National Acalabrutinib Observational Study

Study Overview
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Brief Summary
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The efficacy and safety of acalabrutinib in the treatment of patients with chronic lymphocytic leukemia (CLL) have been well established through 3 phase III clinical trials (ELEVATE TN, ASCEND, ELEVATE R/R) that led to European Medicines Agency approval in November 2020. The aim of this French longitudinal, non-interventional/observational, multicenter study is to describe the efficacy and safety of acalabrutinib treatment for CLL patients in real life. The primary objective is then to estimate the time to discontinuation of acalabrutinib therapy and the reasons for discontinuation, overall and by treatment line. The secondary objectives are to describe the baseline clinical and demographic characteristics of patients with CLL treated with acalabrutinib, to assess the efficacy of acalabrutinib through progression-free survival, overall survival, time to next treatment or death, describe acalabrutinib treatment patterns in CLL patients and reasons, identify key determinants of acalabrutinib discontinuation in CLL patients, estimate healthcare resource utilization. The overall response rate will be estimated as an exploratory objective. Patients included in this study will be CLL patients treated with acalabrutinib at the discretion of their physician between January 1, 2021 and December 31, 2022, who have been informed of the study and do not object to electronic processing of their data for research purposes (or do not object during their lifetime in the event of the patient's death prior to study initiation). Secondary data will be extracted from the hospital's patient records once a year. The protocol calls for the recruitment of 350 patients at 70 centres with a 3-year follow-up. Interim analyses will be performed annually until the end of the study.

Official Title
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A French Multicentric Observational Study of Acalabrutinib in the Treatment of Chronic Lymphocytic Leukemia Patients

Conditions
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Chronic Lymphocytic Leukemia

Intervention / Treatment
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* Drug: Non interventional study


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: Male or female patients aged ≥ 18 years old, CLL patients initiated with acalabrutinib at their physician's discretion between January 1st 2021 and December 31st 2022, Patients alive at study initiation and who have been informed verbally and/or in writing about this study, and who do not object to their data being electronically processed or subjected to data quality control (certified by physician); or patient who died before study initiation and who did not object to data collection for research purpose(s) during his or her lifetime. Exclusion Criteria: Patients participating in a clinical trial with an investigational drug within 30 days prior to acalabrutinib initiation, Patients who initiated acalabrutinib treatment before January 1st 2021.

Ages Eligible for Study
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Minimum Age: 18 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| CLL patients treated with acalabrutinib at their physician's discretion<br>In each center, all patients meeting the inclusion criteria and no exclusion criteria will be offered to participate in this study. | Drug: Non interventional study<br>* CLL patients initiated with acalabrutinib at their physician's discretion between January 1, 2021 and December 31, 2022 . Secondary data collection<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Time to Discontinuation | Time between first day of acalabrutinib and the day that acalabrutinib is stopped | Up to 3 years from the start of acalabrutinib | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Baseline clinical and demographic characteristics in CLL patients | Demographic characteristics (gender, age BMI) and disease characteristics (age at diagnosis, previous treatment, staging, prognosis criteria, constitutive symptoms) | First interim analysis (year1) and second interim analysis (year2) | 
| Effectiveness of acalabrutinib | Real World Progression Free Survival Overall Survival Time to next treatment or Death | Once a year until end of study (up to 3 years from the start of acalabrutinib) | 
| Major determinants of treatment discontinuation | Multivariate analysis to study correlation between Time to Discontinuation and patient characteristics at baseline | Once a year until end of study (up to 3 years from the start of acalabrutinib) | 
| Acalabrutinib interruption | Percentage of patients with acalabrutinib interruption | Once a year until end of study (up to 3 years from the start of acalabrutinib) | 
| Reasons of acalabrutinib interruption | Reasons of acalabrutinib interruption | Once a year until end of study (up to 3 years from the start of acalabrutinib) | 
| Time to interruption | Time between first day of acalabrutinib and the day of first interruption of acalabrutinib | Once a year until end of study (up to 3 years from the start of acalabrutinib) | 
| Duration interruption | Time between first day of acalabrutinib interruption and the day of acalabrutinib restart | Once a year until end of study (up to 3 years from the start of acalabrutinib) | 
| Acalabrutinib dose changes | Percentage of patients with acalabrutinib dose changes | Once a year until end of study (up to 3 years from the start of acalabrutinib) | 
| Reasons of Acalabrutinib dose changes | Reasons of acalabrutinib dose changes | Once a year until end of study (up to 3 years from the start of acalabrutinib) | 
| Healthcare Resources Utilization : Hospitalization | Number of day of hospitalization | Once a year until end of study (up to 3 years from the start of acalabrutinib) | 
| Healthcare Resources Utilization : Accident and Emergency Visits | Number of Accident and Emergency Visits | Once a year until end of study (up to 3 years from the start of acalabrutinib) | 
| Healthcare Resources Utilization : Outpatient Visits | Number of Outpatient Visits | Once a year until end of study (up to 3 years from the start of acalabrutinib) |