NCT01072240已完成不适用
An Observational Registration Study of Infusion-related Adverse Events at Administration of Mabthera (Rituximab) in the Treatment of Chronic Lymphocytic Leukemia.
适应症
干预措施
相关药物
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 92
- 主要终点
- infusion-related adverse events
研究概览
简要总结
This observational study will monitor and register infusion-related adverse events and their handling in patients with chronic lymphocytic leukemia on treatment with MabThera (rituximab). Data will be collected from patients receiving intravenous MabThera at a dose of 375mg/m2 in cycle 1 and 500mg/m2 in subsequent cycles at each treatment visit for up to 6 months. Target sample size is 100 patients.
研究设计
- 研究类型
- Observational
- 观察模型
- Cohort
- 时间视角
- Prospective
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
- •adult patients, >/= 18 years of age
- •chronic lymphocytic leukemia treated with rituximab (MabThera)
- •rituximab (MabThera) dosage 375 mg/m2 in cycle 1, 500 mg/m2 in subsequent cycles
- •informed consent to data collection
排除标准
- •participation in an interventional clinical study
研究组 & 干预措施
Cohort
干预措施: rituximab [Mabthera/Rituxan] (Drug)
结局指标
主要结局
infusion-related adverse events
时间窗: data collection every 4-6 weeks for up to 6 months for each patient
次要结局
- usage and applicability of 90-minute iv infusion in patients with CLL(data collection every 4-6 weeks for up to 6 months for each patient)
研究者
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