ALICIA (Acalabrutinib in CLL Therapy)

Last updated: April 4, 2025
Sponsor: AstraZeneca
Overall Status: Active - Not Recruiting

Phase

N/A

Condition

Platelet Disorders

Leukemia

Lymphoproliferative Disorders

Treatment

N/A

Clinical Study ID

NCT04746950
D8220R00021
  • Ages > 18
  • All Genders

Study 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

Eligibility Criteria

Inclusion

Inclusion Criteria:

  • Age ≥18 years

  • Confirmed diagnosis of CLL

  • Patient started treatment with monotherapy acalabrutinib (prescribed by physiciandecision no more than 4 weeks ago before screening)

  • Capability of providing written Informed Consent Form

Exclusion

Exclusion Criteria:

  • Patients not corresponded to inclusion criteria

  • Pregnancy

  • Lactation

  • Patients included in open-label trials

  • Previous Bruton tyrosine kinase inhibitors (BTKI) treatment

Study Design

Total Participants: 90
Study Start date:
February 03, 2021
Estimated Completion Date:
December 31, 2025

Connect with a study center

  • Research Site

    Ufa, Bashkortostan Republic 450054
    Russian Federation

    Site Not Available

  • Research Site

    Kaliningrad, Kaliningrad Region
    Russian Federation

    Site Not Available

  • Research Site

    Khabarovsk, Khabarovsk Region 680009
    Russian Federation

    Site Not Available

  • Research Site

    Syktyvkar, Komi Republic
    Russian Federation

    Site Not Available

  • Research Site

    Krasnoyarsk, Krasnoyarsk Region 660022
    Russian Federation

    Site Not Available

  • Research Site

    Saint Petersburg, Leningrad Region 198205
    Russian Federation

    Site Not Available

  • Research Site

    Moscow, Moscow Region 129110
    Russian Federation

    Site Not Available

  • Research Site

    Nizhny Novgorod, Nizhny Novgorod Region
    Russian Federation

    Site Not Available

  • Research Site

    Novosibirsk, Novosibirsk Region 630091
    Russian Federation

    Site Not Available

  • Research Site

    Yakutsk, Sakha Republic 677008
    Russian Federation

    Site Not Available

  • Research Site

    Saratov, Saratov Region 410028
    Russian Federation

    Site Not Available

  • Research Site

    Irkutsk,
    Russian Federation

    Site Not Available

  • Research Site

    Kalinigrad,
    Russian Federation

    Site Not Available

  • Central city clinical hospital

    Kaliningrad,
    Russian Federation

    Site Not Available

  • Research Site

    Nizhniy Novgorod, 603126
    Russian Federation

    Site Not Available

  • Research Site

    Tomsk, 634063
    Russian Federation

    Site Not Available

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