Observ Prosp Study of Acalabrutinib in CLL Therapy in Real Clinical Practice in Belarus (ALICIA(BY))

AstraZeneca

Status: Not yet enrolling

Conditions: Chronic Lymphocytic Leukemia

Study type: Observational

Funder types: Industry

Identifiers

NCT07288515

D8220R00090

Details and patient eligibility

About

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

Full description

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.

Enrollment: 50 estimated patients

Sex: All

Ages: 18+ years old

Volunteers: No Healthy Volunteers

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

Trial design

50 participants in 1 patient group

patients with CLL

Description:

no control group or comparator involved