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

AstraZeneca

Status: Active, not recruiting

Conditions: Chronic Lymphocytic Leukemia

Treatments: Drug: Non interventional study

Study type: Observational

Funder types: Industry

Identifiers

NCT06170671

D8220R00055

Details and patient eligibility

About

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..

Enrollment: 250 estimated patients

Sex: All

Ages: 18 to 130 years old

Volunteers: No Healthy Volunteers

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

Trial design

250 participants in 2 patient groups

Cohort 1

Description:

December 2023 - collecting data retrospectively from patients routinely initiated on acalabrutinib between January - December 2023

Treatment:

Drug: Non interventional study

Cohort 2

Description:

December 2024-collecting data retrospectively from patients routinely initated on acalabrutinib between January - December 2024

Treatment:

Drug: Non interventional study