A Non-Interventional, Observational Phase IV Study to Evaluate Safety of Rituximab (Mabthera®) in Combination With Chemotherapy in Patients Treated With CD20+ Β Chronic Lymphocytic Leukemia
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 67
- 试验地点
- 9
- 主要终点
- Percentage of Participants With Adverse Events (AEs)
研究概览
简要总结
This observational study will evaluate the safety and efficacy of rituximab in combination with chemotherapy in first- and second-line treatment of participants with cluster of differentiation 20 (CD20)-positive B-cell chronic lymphocytic leukemia. Data will be collected from eligible participants receiving rituximab according to the Summary of Product Characteristics (SPC) during 6 months of treatment.
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
- •Participants with CD20-positive B-cell chronic lymphocytic leukemia eligible for first-line or second-line therapy according to the approved SPC
排除标准
- •Contraindications to rituximab therapy according to the approved SPC
研究组 & 干预措施
Rituximab
Participants with chronic lymphocytic leukemia treated with rituximab in combination with chemotherapy according to SPC and routine clinical practice will be observed for 24 months.
干预措施: Rituximab (Drug)
结局指标
主要结局
Percentage of Participants With Adverse Events (AEs)
时间窗: Baseline up to 24 months
An AE was defined as any untoward medical occurrence in a participant who received study drug without regard to possibility of causal relationship.
次要结局
- Percentage of Participants With Objective Response of Complete Response (CR) or Partial Response (PR) Assessed Using Local Standards(Months 6, 12, 18, and 24)
- Percentage of Participants With CR Assessed Using Local Standards(Months 6, 12, 18, and 24)
- Progression-Free Survival (PFS) Assessed Using Local Standards(From enrollment until disease progression or death, assessed up to 24 months)
- Percentage of Participants With Disease Progression or Death Assessed Using Local Standards(Months 6, 12, 18, and 24)
- Percentage of Participants With PR Assessed Using Local Standards(Months 6, 12, 18, and 24)
- Time to Progression (TTP) Assessed Using Local Standards(From enrollment until disease progression or death, assessed up to 26 months)