A Non-interventional, Prospective, Open-label, Observational Study Evaluating the Effectiveness and Safety of Acalabrutinib (Calquence®) in Patients With Chronic Lymphocytic Leukemia (CLL) Receiving Direct Oral Anticoagulation (DOAC).
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 发起方
- iOMEDICO AG
- 入组人数
- 45
- 试验地点
- 2
- 主要终点
- Incidence proportion of patients with major bleeding event according to Schulman et al.
研究概览
简要总结
The goal of CICERO is to investigate the clinical outcome with a particular focus on prospective data on safety using acalabrutinib (+/- obinutuzumab) in CLL patients receiving co-medication with DOACs (edoxaban, rivaroxaban, dabigatran, apixaban) irrespective of treatment line.
详细描述
The non-interventional study (NIS) CICERO will collect real-world data to explore acalabrutinib (+/- obinutuzumab) in adult CLL patients (irrespective of treatment line) who receive co-medication with DOACs. The primary focus of the study is to investigate the incidence proportion of bleeding events. Due to the mostly elderly CLL patient population, CLL patients often suffer from multiple cardiovascular comorbidities including atrial fibrillation (AF), deep vein thrombosis (DVT) or pulmonary embolism (PE) which make anticoagulation mandatory.
Up to now, no systematic and prospective evaluation on interactions of BTKis and DOACs has been conducted.
In Order to assess bleeding events, a questionnaire will be used to document if bleeding events occurred in-between visits in routine care. Patients will be asked at each visit if distinct events occurred in the time between the last visit until the current visit and discuss the questionnaire with the physician to determine of any (S)AE occurred until end of acalabrutinib treatment.
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
- •18 years of age or older
- •Patients with chronic lymphocytic leukemia (CLL) and decision for treatment with acalabrutinib (+/- obinutuzumab) according to current SmPC as assessed by the treating physician or already started treatment with acalabrutinib (+/- obinutuzumab) according to current SmPC no longer than 6 weeks ago
- •Other concomitant disease resulting in medical need of or already under treatment with direct oral anticoagulant (DOAC) treatment with edoxaban (Lixiana®) or rivaroxaban (Xarelto®) or dabigatran (Pradaxa®) or apixaban (Eliquis®) according to the respective current SmPC.
- •Eastern Cooperative Oncology Group (ECOG) performance status 0-2
- •Signed, written informed consent.
排除标准
- •Combination of acalabrutinib with other substances than obinutuzumab for CLL treatment
- •Participation in an interventional clinical trial with acalabrutinib
研究组 & 干预措施
first-line therapy
Patients enrolled for first-line acalabrutinib (+/- obinutuzumab).
干预措施: Calquence (Drug)
later-line therapy
Pre-treated patients enrolled for later-line acalabrutinib therapy.
干预措施: Calquence (Drug)
结局指标
主要结局
Incidence proportion of patients with major bleeding event according to Schulman et al.
时间窗: Baseline until end of acalabrutinib treatment (+ 30 days safety follow-up); up to 41 months
Bleeding event is defined as major according to Schulmann et al., if it is fatal (contributes to death) and/or symptomatic in a critical area or organ (such as intracranial, intraspinal, intraocular, retroperitoneal, intraarticular or pericardial, or intramuscular with compartment syndrome) and/or causing a decrease in hemoglobin of 2 g/dL (1.24 mmol/l) or more or requires a transfusion of 2 or more units of whole blood or red blood cells. Incidence proportion (cumulative incidence) is calculated as the number of patients with bleeding event while on treatment (+30 days safety follow-up), divided by the number of patients in the full analysis population.
次要结局
- Incidence proportion of clinically relevant non-major (CRNM) bleeding events(Baseline, up to 41 months)
- Major (according to Schulman et al.) and/or CRNM bleeding events.(Baseline, up to 41 months)
- Any bleeding event.(Baseline, up to 41 months)
- Incidence proportion of major bleeding according to Ghia et al.(Baseline, up to 41 months)
- Time to first Occurrence of major bleeding events(Baseline, up to 41 months)
- Incidence proportion of central nervous system (CNS) bleeding events(Baseline, up to 41 months)
- Patient safety regarding mortality(Baseline, up to 41 months)
- Patient safety in terms of interactions with effectiveness of DOAC(Baseline, up to 41 months)
- VTE (venous thromboembolism)-related death(Baseline, up to 41 months)
- Overall response rate (ORR)(Baseline, up to 41 months)
- Progression-free survival (PFS)(Baseline, up to 41 months)
- Overall survival (OS)(Baseline, up to 41 months)
- Therapy decision making(Baseline)
- Previous therapies(Baseline)
- Acalabrutinib (+/- obinutuzumab) treatment: Duration(Baseline, up to 41 months)
- Acalabrutinib (+/- obinutuzumab) treatment: Dose intensity(Baseline, up to 41 months)
- Obinutuzumab treatment: Duration(Baseline, up to 41 months)
- Reasons for end of treatment of obinutuzumab(Baseline, up to 41 months)
- Types of DOAC(Baseline, up to 41 months)
- Reasons for DOAC treatment(Baseline, up to 41 months)
- DOAC treatment: Duration(Baseline, up to 41 months)
- DOAC treatment: Dose modifications(Baseline, up to 41 months)
- DOAC treatment: Reasons for dose modifications(Baseline, up to 41 months)
- DOAC treatment: Reasons for end of treatment(Baseline, up to 41 months)
- Time from onset to DOAC to start of acalabrutinib(Baseline, up to 41 months)
- Concomitant medication(Baseline, up to 41 months)