Chronic Lymphocytic LeukemiaALICIANCT04746950
ALICIA (Acalabrutinib in CLL Therapy)
An observational study of Chronic Lymphocytic Leukemia, run by AstraZeneca at 15 sites in Russia.
Trial summary
This is a multicenter non-interventional observational study conducted with a single hand arm to collect real-world data. In this study, commercially available acalabrutinib will be used as prescribed treatment for CLL as per the treating physician's best clinical judgement. 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
- 90 participants
- Where
- 15 sitesRussia
- Study dates
- 3 Feb 2021to 28 Feb 2026
- Phase
- Observational
- Are there results?
- None posted in the registry
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 Enrolled set will be represented by eligible patients who have signed an informed consent form to participate in the study. It is estimated that approximately 200 patients will be enrolled in the study. Study population will consist of adult patients with diagnosed CLL ≥ 18 years old (treatment naïve (TN) or relapsed/refractory (R/R)) for whom acalabrutinib in monotherapy was prescribed by treating physician decision no more than 4 weeks ago before screening.
Who may be able to join
- Age ≥18 years
- Confirmed diagnosis of CLL
- Patient started treatment with monotherapy acalabrutinib (prescribed by physician decision no more than 4 weeks ago before screening)
- Capability of providing written Informed Consent Form
Who cannot join
- Patients not corresponded to inclusion criteria
- Pregnancy
- Lactation
- Patients included in open-label trials
- Previous Bruton tyrosine kinase inhibitors (BTKI) treatment
Trial locations and contacts
15 sites in 1 country.
15 sites in 1 country
Russia15 sites
Research Site
Kaliningrad, Kaliningrad Oblast
Research Site
Kaliningrad
Research Site
Khabarovsk, Khabarovskiy Kray, 680009
Research Site
Krasnoyarsk, Krasnoyarsk Region, 660022
Research Site
Moscow, Moscow Oblast, 125284
Research Site
Moscow, Moscow Oblast, 129110
Research Site
Nizhny Novgorod, Nizhny Novgorod Oblast
Research Site
Nizhny Novgorod
Research Site
Novosibirsk, Novosibirsk Oblast, 630091
Research Site
Saint Petersburg, Leningradskaya Oblast', 198205
Research Site
Saratov, Saratov Oblast, 410028
Research Site
Syktyvkar, Komi
Research Site
Tomsk
Research Site
Ufa, Bashkortostan Republic, 450054
Research Site
Yakutsk, Sakha Republic, 677008
About this study
Official title: ALICIA (Observational Prospective Study of Acalabrutinib in CLL Therapy in Real Clinical Practice in Russia)
This is a multicenter non-interventional observational study conducted with a single hand arm to collect real-world data. In this study, commercially available acalabrutinib will be used as prescribed treatment for CLL as per the treating physician's best clinical judgement. No additional procedures besides those already used in the routine clinical practice will be applied to the patients. Treatment assignment will be done according to the current practice.
A multi-center collaborative effort in 15 centers selected from regions within Russia will help capture more patients into the database, rather than limiting the data to a single institution. This will be critical for:
Read more
- increasing database sample size
- reducing bias (single institution bias)
- increasing result's generalizability to the whole Russian population Being an observational study, only data available from routine clinical practice and standard of care (SoC), in line with national and international laws and regulations, will be recorded.
Patients will be treated according to prescribing information, with visit frequency and assessments performed according to routine medical practice and SoC. Only data corresponding to these visits and assessments will be collected as part of the study.
Data for the study will be transcribed and entered into an electronic Case Report Form (eCRF) from the patient's medical records. The site investigator will be responsible for ensuring that all required data is collected and entered into the eCRF with the involvement of clinical research organization
- Conditions
- Chronic Lymphocytic Leukemia
- Keywords
- chronic lymphocytic leukemia
- Medical subject headings
- Leukemia, Lymphocytic, Chronic, B-Cell
What is being measured
The primary outcome is the main question the study is designed to answer.
• progression-free survival (rwPFS) in patients with CLL who are treated with acalabrutinib in clinical practice in Russia
Measured: Up to 2 years
• incidence of adverse events and serious adverse events in CLL patients treated with acalabrutinib in clinical practice in Russia
Measured: Up to 2 years
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted10 Feb 2021
- Study start3 Feb 2021
- Primary completion28 Feb 2026
- Study completion28 Feb 2026
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
- Case-control
- Time perspective
- Prospective
- Enrolment
- 90 participants (actual)
Sponsor and investigators
- Lead sponsor
- AstraZeneca
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04746950
- Sponsor's protocol ID
- D8220R00021
- Acronym
- ALICIA
- Status last verified
- Jul 2026
- First submitted
- 23 Dec 2020
- Last updated
- 17 Jul 2026
- Results posted
- 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. All request 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.
Study at a glance
From the registry record, last updated by the sponsor on 17 Jul 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- ALICIA (Observational Prospective Study of Acalabrutinib in CLL Therapy in Real Clinical Practice in Russia)
- ClinicalTrials.gov ID
- NCT04746950
- Acronym / sponsor ID
- ALICIA / D8220R00021
- Conditions
- Chronic Lymphocytic Leukemia
- Keywords
- chronic lymphocytic leukemia
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 90 participants (actual)
- Lead sponsor
- AstraZenecaIndustry (pharma, biotech, devices)
- Study start
- 3 Feb 2021 (actual)
- Primary completion
- 28 Feb 2026 (actual)
- Study completion
- 28 Feb 2026 (actual)
- First posted
- 10 Feb 2021 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
This is a multicenter non-interventional observational study conducted with a single hand arm to collect real-world data. In this study, commercially available acalabrutinib will be used as prescribed treatment for CLL as per the treating physician's best clinical judgement. No additional procedures besides those already used in the routine clinical practice will be applied to the patients. Treatment assignment will be done according to the current practice.
A multi-center collaborative effort in 15 centers selected from regions within Russia will help capture more patients into the database, rather than limiting the data to a single institution. This will be critical for:
- increasing database sample size
- reducing bias (single institution bias)
- increasing result's generalizability to the whole Russian population Being an observational study, only data available from routine clinical practice and standard of care (SoC), in line with national and international laws and regulations, will be recorded.
Patients will be treated according to prescribing information, with visit frequency and assessments performed according to routine medical practice and SoC. Only data corresponding to these visits and assessments will be collected as part of the study.
Data for the study will be transcribed and entered into an electronic Case Report Form (eCRF) from the patient's medical records. The site investigator will be responsible for ensuring that all required data is collected and entered into the eCRF with the involvement of clinical research organization
Study design
- Observational model
- Case-control
- Time perspective
- Prospective
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- The Enrolled set will be represented by eligible patients who have signed an informed consent form to participate in the study. It is estimated that approximately 200 patients will be enrolled in the study. Study population will consist of adult patients with diagnosed CLL ≥ 18 years old (treatment naïve (TN) or relapsed/refractory (R/R)) for whom acalabrutinib in monotherapy was prescribed by treating physician decision no more than 4 weeks ago before screening.
Key inclusion criteria (4 listed)
- Age ≥18 years
- Confirmed diagnosis of CLL
- Patient started treatment with monotherapy acalabrutinib (prescribed by physician decision no more than 4 weeks ago before screening)
- Capability of providing written Informed Consent Form
Key exclusion criteria (5 listed)
- Patients not corresponded to inclusion criteria
- Pregnancy
- Lactation
- Patients included in open-label trials
- Previous Bruton tyrosine kinase inhibitors (BTKI) treatment
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Primary outcome
• progression-free survival (rwPFS) in patients with CLL who are treated with acalabrutinib in clinical practice in Russia
Time frame: Up to 2 years
• incidence of adverse events and serious adverse events in CLL patients treated with acalabrutinib in clinical practice in Russia
Time frame: Up to 2 years
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 17 Jul 2026.
- Individual participant dataSharing planned: Yes. Qualified researchers can request access to anonymized individual patient-level data from AstraZeneca group of companies sponsored clinical trials via the request portal. All request 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.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
The record lists no contact. Use the official record to reach the sponsor.
15 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Chronic Lymphocytic Leukemia, run by AstraZeneca at 15 sites in Russia.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 4 inclusion and 5 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 17 Jul 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 15 sites in Russia. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
• progression-free survival (rwPFS) in patients with CLL who are treated with acalabrutinib in clinical practice in Russia (time frame: Up to 2 years). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 17 Jul 2026.