galiximab I / II期研究(anti-CD80单克隆抗体)与利妥昔单抗治疗复发或难治性滤泡淋巴瘤。

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伦纳德摩根大通,弗里德伯格JW,尤尼斯,费舍尔D,戈登•李摩尔J, Czuczman M,米勒T, P,僵硬Cheson BD, Forero-Torres, Chieffo N, McKinney B,芬努凯恩D,莫利纳

galiximab I / II期研究(anti-CD80单克隆抗体)与利妥昔单抗治疗复发或难治性滤泡淋巴瘤。

安杂志。2007;18(7):1216 - 23所示。Epub 2007年4月29日。

PubMed ID
17470451 (在PubMed
]
文摘

背景:Galiximab CD80单克隆抗体,目标,costimulatory分子结构上表达了在滤泡和其他淋巴瘤。适度单药临床活动和耐受性演示了一个阶段我研究在复发或难治性滤泡性非霍奇金淋巴瘤(NHL)。I / II期研究评估galiximab结合标准的利妥昔单抗。安全、药物动力学、和有效性进行评估。病人和方法:卵泡NHL患者复发或失败为主要治疗。Rituximab-refractory患者(无响应或响应时间< 6个月)进展被排除在外。患者接受4周静脉输液注入galiximab(125, 250, 375,或500毫克/米(2))和利妥昔单抗(375毫克/米(2))。国际研讨会反应标准(IWRC)被用来评估响应。结果:七十三名患者接受了治疗。所有已收到至少一个前淋巴瘤治疗; 40% were rituximab naive. Infusions were delivered in an outpatient setting and were well tolerated. The most common study-related adverse events (AE) were lymphopenia, leukopenia, neutropenia, fatigue, and chills. The overall response rate at the recommended phase II dose of galiximab (500 mg/m(2)) was 66%: 19% complete response, 14% unconfirmed complete response, and 33% partial response. The median progression free survival was 12.1 months. Combination therapy did not appear to alter pharmacokinetics. CONCLUSION: These results indicate that galiximab can be safely combined with a standard course of rituximab. This doublet biologic approach offers the potential to avoid or delay chemotherapy or to integrate with other lymphoma therapies. A phase III, randomized study evaluating clinical benefit of rituximab versus the combination has been initiated.

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药物
药物靶点
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
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