Acalabrutinib Real World Italian obSErvational Secondary Data Collection Study of Acalabrutinib in the Treatment of Patients With Chronic Lymphocytic Leukemia.
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
- 151
- 试验地点
- 42
- 主要终点
- time to acalabrutinib discontinuation
研究概览
简要总结
Chronic lymphocytic leukemia (CLL) is the most common form of leukemia in the adults in the Western world, with an annual incidence of approximately 5 cases per 100,000 inhabitants in Italy.
Acalabrutinib (CalquenceTM), a selective second-generation Bruton Tyrosine Kinase (BTK) inhibitor developed by AstraZeneca, has been assessed for the treatment of CLL in three phase III clinical trials, ELEVATE-TN (treatment-naïve CLL), ASCEND and ELEVATE R/R (relapsed and refractory CLL). These pivotal randomized clinical trials established the efficacy and safety of acalabrutinib in patients with CLL and based on these data CalquenceTM received EMA approval in November 2020 for the treatment of CLL in adult patients and received AIFA (Agenzia Italiana del Farmaco) reimbursement as monotherapy in December 2021. However, further data are still required to evaluate the use of acalabrutinib in the real-life conditions of post-marketing authorization.
The primary aim of ARISE study is to evaluate the time to treatment discontinuation and reasons for discontinuation for acalabrutinib in a real world setting of patients with CLL. This study will provide the first real-world data on the use of acalabrutinib in the treatment of CLL in Italy.
详细描述
Study design:
This is an Italian non-interventional / observational, multicenter, longitudinal secondary data usage study based on a retrospective cohort of patients with CLL, who initiated treatment with acalabrutinib between 1st May 2021 and 30th April 2022 (index date), regardless of the treatment status at the time of inclusion. Each patient will be followed-up up to 5 years since the last enrolled patient index date (therefore for a maximum of 72 months). Five data extraction timepoints are planned for the investigators to proceed with secondary data extraction from patients' medical records and data entry into the electronic case report form (eCRFs).
Data Source(s):
Source documents (paper or electronic) are those in which patient data are recorded and documented for the first time as part of patients' path of care (e.g., patient's hospital records, pharmacy dispensing records).
A standardized, validated eCRF will be developed to capture data extracted from source documents at each participating site.
研究设计
- 研究类型
- Observational
- 观察模型
- Other
- 时间视角
- Retrospective
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
- •All consecutive patients with CLL who received acalabrutinib according to Italian legislation dlg 219/2006 art.125 will be eligible for inclusion in the study, subject to site agreement and patient consent to participate.
- •Patients must meet the following criteria for study entry:
- •Age ≥ 18 years old at the date of consent subscription.
- •Diagnosis of CLL.
- •Treatment of CLL with acalabrutinib at physician's discretion initiated between 1st May 2021 and 30th April
- •Informed consent to participate in the study and privacy form signed by the patient (or their legal representative).
排除标准
- •Patients who meet any of the following criteria will be excluded:
- •1. Acalabrutinib treatment initiation before 1st May 2021 or after 30th April 2022.
结局指标
主要结局
time to acalabrutinib discontinuation
时间窗: through study completion, an average of 5 years
The primary outcome is the time to acalabrutinib discontinuation (defined as time in days from start date of acalabrutinib treatment to end date of acalabrutinib treatment) Kaplan-Meier median time to acalabrutinib discontinuation (defined as time in days from start date of acalabrutinib treatment to end date of acalabrutinib treatment). (Note: Any acalabrutinib treatment suspension \>28 days is defined as discontinuation. Any acalabrutinib treatment suspension ≤ 28 days is defined as interruption and should not be considered for the analysis of the primary objective.
次要结局
- demographic and clinical characteristics of CLL patients treated with acalabrutinib(baseline)
- FISH profile(baseline)
- differential count of lymphocytes and neutrophils(Through study completion, an average of 5 years)
- Height(baseline)
- Weight(throught study completion, an average of 5 years)
- Body Mass Index(Through study completion, an average of 5 years)
- describe acalabrutinib treatment patterns(through study completion, an average of 5 years)
- CLL clinical stage(baseline)
- Date of birth(baseline)
- Red blood cell count(Through study completion, an average of 5 years)
- gender(baseline)
- Medical illness burden(Through study completion, an average of 5 years)
- White blood cell count(Through study completion, an average of 5 years)
- platelets count(Through study completion, an average of 5 years)
- hemoglobin(Through study completion, an average of 5 years)
- creatinine clearance (mL/min), aspartate transaminase (AST; U/L), alanine transaminase (ALT; U/L), gamma-glutamyl transferase (GGT; U/L), bilirubin (mg/dL), LDH (U/L), β2-microglobulin (mg/dL), IgG, IgA, IgM levels (mg/dL)(baseline)
- Anti-HIV antibodies test and Hepatitis serology tests including hepatitis B surface antigen (HbsAg), hepatitis B surface antibody (HbsAb), hepatitis B core antibody (anti-HBc), and hepatitis C (HCV) antibody(baseline)