Medical Events of Interest and Health-Related Quality of Life in Chronic Lymphocytic Leukemia Patients Initiating Treatment With Bruton's Tyrosine Kinase Inhibitors Acalabrutinib or Ibrutinib
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 发起方
- AstraZeneca
- 入组人数
- 23
- 试验地点
- 1
- 主要终点
- Chart Recorded Medical Events of Interest
研究概览
简要总结
This is a multi-site observational study of medical events of interest (MEOI) and health-related quality of life (HRQoL) in chronic lymphocytic leukemia (CLL) patients initiating treatment with the Bruton's tyrosine kinase inhibitors (BTKi) acalabrutinib or ibrutinib in the United States (US)
研究设计
- 研究类型
- Observational
- 观察模型
- Cohort
- 时间视角
- Prospective
入排标准
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •≥18 years old
- •Physician-confirmed diagnosis of CLL or small lymphocytic lymphoma (SLL)
- •BTKi naïve patients who initiate acalabrutinib or ibrutinib treatment alone or in combination with an anti-CD20 mAb within 7 days (before or after) study enrollment*. Both treatment naïve and relapsed/refractory CLL patients will be included.
- •Provides informed consent
- •Adequate English reading skills
- •Able to access and use a computer, tablet, or smartphone to complete PROs
排除标准
- •Use of BTKi any time prior to study enrollment.
- •Currently receiving systemic treatment for another malignancy
- •Currently enrolled in a clinical trial
结局指标
主要结局
Chart Recorded Medical Events of Interest
时间窗: 24 Month Follow-up
To describe MEOI experienced by CLL patients who have recently initiated acalabrutinib or ibrutinib using medical chart abstracted data, over a 24-month period
Patient Characteristics
时间窗: Baseline
To describe the demographic and clinical characteristics of CLL patients who have recently initiated acalabrutinib or ibrutinib.
HRQoL
时间窗: 24 month follow-up
To describe HRQoL for CLL patients who recently initiated acalabrutinib or ibrutinib using patient reported data, over a 24-month period
Patient Reported Medical Events of Interest
时间窗: 24 month follow-up
To describe MEOI experienced by CLL patients who have recently initiated acalabrutinib or ibrutinib using patient reported data, over a 24-month period.
次要结局
未报告次要终点