Clinical trial NCT06170671: REAl-world Outcomes in CHronic Lymphocytic Leukemia Patients Receiving Acalabrutinib in Romania
Official title: Observational, Secondary Data Collection Study to Describe Acalabrutinib Treatment Outcomes in Chronic Lymphocytic Leukemia Patients in Real-life Setting in Romania
Study type: OBSERVATIONAL
Overall status: ACTIVE_NOT_RECRUITING
Conditions: Chronic Lymphocytic Leukemia
Lead sponsor: AstraZeneca
Sponsor class: INDUSTRY
First posted: 2023-12-14
Enrollment: 250
Sex: ALL
Minimum age (years): 18
Maximum age (years): 130
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: COHORT
Time perspective: RETROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: CLL patients routinely initiated on acalabrutinib in front-line or subsequent treatment during the study eligibility window January 2023-December 2024

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..


Eligibility criteria: 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

Primary outcomes:
measure: Time to acalabrutinib treatment discontinuation (TTD)
timeFrame: Once a year during the 3 years of follow up since acalabrutinib start
Secondary outcomes:
measure: Reasons for treatment discontinuation
timeFrame: Once a year until end of the study ( 3 years from start of acalabrutinib)
measure: effectiveness of acalabrutinib
timeFrame: Once a year until end of the study ( 3 years from start of acalabrutinib)
measure: Baseline clinical and demographic characteristics
timeFrame: At first data collection for cohort 1 in December 2023 and at first data collection for cohort 2 in December 2024
measure: acalabrutinib interruption
timeFrame: Once a year until end of the study (3 years from the start of acalabrutinib)
measure: time to interruption
timeFrame: Once a year until end of the study ( 3 years from start of acalabrutinib)
measure: duration of interruption
timeFrame: once a year until the end of the study ( 3 years from acalabrutinib start)
measure: acalabrutinib dose changes
timeFrame: once a year until the end of the study ( 3 years from acalabrutinib start)
measure: Reasons of acalabrutinib dose changes
timeFrame: once a year until the end of the study ( 3 years from acalabrutinib start)
measure: Major determinant of treatment discontinuation
timeFrame: once a year until end of the study( 3 years from acalabrutinib start)
Other outcomes:
Locations:
city: Pitesti
country: Romania
facility: Research Site
state: Arges
city: Oradea
country: Romania
facility: Research Site
state: Bihor
city: Cluj Napoca
country: Romania
facility: Research Site
state: Cluj
city: Craiova
country: Romania
facility: Research Site
state: Dolj
city: Deva
country: Romania
facility: Research Site
state: Hunedoara
city: Baia Mare
country: Romania
facility: Research Site
state: Maramures
city: Targu Mures
country: Romania
facility: Research Site
state: Mures
city: Piatra Neamt
country: Romania
facility: Research Site
state: Neamt
city: Timisoara
country: Romania
facility: Research Site
state: Timis
city: Timisoara
country: Romania
facility: Research Site
state: Timis
city: Focsani
country: Romania
facility: Research Site
state: Vrancea
city: Brasov
country: Romania
facility: Research Site
city: Bucuresti
country: Romania
facility: Research Site
city: Bucuresti
country: Romania
facility: Research Site
city: Bucuresti
country: Romania
facility: Research Site
city: Bucuresti
country: Romania
facility: Research Site
city: Bucuresti
country: Romania
facility: Research Site
city: Galati
country: Romania
facility: Research Site
city: Iasi
country: Romania
facility: Research Site
Study officials:
References: