IDEC Y2B8 RADIOIMMUNOTHERAPY COMPARED TO RITUXAN IN RELAPSED B CELL LYMPHOMA

IDEC Y2B8 放射免疫疗法与 Rituxan 治疗复发 B 细胞淋巴瘤的比较

• 批准号: 6304166
• 负责人: Leo I. Gordon
• 金额: $ 2.05万
• 依托单位: NORTHWESTERN UNIVERSITY AT CHICAGO
• 依托单位国家: 美国
• 财政年份: 1999
• 资助国家: 美国
• 起止时间: 1999-12-01 至 2000-11-30
• 项目状态: 已结题
• 来源: https://reporter.nih.gov/project-details/6304166
• 关键词: B cell lymphoma; antineoplastics; clinical research; combination cancer therapy; drug screening /evaluation; human subject; human therapy evaluation; monoclonal antibody; neoplasm /cancer immunotherapy; neoplasm /cancer radionuclide therapy; neoplasm /cancer relapse /recurrence; nonHodgkin's lymphoma; radiation therapy dosage; radionuclides; yttrium

This is a randomized, Phase III, multi-center, controlled study comparing the efficacy and safety of a single course of IDEC-Y2B8 with a course of Rituxan in patients with advanced, relapsed or refractory non-Hodgkin's B-cell lymphoma. A course of IDEC-Y2B8 includes an imaging dose of IDEC-In2B8 followed one week later by a single dose of IDEC-Y2B8; both IDEC-Y2B8 and IDEC-In2B8 are preceded by an infusion of 250 mg/m2 Rituxan. A course of Rituxan includes four infusions of 375 mg/m2 (once weekly x 4) of Rituxan. Patients with low-grade or follicular NHL who have relapsed disease or have failed primary conventional chemotherapy and now require treatment will be eligible for this study. Patients meeting the study inclusion and exclusion criteria may be enrolled into the study.

这是一项比较IDEC-Y2 B8单疗程与Rituxan单疗程治疗晚期、复发性或难治性非霍奇金B细胞淋巴瘤患者的疗效和安全性的随机、III期、多中心、对照研究。 IDEC-Y2 B8的疗程包括IDEC-In 2B 8成像剂量，一周后进行IDEC-Y2 B8单次给药; IDEC-Y2 B8和IDEC-In 2B 8之前均输注250 mg/m2 Rituxan。 Rituxan的一个疗程包括四次输注375 mg/m2（每周一次x4）Rituxan。 患有复发性疾病或原发性常规化疗失败且现在需要治疗的低度或滤泡性NHL患者将有资格参加本研究。 符合研究入选和排除标准的患者可入组研究。