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Completed

NCT Number: NCT04746950

ALICIA (Acalabrutinib in CLL Therapy)

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

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Key information

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

  • 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

Exclusion criteria

  • Patients not corresponded to inclusion criteria
  • Pregnancy
  • Lactation
  • Patients included in open-label trials
  • Previous Bruton tyrosine kinase inhibitors (BTKI) treatment

Treatment and study plan

Primary outcomes

  1. • progression-free survival (rwPFS) in patients with CLL who are treated with acalabrutinib in clinical practice in Russia

    Time frame: Up to 2 years

  2. • 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

Sponsors and collaborators

Lead sponsor

AstraZeneca

Industry

Registry information

Official study title

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

Acronym: ALICIA

Important dates

Study start
2021
Primary completion
2026
Study completion
2026
First posted
Feb 10, 2021
Registry last updated
Jul 17, 2026

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

Published trials that share one or more normalized conditions with this study.