REAl-world Outcomes in CHronic Lymphocytic Leukemia Patients Receiving Acalabrutinib in Romania

Study Overview
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Brief Summary
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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.

Official Title
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Observational, Secondary Data Collection Study to Describe Acalabrutinib Treatment Outcomes in Chronic Lymphocytic Leukemia Patients in Real-life Setting in Romania

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: 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 Exclusion Criteria: The treatment with acalabrutinib was initiated during an interventional clinical trial Enrolment performed less than 30 days from start of treatment with acalabrutinib

Ages Eligible for Study
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Minimum Age: 18 Years
Maximum Age: 130 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 |
| --- | --- |
| Cohort 1<br>December 2023 - collecting data retrospectively from patients routinely initiated on acalabrutinib between January - December 2023 | Drug: Non interventional study<br>* CLL patients routinely initiated on acalabrutinib by their physician between January 2023 -December 2024. Retrospective secondary data collection<br>|
| Cohort 2<br>December 2024-collecting data retrospectively from patients routinely initated on acalabrutinib between January - December 2024 | Drug: Non interventional study<br>* CLL patients routinely initiated on acalabrutinib by their physician between January 2023 -December 2024. Retrospective secondary data collection<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Time to acalabrutinib treatment discontinuation (TTD) | 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 | Once a year during the 3 years of follow up since acalabrutinib start | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Reasons for treatment discontinuation | Reasons for acalabrutinib interruption | Once a year until end of the study ( 3 years from start of acalabrutinib) | 
| effectiveness of acalabrutinib | Real world progression free survival (rwPFS) is defined as the time from initiation of acalabrutinib therapy (index date) until earliest record of disease progression determined by physicians' assessment (clinical or radiological progression or start of a new line therapy),or death | Once a year until end of the study ( 3 years from start of acalabrutinib) | 
| Baseline clinical and demographic characteristics | Demographic characteristics (age,gender, BMI) and disease characteristics (age at diagnosis, staging, symptoms, active disease criteria,previous treatment | At first data collection for cohort 1 in December 2023 and at first data collection for cohort 2 in December 2024 | 
| acalabrutinib interruption | Percentage of patients with acalabrutinib interruption | Once a year until end of the study (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 the study ( 3 years from start of acalabrutinib) | 
| duration of interruption | Time between the first day of acalabrutinib interruption and the first day of acalabrutinib restart | once a year until the end of the study ( 3 years from acalabrutinib start) | 
| acalabrutinib dose changes | Percentage of patients with dose changes | once a year until the end of the study ( 3 years from acalabrutinib start) | 
| Reasons of acalabrutinib dose changes | Reasons of acalabrutinib dose changes (all including adverse events) | once a year until the end of the study ( 3 years from acalabrutinib start) | 
| Major determinant of treatment discontinuation | a multivariate analysis (Cox model) will be performed to study correlation between TTD and patient characteristics at baseline. | once a year until end of the study( 3 years from acalabrutinib start) |