Acalabrutinib for CLL in routine care in Belarus
Official title: Observational Prospective Study of Acalabrutinib in Chronic Lymphocytic Leukemia Therapy in Real Clinical Practice in Belarus.
Run by AstraZeneca · NCT07288515 · Data updated 2026-11-12
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 |
|---|---|
| Ages | 18 Years and up |
| Sex | All |
| Enrollment | 50 (estimated) |
| Sponsor | AstraZeneca Industry-sponsored |
| Drugs / interventions | obinutuzumab, acalabrutinib |
| Locations | 4 sites (Grodno and 3 other locations) |
| Status | Recruiting |
| Started | December 31, 2025 |
| Main results expected | December 31, 2029 |
| Study ends | December 31, 2029 |
| Registry record updated | September 9, 2026 |
| Trial ID | NCT07288515 on ClinicalTrials.gov |
Is this trial a fit for you?
✓Likely a 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.
✕Probably 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.
A plain-English reading of the study's rules. Only the study team can confirm whether you qualify.
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.
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 gone: 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.
Who can join: the full rules
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 it's running
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Research Site
Grodno, Belarus Recruiting -
Research Site
Minsk, Belarus Recruiting -
Research Site
Mogilev, Belarus Recruiting -
Research Site
Homyel, Belarus Not yet recruiting
Study contacts
- Study coordinator: AstraZeneca Clinical Study Information Center
- Email: information.center@astrazeneca.com
- Phone: 1-877-240-9479
Similar studies
Other studies for the same condition or treatment. Recruiting studies are listed first.
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Tafasitamab plus Acalabrutinib and Venetoclax for newly treated CLL/SLL
This phase II study tests a combination of tafasitamab, acalabrutinib, and venetoclax in adults who are newly diagnosed with chronic lymphocytic leukemia or small lymphocytic lymphoma to see if it is safe and effective.
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Sonrotoclax plus zanubrutinib versus venetoclax plus acalabrutinib for adults with untreated CLL
This tests whether a fixed-duration combination of sonrotoclax plus zanubrutinib works as well as or better than venetoclax plus acalabrutinib for adults with previously untreated CLL who need treatment.
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Intermittent versus continuous venetoclax with acalabrutinib in CLL/SLL
This will test whether giving venetoclax intermittently or continuously together with acalabrutinib helps people with previously untreated CLL or SLL.
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Quality of life for people with CLL treated with acalabrutinib in France (PLATON database retrospective analysis)
This project will test how quality of life changes during the first 12 months in adults with CLL who start acalabrutinib in real-world care in France.
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Evaluating the risk of tumor lysis syndrome in adults with chronic lymphocytic leukemia receiving venetoclax with obinutuzumab or acalabrutinib
This study is testing if the combination of venetoclax with either obinutuzumab or acalabrutinib is safe for adults with untreated chronic lymphocytic leukemia.
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Comparing Nemtabrutinib to Ibrutinib or Acalabrutinib for First Line Treatment of Chronic Lymphocytic Leukemia
This study is testing if a new drug called nemtabrutinib works as well as or better than two existing treatments for people with chronic lymphocytic leukemia who haven’t had treatment before.
How to take part
- Review the eligibility criteria above with your treating physician.
- Check the official listing on ClinicalTrials.gov for the latest contact details and recruitment status.
- Contact the study coordinator or principal investigator to ask for pre-screening. Pre-screening is free and never obligates you to enroll.