REAl-world Outcomes in CHronic Lymphocytic Leukemia Patients Receiving Acalabrutinib in Romania
- Conditions
- Chronic Lymphocytic Leukemia
- Interventions
- Drug: Non interventional study
- Registration Number
- NCT06170671
- Lead Sponsor
- AstraZeneca
- 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..
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- ACTIVE_NOT_RECRUITING
- Sex
- All
- Target Recruitment
- 250
- 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
- The treatment with acalabrutinib was initiated during an interventional clinical trial
- Enrolment performed less than 30 days from start of treatment with acalabrutinib
Study & Design
- Study Type
- OBSERVATIONAL
- Study Design
- Not specified
- Arm && Interventions
Group Intervention Description Cohort 1 Non interventional study December 2023 - collecting data retrospectively from patients routinely initiated on acalabrutinib between January - December 2023 Cohort 2 Non interventional study December 2024-collecting data retrospectively from patients routinely initated on acalabrutinib between January - December 2024
- Primary Outcome Measures
Name Time Method 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 Outcome Measures
Name Time Method 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
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.
Reasons for treatment discontinuation Once a year until end of the study ( 3 years from start of acalabrutinib) Reasons for acalabrutinib interruption
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
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
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
acalabrutinib dose changes once a year until the end of the study ( 3 years from acalabrutinib start) Percentage of patients with dose changes
acalabrutinib interruption Once a year until end of the study (3 years from the start of acalabrutinib) Percentage of patients with acalabrutinib interruption
Trial Locations
- Locations (1)
Research Site
🇷🇴Iasi, Romania