid-refractory acute graft-versus-host disease

Paul A. Carpenter, James Lowder, Laura Johnston, Haydar Frangoul, Hanna Khoury, Pablo Parker, Keith R. Jerome, Jeannine S. McCune, Barry Storer, Paul Martin, Frederick Appelbaum, Rafat Abonour, Peter Westervelt, Claudio Anasetti

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75 Scopus citations

Abstract

Results of a previous phase I study suggested that a single 3 mg/m2 dose of the humanized non-FcR-binding anti-CD3 monoclonal antibody visilizumab (Nuvion) was well tolerated and had efficacy for the treatment of steroid-refractory acute graft-versus-host disease (GVHD). We now report results of a multicenter phase II study in which visilizumab was given to 44 participants with steroid-refractory acute GVHD. Eighty-two percent of the participants had visceral involvement, and 86% had overall grade III or IV acute GVHD at study entry. The respective complete and overall response rates were 14% and 32% at 42 days. Plasma Epstein-Barr virus DNA increased to more than 1000 copies per milliliter in 19 subjects. Seventeen received rituximab, and no fatal lymphoproliferative disorders were observed. Survival at 180 days was 32% (95% confidence interval, 18%-46%). The administration of visilizumab as used in this study seems to be sufficiently safe and effective to warrant further assessment for treatment or prevention of GVHD.

Original languageEnglish
Pages (from-to)465-471
Number of pages7
JournalBiology of Blood and Marrow Transplantation
Volume11
Issue number6
DOIs
StatePublished - Jun 1 2005
Externally publishedYes

Keywords

  • Anti-CD3
  • Graft-versus-host disease
  • Hematopoietic cell transplantation
  • Monoclonal antibody
  • Steroid refractory
  • Visilizumab

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    Carpenter, P. A., Lowder, J., Johnston, L., Frangoul, H., Khoury, H., Parker, P., Jerome, K. R., McCune, J. S., Storer, B., Martin, P., Appelbaum, F., Abonour, R., Westervelt, P., & Anasetti, C. (2005). A phase II multicenter study of visilizumab, humanized anti-CD3 antibody, to treat steroid-refractory acute graft-versus-host disease. Biology of Blood and Marrow Transplantation, 11(6), 465-471. https://doi.org/10.1016/j.bbmt.2005.03.002