Observ Prosp Study of Acalabrutinib in CLL Therapy in Real Clinical Practice in Belarus

Observational Prospective Study of Acalabrutinib in Chronic Lymphocytic Leukemia Therapy in Real Clinical Practice in Belarus.

to address critical gap in knowledge, providing essential data on the real-world effectiveness, safety, associated with acalabrutinib treatment in patients with CLL

This observational, prospective, multi-center study aims to gather real-world data (RWD) on acalabrutinib's use in routine clinical practice for CLL treatment in Belarus. Patients will be monitored without intervention, and all treatment decisions will be at the clinician's discretion. The study duration per patient will be approximately two years, with periodic data collection at regular intervals, ensuring comprehensive assessment of treatment effectiveness, patient safety, and quality of life metrics.

Inclusion Criteria:

• Age ≥18 years.
• Confirmed diagnosis of CLL.
• Newly prescribed acalabrutinib monotherapy within the previous four weeks preceding study enrolment. Monotherapy is defined as acalabrutinib prescribes without concomitant administration (or planned initiation) of other anti-leukemic agents (e.g. obinutuzumab, venetoclax, bendamustine) within ± 30 days of acalabrutinib initiation.
• Treatment-naïve or R/R CLL.
• Ability and willingness to provide informed consent for study participation.

Exclusion Criteria:

• Patients not satisfying any of the inclusion criteria.
• Prior treatment with any BTK inhibitor.
• Participation in other ongoing clinical trials.
• Pregnant or breastfeeding females