Retention Rate of Acalabrutinib in a Non-interventional Setting
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
- 137
- 试验地点
- 1
- 主要终点
- Retention rate of CLL
研究概览
简要总结
Retention rate of acalabrutinib in a non-interventional setting. This is a prospective, multicentre, non-interventional study to collect real-world data on retention rates of CLL patients prescribed with acalabrutinib in Germany.
详细描述
This observational study will prospectively assess acalabrutinib therapy retention of CLL patients one year and 2 years after treatment initiation with acalabrutinib in routine clinical practice. Furthermore, therapy adherence, treatment efficacy, overall survival, and QoL to analyse the possible influence of psychological aspects of the patient-based disease perception, a four-group-segmentation for acceptance and perceived control of the health state will be conducted. Finally, disease-, treatment-, and patient-specific factors possibly affecting therapy retention will be analysed: sociodemographic factors, disease and treatment characteristics, comorbidities, therapy adherence, treatment effectiveness, safety, QoL, and psychological segmentation.
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 99 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Age ≥ 18 years
- •Diagnosis of CLL
- •Ability to understand the study concept and to regularly complete patient questionnaires from physical, mental, and linguistic perspectives
- •Decision to start therapy with acalabrutinib according to the current SmPC. For previously untreated patients as continuous therapy with or without obinutuzumab. OR For patients with at least one prior CLL therapy as continuous monotherapy.
- •Provision of signed informed consent form
排除标准
- •Current or planned participation in an interventional clinical trial
- •Contraindications to treatment with acalabrutinib according to the current SmPC
- •Pregnancy or breast feeding
- •Disease progression on prior BTKi therapy
- •Start of acalabrutinib therapy more than 28 days prior to enrolment
结局指标
主要结局
Retention rate of CLL
时间窗: 1 year
The primary outcome of this study is the retention rate of CLL patients receiving acalabrutinib in clinical practice after 1 year (= ratio of the number of patients still being prescribed acalabrutinib after 1 year to the number of patients at risk). Cases of death, ongoing treatment interruption, and lost to follow-up will be counted as patients not still being prescribed with acalabrutinib.
次要结局
- Retention rate of CLL(2 years)
- General treatment adherence(assessed at baseline and 6, 12, and 24 months after start of acalabrutinib treatment)
- reasons for and duration of therapy interruptions(time from first prescription until therapy interruptions; assessed up to 40 months)
- TTD(time from start of acalabrutinib treatment until the date of final discontinuation or death; assessed up to 40 months.)
- TTNT(time from start of acalabrutinib treatment until start of a subsequent CLL treatment; assessed up to 40 months.)
- TTNT-D(time from start of acalabrutinib treatment until start of a subsequent CLL treatment or death; assessed up to 40 months)
- Treatment efficacy and PFS(time from start of acalabrutinib treatment until disease progression or death by any cause, whichever occurs first; assessed up to 40 months.)
- Overall survival(time from start of acalabrutinib treatment until death by any cause; assessed up to 40 months.)
- Patient- and disease-specific factors possibly affecting the retention rate(up to 40 months)
- Healths-related Quality of Life (HRQoL)-QLQ-C30(Patient questionnaires will becollected at time points synchronised with regular visits during study, assessed up to 40 months)
- Healths-related Quality of Life (HRQoL)-EQ-5D-5L(Patient questionnaires will becollected at time points synchronised with regular visits during study, assessed up to 40 months)
- Patient- and disease-specific factors possibly affecting the retention rate (Psychological patient segmentation)(at Baseline)