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ALICIA (Acalabrutinib in CLL Therapy)

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

Status
Completed
Phases
Unknown
Study type
Observational
Source
ClinicalTrials.gov
Registry ID
NCT04746950
Acronym
ALICIA
Enrollment
90
Registered
2021-02-10
Start date
2021-02-03
Completion date
2026-02-28
Last updated
2026-07-17

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Chronic Lymphocytic Leukemia

Keywords

chronic lymphocytic leukemia

Brief 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. 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

Interventions

None listed

Sponsors

AstraZeneca
Lead SponsorINDUSTRY

Study design

Observational model
CASE_CONTROL
Time perspective
PROSPECTIVE

Eligibility

Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No

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

Design outcomes

Primary

MeasureTime frame
• progression-free survival (rwPFS) in patients with CLL who are treated with acalabrutinib in clinical practice in RussiaUp to 2 years
• incidence of adverse events and serious adverse events in CLL patients treated with acalabrutinib in clinical practice in RussiaUp to 2 years

Countries

Russia

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Jul 18, 2026