An Observational Study to Evaluate the Clinical and Biologic Features and Outcome of Patients With Relapsed or Refractory Chronic Lymphocytic Leukemia (CLL) Treated With Venetoclax-based Regimens Outside Clinical Trials in Italy
试验速览
- 阶段
- 不适用
- 状态
- 进行中（未招募）
- 入组人数
- 321
- 试验地点
- 54
- 主要终点
- Estimation of the PFS in relapsed/refractory (R/R) patients with CLL treated with venetoclax-based regimens according to the local label outside clinical trials in Italy.
研究概览
简要总结
Observational study aimed at describing the characteristics and outcome of CLL patients who started treatment with venetoclax-based regimens according to the local label outside clinical trials in Italy in a period of time ranging from the start of the Venetoclax Named Patient Program (March 2016) until June 30th, 2025.
详细描述
Observational study to describe the characteristics and outcome of CLL patients treated with venetoclax according to the local label. The study includes two different groups: a retrospective group (all patients who have received at least one dose of venetoclax before enrolment) and a prospective group (patients receiving treatment with venetoclax after enrolment). All patients in both groups will be observed for up to 48 months from the treatment start. In the prospective cohort only, QoL and treatment adherence will be assessed at the time of study entry (i.e. baseline) and thereafter at 3, 6, 9, 12, 18 24, 30, 36, 42 and 48 months of follow-up and at treatment discontinuation (due to any cause).
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
- •Patients with R/R CLL fulfilling the eligibility criteria required by the Venetoclax Named Patient Program who have received at least 1 dose of venetoclax.
- •Patients with CLL who have received at least 1 dose of venetoclax or are scheduled to start treatment with venetoclax according to the Post-marketing Use before June 30th,
- •Signed informed consent document (if feasible) according to ICH/EU/GCP and national local laws indicating that the patients understand the purpose of the study and they agree to give complete access to their medical records.
排除标准
- 未提供
研究组 & 干预措施
cohort group
Patients who have received at least one dose of venetoclax
干预措施: Venetoclax (Drug)
结局指标
主要结局
Estimation of the PFS in relapsed/refractory (R/R) patients with CLL treated with venetoclax-based regimens according to the local label outside clinical trials in Italy.
时间窗: 15 months
Estimation of the PFS at 15 months from the start of venetoclax treatment in patients with R/R CLL who started treatment with venetoclax-based regimens according to the local label from the start of the Venetoclax Named Patient Program (March 2016) until October 31st, 2021
次要结局
未报告次要终点