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..
Study Type
OBSERVATIONAL
Enrollment
250
CLL patients routinely initiated on acalabrutinib by their physician between January 2023 -December 2024. Retrospective secondary data collection
Research Site
Piteşti, Argeş, Romania
Research Site
Oradea, Bihor County, Romania
Research Site
Cluj-Napoca, Cluj, Romania
Research Site
Craiova, Dolj, Romania
Research Site
Deva, Hunedoara County, Romania
Research Site
Baia Mare, Maramureş, Romania
Research Site
Târgu Mureş, Mureș County, Romania
Research Site
Piatra Neamţ, Neamț County, Romania
Research Site
Timișoara, Timiș County, Romania
Research Site
Timișoara, Timiș County, Romania
...and 9 more locations
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
Time frame: Once a year during the 3 years of follow up since acalabrutinib start
Reasons for treatment discontinuation
Reasons for acalabrutinib interruption
Time frame: 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
Time frame: 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
Time frame: 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
Time frame: 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
Time frame: 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
Time frame: once a year until the end of the study ( 3 years from acalabrutinib start)
acalabrutinib dose changes
Percentage of patients with dose changes
Time frame: 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)
Time frame: 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.
Time frame: once a year until end of the study( 3 years from acalabrutinib start)
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