NCT01224821已完成2 期
Multicenter, Phase II Dosimetry/Validation Study of 131Iodine-Anti B1 (Murine) Radioimmunotherapy for Chemotherapy Refractory Low Grade B Cell Lymphomas and Low Grade Lymphomas That Have Transformed to Higher Grade Histologies
适应症
试验速览
- 阶段
- 2 期
- 状态
- 已完成
- 入组人数
- 47
- 主要终点
- Number of Participants Who Received the Therapeutic Dose at the Seven Clinical Research Sites
研究概览
简要总结
Study RIT-II-001 is a phase II, multicenter study of the safety, tumor and organ dosimetry, dosimetry methods, and efficacy of Iodine-131 Anti-B1 Antibody for the treatment of patients with low-grade or transformed low-grade non-Hodgkin's lymphoma (NHL). The primary objective of this study is to demonstrate that each site could accurately conduct the whole body dosimetry required for the safe and effective dosing of Iodine-131 Anti-B1 Antibody. Additional objectives of this study are to evaluate the efficacy, dosimetry, and safety of Iodine-131 Anti-B1 Antibody.
研究设计
- 研究类型
- Interventional
- 分配方式
- Na
- 干预模型
- Single Group
- 主要目的
- Treatment
- 盲法
- None
入排标准
- 年龄范围
- 18 Years 至 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- 未提供
排除标准
- 未提供
结局指标
主要结局
Number of Participants Who Received the Therapeutic Dose at the Seven Clinical Research Sites
时间窗: Day 1 within one hour of infusion (I) and prior to urination (U); Days 2, 3, and 4 after dosimetric dose (DD) I, following U; Days 6 and 7 after DD I, following U
The dosimetry methods were validated for seven different clinical research sites.
次要结局
- Number of Participants With the Indicated Therapeutic Doses (TD) (Total Body Dose)(Participants were evaluated for up to 142 months in Study 104731 or were followed in the long-term follow-up study (Study 104526) for up to 136.3 months)
- Number of Participants With Confirmed Response (CR, CCR, or PR), as Assessed by the Investigator(Participants were evaluated for up to 142 months in Study 104731 or were followed in the long-term follow-up study (Study 104526) for up to 136.3 months)
- Number of Participants (Par.) With Response (CR, CCR, or PR), as Assessed by the Investigator(Participants were evaluated for up to 142 months in Study 104731 or were followed in the long-term follow-up study (Study 104526) for up to 136.3 months)
- Duration of Response for All Confirmed Responders (CR, CCR, or PR), as Assessed by the Investigator(Participants were evaluated for up to 142 months in Study 104731 or were followed in the long-term follow-up study (Study 104526) for up to 136.3 months)
- Duration of Response for All Confirmed Complete Responders, as Assessed by the Investigator(Participants were evaluated for up to 142 months in Study 104731 or were followed in the long-term follow-up study (Study 104526) for up to 136.3 months)
- Duration of Response for All Unconfirmed Complete Responders, as Assessed by the Investigator(Participants were evaluated for up to 142 months in Study 104731 or were followed in the long-term follow-up study (Study 104526) for up to 136.3 months)
- Duration of Response for All Unconfirmed Responders (CR, CCR, or PR), as Assessed by the Investigator(Participants were evaluated for up to 142 months in Study 104731 or were followed in the long-term follow-up study (Study 104526) for up to 136.3 months)
- Duration of Response for All Confirmed Clinical Complete Responders, as Assessed by the Investigator(Participants were evaluated for up to 142 months in Study 104731 or were followed in the long-term follow-up study (Study 104526) for up to 136.3 months)
- Time to Disease Progression or Death for Responders, as Assessed by the Investigator(Participants were evaluated for up to 142 months in Study 104731 or were followed in the long-term follow-up study (Study 104526) for up to 136.3 months)
- Time to Disease Progression or Death for All Participants, as Assessed by the Investigator(Participants were evaluated for up to 142 months in Study 104731 or were followed in the long-term follow-up study (Study 104526) for up to 136.3 months)
- Number of Participants With CR and CCR, as Assessed by the Investigator(Participants were evaluated for up to 142 months in Study 104731 or were followed in the long-term follow-up study (Study 104526) for up to 136.3 months)
- Number of Participants With Confirmed CR and CCR, as Assessed by the Investigator(Participants were evaluated for up to 142 months in Study 104731 or were followed in the long-term follow-up study (Study 104526) for up to 136.3 months)
- Duration of Response for All Unconfirmed Clinical Complete Responders, as Assessed by the Investigator(Participants were evaluated for up to 142 months in Study 104731 or were followed in the long-term follow-up study (Study 104526) for up to 136.3 months)
- Median Time to Treatment Failure for All Participants(Participants were evaluated for up to 142 months in Study 104731 or were followed in the long-term follow-up study (Study 104526) for up to 136.3 months)
- Overall Survival(Participants were evaluated for up to 142 months in Study 104731 or were followed in the long-term follow-up study (Study 104526) for up to 136.3 months)
研究者
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