Observational Study of the Use of Venetoclax in Patients With Chronic Lymphocytic Leukemia (CLL) Under Real-Life Setting in Austria, Germany and Switzerland
试验速览
- 阶段
- 不适用
- 状态
- 招募中
- 发起方
- 入组人数
- 500
- 试验地点
- 168
- 主要终点
- Percentage of Participants Achieving Best Overall Response Rate (ORR)
研究概览
简要总结
An observational study to assess the effectiveness, health economic-relevant costs and participant reported outcomes in participants with Chronic lymphocytic leukemia (CLL) receiving venetoclax as a monotherapy or in combination with rituximab, obinutuzumab, ibrutinib, or acalabrutinib as prescribed at the discretion of the physician and in accordance with local clinical practice and label.
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
- •- Participant with chronic lymphocytic leukemia (CLL) who start venetoclax therapy can be included in the study if treated as specified in the local label for any specific line of treatment.
排除标准
- 未提供
研究组 & 干预措施
Participants Receiving Venetoclax + Ibrutinib
Participants with CLL receiving venetoclax in combination with ibrutinib.
Participants Receiving Venetoclax + Acalabrutinib
Participants with CLL receiving venetoclax in combination with acalabrutinib.
Participants Receiving Venetoclax
Participants with Chronic Lymphocytic Leukemia (CLL) receiving venetoclax.
Participants Receiving Venetoclax + Rituximab
Participants with CLL receiving venetoclax in combination with rituximab.
Participants Receiving Venetoclax + Obinutuzumab
Participants with CLL receiving venetoclax in combination with obinutuzumab.
结局指标
主要结局
Percentage of Participants Achieving Best Overall Response Rate (ORR)
时间窗: Up to 12 months
ORR is defined as the percentage of participants achieving partial response (PR) and complete response with incomplete regeneration of bone marrow (CRi) and complete response (CR) according to physician's assessment to therapy with venetoclax.
次要结局
未报告次要终点