A phase II multicenter study of visilizumab, humanized anti-CD3 antibody, to treat steroid-refractory acute graft-versus-host disease
A phase II multicenter study of visilizumab, humanized anti-CD3 antibody, to treat steroid-refractory acute graft-versus-host disease
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DOI：
10.1016/j.bbmt.2005.03.002
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发表时间：
2005-06-01
影响因子：
4.3
通讯作者：
Anasetti, C
中科院分区：
文献类型：
--
作者：
Carpenter, PA;Lowder, J;Anasetti, C
先前的一项I期研究结果表明，单次3mg /m(2)剂量的人源化非fr结合抗cd3单克隆抗体visilizumab （Nuvion）耐受性良好，对治疗类固醇难治性急性移植物抗宿主病（GVHD）有效。我们现在报告一项多中心II期研究的结果，在该研究中，44名患有类固醇难治性急性GVHD的参与者使用了visilizumab。82%的参与者有内脏受累，86%的参与者在研究开始时患有III级或IV级急性GVHD。42天的完全缓解率和总缓解率分别为14%和32%。在19名受试者的血浆中，爱泼斯坦-巴尔病毒DNA增加到每毫升1000多份。17例接受利妥昔单抗治疗，未见致死性淋巴增生性疾病。180天生存率为32%（95%置信区间，18%-46%）。本研究中使用的visilizumab似乎足够安全有效，值得进一步评估治疗或预防GVHD。(c) 2005年美国血液和骨髓移植学会。
Results of a previous phase I study suggested that a single 3 mg/m(2) 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. (c) 2005 American Society for Blood and Marrow Transplantation.