galiximab的I / II期研究anti-CD80抗体,复发或难治性滤泡淋巴瘤。
文章的细节
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引用
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Czuczman女士,Thall通过TE,沃斯JM,尤尼斯,Emmanouilides C,米勒TP,摩尔乔,伦纳德摩根大通,戈登•李Sweetenham J, Alkuzweny B,芬努凯恩DM,利BR
galiximab的I / II期研究anti-CD80抗体,复发或难治性滤泡淋巴瘤。
肿瘤防治杂志。2005年7月1;23 (19):4390 - 8。
- PubMed ID
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15994148 (在PubMed]
- 文摘
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目的:这个多中心,增大剂量研究评估安全,药物动力学,功效galiximab (anti-CD80单克隆抗体)患者复发或难治性滤泡淋巴瘤。患者和方法:患者滤泡淋巴瘤复发或未能应对主要治疗;绝大多数(90%)处于III或IV期。4周静脉输液galiximab服用剂量的125,250,375,或500 mg / m2。结果:37例接受galiximab治疗和评估安全;35是应税的回应。抗体注入是安全的和没有dose-limiting毒性的耐受性良好。共22个(60%)的患者37 galiximab相关的不良事件。除了一个1或2级事件;最常见的是疲劳、恶心和头痛。 Cytopenias were rare; only one patient experienced anemia and febrile neutropenia, which were unrelated to galiximab and resolved after treatment. No patient developed antigaliximab antibody formation. The mean serum half-life ranged from 13 to 24 days. The overall response rate was 11% (two complete responses and two partial responses). Time to best response was delayed (months 3, 6, 9, and 12). Twelve patients (34%) maintained stable disease. Nearly half of all patients (49%) had a decrease in indicator lesions. Two responders remain on study without progression (22 and 24.4 months). CONCLUSION: The favorable safety profile of galiximab and evidence of single-agent biologic activity and dose-dependent pharmacokinetics support further evaluation of galiximab as a treatment for follicular lymphoma, possibly in combination with other lymphoma therapies.
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- 药物
- 药物靶点
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药物 目标 类 生物 药理作用 行动 Galiximab 早期活化抗原CD80 蛋白质 人类 是的抗体细节