IDEC Y2B8 RADIOIMMUNOTHERAPY FOR NON HODGKINS LYMPHOMA AFTER RITUXIMAB

利妥昔单抗治疗后的 IDEC Y2B8 放射免疫治疗非霍奇金淋巴瘤

• 批准号: 6263971
• 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: 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/6263971
• 关键词: B cell lymphoma; antineoplastics; clinical research; combination cancer therapy; human subject; human therapy evaluation; hybrid antibody; immunoglobulin G; monoclonal antibody; neoplasm /cancer immunotherapy; neoplasm /cancer radionuclide therapy; yttrium

Yttrium-labeled IDEC anti-CD20 murine monoclonal antibody (IDEC- Y2B8) in combination wtih the chimeric IgG1 kappa anti-CD20 monoclonal antibody Rituxan is under investigation for treatment of patients with relapsed or refractory B-cell non-Hodgkin's lymphoma (NHL). The objectives of this trial are: 1) to determine the efficacy of IDEC- Y2B8 therapy in patients with relapsed or refractory, low grade or follicular or transformed B-cell non-Hodgkin's lymphoma whose disease did not respond (did not achieve a Pr or CR) to previous treatment with Rituxan. The primary efficacy variable will be overall response rate, secondary efficacy variables wil lbe duration of response and time to progression, and additional analyses will include complete, clinical complete and partial response rate, and time to next anti-cancer treatment and 2) to characterize (qualitative, quantitative, duration and reversibility) the safety (adverse events) of both IDEC-Y2B8 as a therapeutic agent and IDEC-In2B8 as an imaging agent when administered in conjunction with Rituxan.

钇标记的IDEC抗CD 20鼠单克隆抗体（IDEC-Y2 B8）与嵌合IgG 1 κ抗CD 20单克隆抗体Rituxan联合治疗复发性或难治性B细胞非霍奇金淋巴瘤（NHL）患者的研究正在进行中。本试验的目的是：1）确定IDEC-Y2 B8治疗对既往Rituxan治疗无应答（未达到Pr或CR）的复发性或难治性、低度或滤泡性或转化型B细胞非霍奇金淋巴瘤患者的疗效。 主要疗效变量将是总体缓解率，次要疗效变量将是缓解持续时间和至进展时间，额外分析将包括完全缓解率、临床完全缓解率和部分缓解率，以及至下一次抗癌治疗的时间，以及2）表征（定性、定量、持续时间和可逆性）与Rituxan联合给药时，IDEC-Y2 B8作为治疗剂和IDEC-In 2B 8作为显像剂的不良事件。