NCT02461316已完成不适用
Open, Non-Interventional, Multicentre Trial of Rituximab in Combination With FC for the First-Line Therapy of Patients With Chronic Lymphocytic Leukaemia
适应症
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 22
- 主要终点
- Percentage of Adverse Events (AEs)
研究概览
简要总结
Evaluation of safety profile and tolerability of MabThera (rituximab) in combination with chemotherapy (fludarabine and cyclophosphamide) in the treatment of Chronic Lymphocytic Leukemia (CLL).
研究设计
- 研究类型
- Observational
- 观察模型
- Case Only
- 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
- •Patients older than 18 years with diagnosed Chronic Lymphocytic Leukemia (CLL)
- •CLL stages: Binet stage C (Rai III or IV), Binet stage B (Rai I and II) requiring treatment
排除标准
- •Patients who are not eligible for rituximab treatment according to Summary of Product Characteristics (SmPC)
结局指标
主要结局
Percentage of Adverse Events (AEs)
时间窗: From baseline to end of study up to 18 months
Percentage of Serious Adverse Events (SAEs)
时间窗: From baseline to end of study up to 18 months
次要结局
未报告次要终点
研究者
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