Acalabrutinib for CLL in routine care in Belarus
Observational Prospective Study of Acalabrutinib in Chronic Lymphocytic Leukemia Therapy in Real Clinical Practice in Belarus.
This project will see how well acalabrutinib works and how safe it is for adults with chronic lymphocytic leukemia treated in routine clinical practice in Belarus.
Quick facts
| Study type | Observational |
|---|---|
| Enrollment | 50 (estimated) |
| Ages | 18 Years and up |
| Sex | All |
| Sponsor | AstraZeneca Industry-sponsored |
| Drugs / interventions | obinutuzumab, acalabrutinib |
| Locations | 1 site (Minsk) |
| Trial ID | NCT07288515 on ClinicalTrials.gov |
What this trial studies
This is a prospective, observational, multi-center cohort that will collect real-world data on patients with CLL who start acalabrutinib monotherapy in Belarus. Patients will receive usual care with no study-mandated treatment changes, and clinicians will make all treatment decisions independently. Each patient will be followed for about two years with scheduled data collection on treatment exposure, clinical outcomes, adverse events, and quality of life. The goal is to describe effectiveness and safety of acalabrutinib in routine practice rather than to alter patient care.
Who should consider this trial
Good fit: Adults (age ≥18) with a confirmed diagnosis of CLL who were newly prescribed acalabrutinib monotherapy within the prior four weeks, whether treatment‑naïve or relapsed/refractory, and who can give informed consent are ideal candidates.
Not a fit: Patients previously treated with any BTK inhibitor, those enrolled in other clinical trials, and pregnant or breastfeeding individuals are excluded and would not benefit from this project.
Why it matters
Potential benefit: If successful, the project could provide locally relevant effectiveness and safety data to help clinicians choose and manage acalabrutinib treatment for CLL patients in Belarus.
How similar studies have performed: Randomized trials and international real-world cohorts have shown acalabrutinib to be effective and generally well tolerated in CLL, but prospective real-world data specifically from Belarus are limited.
Eligibility criteria
Show full inclusion / exclusion criteria
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
Where this trial is running
Minsk
- Research Site — Minsk, Belarus (Recruiting)
Study contacts
- Study coordinator: AstraZeneca Clinical Study Information Center
- Email: information.center@astrazeneca.com
- Phone: 1-877-240-9479
How to participate
- Review the eligibility criteria above with your treating physician.
- Visit the official trial page on ClinicalTrials.gov for the most current contact information and recruitment status.
- Contact the listed study coordinator or principal investigator to request pre-screening. Pre-screening is free and never obligates you to enroll.