I 131 ANTI B1 ANTIBODY IN NON HODGKINS LYMPHOMA VS UNLABELED ANTI B1

非霍奇金淋巴瘤中的 I 131 抗 B1 抗体与未标记抗 B1 抗体

• 批准号: 6263678
• 负责人: MARK S. KAMINSKI
• 金额: $ 0.02万
• 依托单位: UNIVERSITY OF MICHIGAN AT ANN ARBOR
• 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/6263678
• 关键词: antiantibody; clinical research; human subject; human therapy evaluation; iodine; longitudinal human study; neoplasm /cancer immunotherapy; neoplasm /cancer radionuclide therapy; nonHodgkin's lymphoma

This is a randomized, two-arm, open-label, multicenter, study comparing the safety and efficacy of Iodine-131 Anti-B1 Antibody to unlabeled Anti-B1 Antibody for the treatment of chemotherapy-refractory low-grade B-cell non-Hodgkin's lymphoma (NHL). Seventy-eight patients will be randomized to receive iodine-131 Anti-B1 Antibody (Arm A) or unlabeled Anti-B1 Antibody (Arm B). Patients randomized to receive unlabeled Anti-B1 Antibody may crossover and receive radiolabeled Iodine-131 Anti-B1 Antibody following progression of their lymphoma. Response in both arms will be assessed at 6 weeks, 3 months, and then at 3-monthly intervals for two years.

这是一项比较碘-131抗B1抗体与未标记抗B1抗体治疗化疗难治性低级别B细胞非霍奇金淋巴瘤（NHL）的安全性和疗效的随机化、两组、开放标签、多中心研究。 78例患者将随机接受碘-131抗B1抗体（A组）或未标记抗B1抗体（B组）。 随机接受未标记抗B1抗体治疗的患者可在淋巴瘤进展后交叉接受放射性标记碘-131抗B1抗体治疗。 将在6周、3个月以及随后每3个月一次评估两组的缓解情况，持续两年。