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

Carpenter PA, Lowder J, Johnston L, Frangoul H, Khoury H, Parker P, Jerome KR, McCune JS, Storer B, Martin P, Appelbaum F, Abonour R, Westervelt P, Anasetti C
Biol Blood Marrow Transplant. 2005 11 (6): 465-71

PMID: 15931635 · DOI:10.1016/j.bbmt.2005.03.002

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.

MeSH Terms (17)

Acute Disease Adolescent Adult Aged Antibodies, Monoclonal Antibodies, Monoclonal, Humanized Child Child, Preschool Female Graft vs Host Disease Hematologic Neoplasms Hematopoietic Stem Cell Transplantation Humans Male Middle Aged Steroids Survival Analysis

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