Observational, Secondary Data Collection Study to Describe Acalabrutinib Treatment Outcomes in Chronic Lymphocytic Leukemia Patients in Real-life Setting in Romania
试验速览
- 阶段
- 不适用
- 状态
- 进行中（未招募）
- 发起方
- AstraZeneca
- 入组人数
- 250
- 试验地点
- 19
- 主要终点
- Time to acalabrutinib treatment discontinuation (TTD)
研究概览
简要总结
Acalabrutinib received European Medicines Agency approval on November 2020 for for CLL adult patients, either as monotherapy or in combination with obinutuzumab, in previously untreated patients or as monotherapy in patients who have received at least one prior therapy and is reimbursed in Romania since January 2023. In the absence of disease registries or national datasets patient population receiving acalabrutinib in real life setting is not well characterized. The study aims to look into this population outcomes and clinical characteristics having as primary objective time to discontinuation by line of treatment and secondary objectives: reasons for discontinuation, effectiveness of acalabrutinib in real-life practice, baseline clinical and demographic characteristics, treatment patterns and major determinants of treatment discontinuation. The study will retrospectively collect longitudinal data from 250 patients at national level,at pre-defined timepoints for 3 years, from 2 sequential cohorts,1st one enrolled on December 2023 and 2nd one enrolled in December 2024 based on the acalabrutinib start year..
研究设计
- 研究类型
- Observational
- 观察模型
- Cohort
- 时间视角
- Retrospective
入排标准
- 年龄范围
- 18 Years 至 130 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Adult patients (age >18 years) with confirmed diagnosis of chronic lymphocytic leukemia/ small lymphocytic lymphoma
- •Patients initiating front-line or subsequent treatment with acalabrutinib between January 2023 and Dec 2024 according to the national therapeutic protocol
- •Patients able and willing to provide their written informed consent to participate in the study
排除标准
- •The treatment with acalabrutinib was initiated during an interventional clinical trial
- •Enrolment performed less than 30 days from start of treatment with acalabrutinib
研究组 & 干预措施
Cohort 1
December 2023 - collecting data retrospectively from patients routinely initiated on acalabrutinib between January - December 2023
干预措施: Non interventional study (Drug)
Cohort 2
December 2024-collecting data retrospectively from patients routinely initated on acalabrutinib between January - December 2024
干预措施: Non interventional study (Drug)
结局指标
主要结局
Time to acalabrutinib treatment discontinuation (TTD)
时间窗: Once a year during the 3 years of follow up since acalabrutinib start
TTD is defined as the time between the first day of acalabrutinib treatment and the day that acalabrutinib is definitely stopped for whatever reason or death
次要结局
- effectiveness of acalabrutinib(Once a year until end of the study ( 3 years from start of acalabrutinib))
- Reasons of acalabrutinib dose changes(once a year until the end of the study ( 3 years from acalabrutinib start))
- Major determinant of treatment discontinuation(once a year until end of the study( 3 years from acalabrutinib start))
- Reasons for treatment discontinuation(Once a year until end of the study ( 3 years from start of acalabrutinib))
- duration of interruption(once a year until the end of the study ( 3 years from acalabrutinib start))
- Baseline clinical and demographic characteristics(At first data collection for cohort 1 in December 2023 and at first data collection for cohort 2 in December 2024)
- time to interruption(Once a year until end of the study ( 3 years from start of acalabrutinib))
- acalabrutinib dose changes(once a year until the end of the study ( 3 years from acalabrutinib start))
- acalabrutinib interruption(Once a year until end of the study (3 years from the start of acalabrutinib))