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IDEC Y2B8 RADIOIMMUNOTHERAPY COMPARED TO RITUXAN IN RELAPSED B CELL LYMPHOMA

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
依托单位国家:
美国
项目类别:
财政年份:
1999
资助国家:
美国
项目状态:
已结题
起止时间:
1999-12-01 至 2000-11-30

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中文摘要
翻译
这是一项随机、第三阶段、多中心的对照研究,比较了IDEC-Y2B8单疗程和Rituxan一个疗程对晚期、复发或难治性非霍奇金B细胞淋巴瘤患者的疗效和安全性。IDEC-Y2B8的疗程包括IDEC-IN2B8的显像剂剂量,一周后单剂IDEC-Y2B8;IDEC-Y2B8和IDEC-IN2B8在IDEC-Y2B8和IDEC-IN2B8的疗程之前都先输注250 mg/m2的Rituxan。Rituxan一个疗程包括四次输注375 mg/m2的Rituxan(每周一次,共4次)。患有低度恶性或滤泡性非霍奇金淋巴瘤的患者,如果病情复发或常规化疗失败,现在需要治疗,将有资格参加这项研究。符合研究纳入和排除标准的患者可被纳入研究。
英文摘要
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.
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IDEC Y2B8 RADIOIMMUNOTHERAPY IN B CELL NON HODGKINS LYMPHOMA
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IDEC 10603--IDEC Y2B8 ADMINISTERED TO PATIENTS WITH B CELL LYMPHOMA
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