NCT01224093已完成不适用
A Multicentre, Observational, Prospective Study to Assess the Safety Profile of Rituximab in Combination With Chemotherapy in Patients With B Cell-lineage Chronic Lymphocytic Leukaemia (B-CLL)
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
- 219
- 主要终点
- Safety profile of MabThera/Rituxan in combination with chemotherapy in unselected CLL patients
研究概览
简要总结
This prospective observational study will evaluate the safety of MabThera/Rituxan (rituximab) in combination with chemotherapy in patients with previously untreated or relapsed/refractory B cell-lineage chronic lymphocytic leukaemia. Data will be collected from each patient for 6-12 months, depending on the prescribed chemotherapy regimen.
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
- •B cell-lineage chronic lymphocytic leukaemia (B-CLL)
- •Prescribed with MabThera/Rituxan in combination with chemotherapy according to the approved SMPC
- •Informed consent to data collection
排除标准
- •Treatment with any marketed or non-marketed drug substance or experimental therapy within 4 weeks prior to first dose of study drug or participation in a clinical trial within 30 days prior to entering this study
- •Any other tumour disease
研究组 & 干预措施
First line
干预措施: Chemotherapy (Drug)
First line
干预措施: rituximab [MabThera/Rituxan] (Drug)
Relapsed/refractory
干预措施: Chemotherapy (Drug)
Relapsed/refractory
干预措施: rituximab [MabThera/Rituxan] (Drug)
结局指标
主要结局
Safety profile of MabThera/Rituxan in combination with chemotherapy in unselected CLL patients
时间窗: 3 years
次要结局
- Efficacy (Response rate, duration of response, progression-free survival)(3 years)
- Chronic lymphocytic leukaemia (CLL) Comorboid Scale(3 years)
- Quality-adjusted survival analysis (Q-TWIST methodology)(3 years)
研究者
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