Chronic Lymphocytic LeukemiaALICIA(BY)NCT07288515
Observ Prosp Study of Acalabrutinib in CLL Therapy in Real Clinical Practice in Belarus
An observational study of Chronic Lymphocytic Leukemia, run by AstraZeneca at 4 sites in Belarus.
Trial summary
to address critical gap in knowledge, providing essential data on the real-world effectiveness, safety, associated with acalabrutinib treatment in patients with CLL Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Chronic Lymphocytic Leukemia
- How many people
- 50 participants
- Where
- 4 sitesBelarus
- Study dates
- 31 Dec 2025to 31 Dec 2029
- Phase
- Observational
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Study population: The study population comprises adult patients (≥18 years old) diagnosed with CLL, who have been newly prescribed acalabrutinib monotherapy within four weeks prior to study enrolment. This includes both treatment-naïve patients and patients with relapsed/refractory (R/R) CLL.
Who may be able to join
- 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.
Who cannot join
- 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 locations and contacts
4 sites in 1 country. Contact the study team or a site near you to ask about taking part.
AstraZeneca Clinical Study Information Center contact
Belarus4 sites, 4 recruiting
- Recruiting
Research Site
Grodno
- Not yet recruiting
Research Site
Homyel
- Recruiting
Research Site
Minsk
- Recruiting
Research Site
Mogilev
About this study
Official title: 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
Read the detailed 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.
- Conditions
- Chronic Lymphocytic Leukemia
- Keywords
- CLL
- Medical subject headings
- Leukemia, Lymphocytic, Chronic, B-Cell
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
| Study group | Role | What they receive |
|---|---|---|
| patients with CLL | no control group or comparator involved |
What is being measured
The primary outcome is the main question the study is designed to answer.
Time to treatment discontinuation
defined as the duration (in days) from the initiation of acalabrutinib therapy until the earliest of:
- documented permanent treatment discontinuation as recorded in the patient's medical chart, or
- death from any cause
Measured: up to 25 months
Secondary outcomes (5)
Reasons for treatment discontinuation
Collected from source medical documents (e.g., progression, toxicity, patient preference, physician's decision).
Measured: up to 25 months
Rates for dose modifications
numerical count of dose reductions or holds, and categorization of underlying reasons (e.g., toxicity, drug interactions, comorbidities), derived from medical records
Measured: up to 25 months
reasons for dose modifications
numerical count of dose reductions or holds, and categorization of underlying reasons (e.g., toxicity, drug interactions, comorbidities), derived from medical records
Measured: up to 25 months
Subsequent treatments
qualitative categorical descriptions of therapies following acalabrutinib discontinuation
Measured: up to 25 months
Treatment interruptions
temporary discontinuation of acalabrutinib lasting ≥7 days but <30 days, with documented intent to resume treatment. Interruptions and their documented reasons will be captured from medical records
Measured: up to 25 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted17 Dec 2025
- Study start31 Dec 2025
- Primary completion31 Dec 2029 (estimated)
- Study completion31 Dec 2029 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Chronic Lymphocytic LeukemiaStudies of the same condition, open and under way.
- More trials run by AstraZenecaThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Cohort
- Time perspective
- Prospective
- Enrolment
- 50 participants (estimated)
Sponsor and investigators
- Lead sponsor
- AstraZeneca
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07288515
- Sponsor's protocol ID
- D8220R00090
- Acronym
- ALICIA(BY)
- Status last verified
- Sep 2026
- First submitted
- 17 Nov 2025
- Last updated
- 9 Sep 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Yes: Qualified researchers can request access to anonymized individual patient-level data from AstraZeneca group of companies sponsored clinical trials via the request portal Vivli.org. All requests will be evaluated as per the AZ disclosure commitment: https://astrazenecagrouptrials.pharmacm.com/ST/Submission/Disclosure. Yes, indicates that AZ are accepting requests for IPD, but this does not mean all requests will be shared.