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NCT04746950Completed

ALICIA (Acalabrutinib in CLL Therapy)

ALICIA (Observational Prospective Study of Acalabrutinib in CLL Therapy in Real Clinical Practice in Russia)

Source: ClinicalTrials.gov · Last updated 17 Jul 2026

Brief summary (registry, in English)

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

Status (registry)
Completed
Study type
Observational
Enrollment
90 (actual)
First submitted
23 Dec 2020
Start date
3 Feb 2021
Primary completion date
28 Feb 2026
Lead sponsor
AstraZeneca
NCT number
NCT04746950

What you commit to

  • Study type: Observational
  • Participants enrolled: 90
  • From 3 Feb 2021 to the primary completion date, 28 Feb 2026
  • 12 sites in 1 country
  • Visits and tests: ask the trial team, the registry does not list them

Built from the registry fields of ClinicalTrials.gov. It describes the study, not your situation.

Who cannot take part

Copied verbatim from ClinicalTrials.gov and grouped by topic. Only the trial team decides who can take part.

Prior treatment

  • Previous Bruton tyrosine kinase inhibitors (BTKI) treatment

Other

  • Patients not corresponded to inclusion criteria
  • Pregnancy
  • Lactation
  • Patients included in open-label trials

Who the study is looking for

  • 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

Age in the registry: 18 years to - · Sex: All · Does not accept healthy volunteers

Full criteria on ClinicalTrials.gov

Sites (12)

Sites in registry order. Pick your city on the disease page to sort them by distance.

SiteCityCountrySite status
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Coordinator of this site? Confirm its status
KaliningradRussiaUnknown status
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Coordinator of this site? Confirm its status
KhabarovskRussiaUnknown status
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Coordinator of this site? Confirm its status
KrasnoyarskRussiaUnknown status
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Coordinator of this site? Confirm its status
MoscowRussiaUnknown status
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Coordinator of this site? Confirm its status
Nizhny NovgorodRussiaUnknown status
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Coordinator of this site? Confirm its status
NovosibirskRussiaUnknown status
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Coordinator of this site? Confirm its status
Saint PetersburgRussiaUnknown status
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Coordinator of this site? Confirm its status
SaratovRussiaUnknown status
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Coordinator of this site? Confirm its status
SyktyvkarRussiaUnknown status
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Coordinator of this site? Confirm its status
TomskRussiaUnknown status
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Coordinator of this site? Confirm its status
UfaRussiaUnknown status
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Coordinator of this site? Confirm its status
YakutskRussiaUnknown status

This page is information, not medical advice. Discuss any trial with your doctor.