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NCT Number: NCT07288515

Observ Prosp Study of Acalabrutinib in CLL Therapy in Real Clinical Practice in Belarus

to address critical gap in knowledge, providing essential data on the real-world effectiveness, safety, associated with acalabrutinib treatment in patients with CLL

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Key information

Conditions

Chronic Lymphocytic Leukemia Chronic Disease Disease Attributes Hematologic Diseases Hemic and Lymphatic Diseases Immune System Diseases Immunoproliferative Disorders Leukemia Leukemia, B-Cell Leukemia, Lymphocytic, Chronic, B-Cell Leukemia, Lymphoid Lymphatic Diseases Lymphoproliferative Disorders Neoplasms Neoplasms by Histologic Type Pathologic Processes Pathological Conditions, Signs and Symptoms

Age range

18 year and older

Sex eligibility

All sexes

Study type

Observational

Primary location

Research Site, Grodno, Belarus

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About this study

This observational, prospective, multi-center study aims to gather real-world data (RWD) on acalabrutinib's use in routine clinical practice for CLL treatment in Belarus. Patients will be monitored without intervention, and all treatment decisions will be at the clinician's discretion. The study duration per patient will be approximately two years, with periodic data collection at regular intervals, ensuring comprehensive assessment of treatment effectiveness, patient safety, and quality of life metrics.

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.
  • Newly prescribed acalabrutinib monotherapy within the previous four weeks preceding study enrolment. Monotherapy is defined as acalabrutinib prescribes without concomitant administration (or planned initiation) of other anti-leukemic agents (e.g. obinutuzumab, venetoclax, bendamustine) within ± 30 days of acalabrutinib initiation.
  • Treatment-naïve or R/R CLL.
  • Ability and willingness to provide informed consent for study participation.

Exclusion criteria

  • Patients not satisfying any of the inclusion criteria.
  • Prior treatment with any BTK inhibitor.
  • Participation in other ongoing clinical trials.
  • Pregnant or breastfeeding females

Treatment and study plan

Primary outcomes

  1. Time to treatment discontinuation

    Time frame: up to 25 months

    defined as the duration (in days) from the initiation of acalabrutinib therapy until the earliest of:

    • documented permanent treatment discontinuation as recorded in the patient's medical chart, or
    • death from any cause

Secondary outcomes

  1. Reasons for treatment discontinuation

    Time frame: up to 25 months

    Collected from source medical documents (e.g., progression, toxicity, patient preference, physician's decision).

  2. Rates for dose modifications

    Time frame: up to 25 months

    numerical count of dose reductions or holds, and categorization of underlying reasons (e.g., toxicity, drug interactions, comorbidities), derived from medical records

  3. reasons for dose modifications

    Time frame: up to 25 months

    numerical count of dose reductions or holds, and categorization of underlying reasons (e.g., toxicity, drug interactions, comorbidities), derived from medical records

  4. Subsequent treatments

    Time frame: up to 25 months

    qualitative categorical descriptions of therapies following acalabrutinib discontinuation

  5. Treatment interruptions

    Time frame: up to 25 months

    temporary discontinuation of acalabrutinib lasting ≥7 days but <30 days, with documented intent to resume treatment. Interruptions and their documented reasons will be captured from medical records

Other outcomes

  1. PFS measures, including one- and two-year rates

    Time frame: up to 25 months

    PFS, defined as the time from first dose to documented progression or death, assessed by Investigator based on clinical evaluations and diagnostic imaging, when available.

  2. OS rates

    Time frame: up to 25 months

    OS rates at one and two years of follow-up defined as proportion of alive participants at the given timepoint

Study contacts

Contact information is provided by the study sponsor or research team.

AstraZeneca Clinical Study Information Center

CONTACT

[email protected]

1-877-240-9479

Sponsors and collaborators

Lead sponsor

AstraZeneca

Industry

Registry information

Official study title

Observational Prospective Study of Acalabrutinib in Chronic Lymphocytic Leukemia Therapy in Real Clinical Practice in Belarus.

Acronym: ALICIA(BY)

Important dates

Study start
2025
Primary completion
2029
Study completion
2029
First posted
Dec 17, 2025
Registry last updated
Sep 9, 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.

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