IDEC Y2B8 VS RITUXAN IN REFRACTORY LOW GRADE OR FOLLICULAR B CELL NON HODGKINS

IDEC Y2B8 与 RITUXAN 在难治性低级别或滤泡 B 细胞非霍奇金淋巴瘤中的比较

• 批准号: 6263459
• 负责人: MANSOOR N SALEH
• 金额: $ 2.95万
• 依托单位: UNIVERSITY OF ALABAMA AT BIRMINGHAM
• 依托单位国家: 美国
• 财政年份: 1998
• 资助国家: 美国
• 起止时间: 1998-12-01 至 1999-11-30
• 项目状态: 已结题
• 来源: https://reporter.nih.gov/project-details/6263459
• 关键词: antibody; antineoplastics; clinical research; human subject; human therapy evaluation; neoplasm /cancer chemotherapy; neoplasm /cancer immunotherapy; neoplasm /cancer relapse /recurrence; nonHodgkin's lymphoma; radiotracer

This is a pivotal, randomized phase III clinical trial comparing the radiolabeled Y2B8 with the unlabeled C2B8 antibody in relapsed or refractory low-grade lymphoma. The unlabeled agent has a reponse rate of 30% with approximately 5% complete remissions in phase II settings as compared to 70% and 40%, respectively, for the phase II study of Y2B8. The current pivotal multi-institutional trial will address the issue of the superiority of one or the other reagent. It should be noted that there is a cross-over arm whereby patients receiving the unlabeled antibody can receive the radiolabeled antibody.

这是一项关键的随机 III 期临床试验，比较了放射性标记的 Y2B8 与未标记的 C2B8 抗体在复发或难治性低度淋巴瘤中的作用。 未标记的药物在 II 期研究中的缓解率为 30%，完全缓解率约为 5%，而 Y2B8 II 期研究的缓解率分别为 70% 和 40%。 当前的关键多机构试验将解决一种或另一种试剂的优越性问题。 应当指出的是，存在交叉臂，接受未标记抗体的患者可以接受放射性标记抗体。