Chronic Lymphocytic Leukemia
Conditions
Brief summary
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..
Interventions
DRUGNon interventional study
CLL patients routinely initiated on acalabrutinib by their physician between January 2023 -December 2024. Retrospective secondary data collection
Sponsors
AstraZeneca
Study design
Observational model
COHORT
Time perspective
RETROSPECTIVE
Eligibility
Sex/Gender
ALL
Age
18 Years to 130 Years
Healthy volunteers
No
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
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Time to acalabrutinib treatment discontinuation (TTD) | Once a year during the 3 years of follow up since acalabrutinib start | 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 |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Reasons for treatment discontinuation | Once a year until end of the study ( 3 years from start of acalabrutinib) | Reasons for acalabrutinib interruption |
| effectiveness of acalabrutinib | Once a year until end of the study ( 3 years from start 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 |
| Baseline clinical and demographic characteristics | At first data collection for cohort 1 in December 2023 and at first data collection for cohort 2 in December 2024 | Demographic characteristics (age,gender, BMI) and disease characteristics (age at diagnosis, staging, symptoms, active disease criteria,previous treatment |
| acalabrutinib interruption | Once a year until end of the study (3 years from the start of acalabrutinib) | Percentage of patients with acalabrutinib interruption |
| time to interruption | Once a year until end of the study ( 3 years from start of acalabrutinib) | Time between first day of acalabrutinib and the day of first interruption of acalabrutinib |
| duration of interruption | once a year until the end of the study ( 3 years from acalabrutinib start) | Time between the first day of acalabrutinib interruption and the first day of acalabrutinib restart |
| acalabrutinib dose changes | once a year until the end of the study ( 3 years from acalabrutinib start) | Percentage of patients with dose changes |
| Reasons of acalabrutinib dose changes | once a year until the end of the study ( 3 years from acalabrutinib start) | Reasons of acalabrutinib dose changes (all including adverse events) |
| Major determinant of treatment discontinuation | once a year until end of the study( 3 years from acalabrutinib start) | a multivariate analysis (Cox model) will be performed to study correlation between TTD and patient characteristics at baseline. |
Countries
Romania
Outcome results
None listed