Drug Use Investigation of Zevalin
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 400
- 主要终点
- Incidence of serious adverse events, especially secondary malignant tumors, in subjects who received Zevalin
研究概览
简要总结
This study is a regulatory post marketing surveillance in Japan, and it is a local prospective and observational study of patients who have received Zevalin for relapsed or refractory, CD20+, low grade B-cell non-Hodgkin's lymphoma and Mantle cell lymphoma. The objective of this study is to assess safety and efficacy of using Zevalin in clinical practice. This study is also all case investigation of which the enrollment period is five years, and all patients who received Zevalin will be recruited and followed 13 weeks after the administration.
研究设计
- 研究类型
- Observational
- 观察模型
- Case Only
- 时间视角
- Prospective
入排标准
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Patients who received Zevalin for relapsed or refractory:
- •low grade B-cell non-Hodgkin's lymphoma
- •Mantle cell lymphoma
排除标准
- •Patients who are contraindicated based on the product label
研究组 & 干预措施
Group 1
干预措施: [90]Y-ibritumomab tiuxetan (Zevalin, BAY86-5128) (Drug)
结局指标
主要结局
Incidence of serious adverse events, especially secondary malignant tumors, in subjects who received Zevalin
时间窗: After In-111 Zevalin administration, up to 8 years
Incidence of adverse drug reactions in subjects who received Zevalin
时间窗: After In-111 Zevalin administration, up to 13 weeks
次要结局
- Effectiveness evaluation assessment [complete remission rate, complete remission uncertain rate, partial remission rate, stable disease rate, progression disease rate] by investigator-determined overall best response(After In-111 Zevalin administration, up to 13 weeks)
- Incidence of adverse drug reactions in subpopulation in a variety of baseline data [such as demographic data, medical history data, clinical staging](After In-111 Zevalin administration, up to 13 weeks)
- Effectiveness evaluation assessment [progression free survival] by investigator-determined overall best response(After In-111 Zevalin administration, up to 8 years)
- Change in neutrophil from baseline(After In-111 Zevalin administration, up to 13 weeks)
- Change in hemoglobin from baseline(After In-111 Zevalin administration, up to 13 weeks)
- Change in platelet from baseline(After In-111 Zevalin administration, up to 13 weeks)
- Change in leukocyte from baseline(After In-111 Zevalin administration, up to 13 weeks)