Observ Prosp Study of Acalabrutinib in CLL Therapy in Real Clinical Practice in Belarus (ALICIA(BY))

Observational Prospective Study of Acalabrutinib in Chronic Lymphocytic Leukemia 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

Study Overview

• Status: Recruiting
• Conditions: Chronic Lymphocytic Leukemia

Detailed Description

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.

• Study Type: Observational
• Enrollment (Estimated): 50

Contacts and Locations

• Study Contact: Name: AstraZeneca Clinical Study Information Center; Phone Number: 1-877-240-9479; Email: information.center@astrazeneca.com

Study Locations

• Belarus
  • Minsk, Belarus
    • Recruiting
    • Research Site

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Adult; Older Adult
• Accepts Healthy Volunteers: No

• Sampling Method: Non-Probability Sample

Study Population

The study population comprises adult patients (≥18 years old) diagnosed with CLL, who have been newly prescribed acalabrutinib monotherapy within four weeks prior to study enrolment. This includes both treatment-naïve patients and patients with relapsed/refractory (R/R) CLL.

Description

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

Study Plan

How is the study designed?

Number of groups / cohorts

1

Cohorts and Interventions

Group / Cohort
patients with CLL; no control group or comparator involved

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Time to treatment discontinuation	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	up to 25 months

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Reasons for treatment discontinuation	Collected from source medical documents (e.g., progression, toxicity, patient preference, physician's decision).	up to 25 months
Rates for dose modifications	numerical count of dose reductions or holds, and categorization of underlying reasons (e.g., toxicity, drug interactions, comorbidities), derived from medical records	up to 25 months
reasons for dose modifications	numerical count of dose reductions or holds, and categorization of underlying reasons (e.g., toxicity, drug interactions, comorbidities), derived from medical records	up to 25 months
Subsequent treatments	qualitative categorical descriptions of therapies following acalabrutinib discontinuation	up to 25 months
Treatment interruptions	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	up to 25 months

Other Outcome Measures

Outcome Measure	Measure Description	Time Frame
PFS measures, including one- and two-year rates	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.	up to 25 months
OS rates	OS rates at one and two years of follow-up defined as proportion of alive participants at the given timepoint	up to 25 months

Collaborators and Investigators

• Sponsor: AstraZeneca

Study record dates

Study Major Dates

• Study Start (Actual): December 31, 2025
• Primary Completion (Estimated): December 31, 2029
• Study Completion (Estimated): December 31, 2029

Study Registration Dates

• First Submitted: November 17, 2025
• First Submitted That Met QC Criteria: December 3, 2025
• First Posted (Actual): December 17, 2025

Study Record Updates

• Last Update Posted (Actual): April 17, 2026
• Last Update Submitted That Met QC Criteria: April 16, 2026
• Last Verified: April 1, 2026

More Information

Terms related to this study

• Keywords: CLL
• Additional Relevant MeSH Terms: Pathologic Processes; Neoplasms; Chronic Disease; Disease Attributes; Immune System Diseases; Neoplasms by Histologic Type; Hematologic Diseases; Lymphatic Diseases; Lymphoproliferative Disorders; Immunoproliferative Disorders; Leukemia, B-Cell; Leukemia, Lymphoid; Leukemia; Pathological Conditions, Signs and Symptoms; Hemic and Lymphatic Diseases; Leukemia, Lymphocytic, Chronic, B-Cell
• Other Study ID Numbers: D8220R00090

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: YES

IPD Plan Description

Qualified researchers can request access to anonymized individual patient-level data from AstraZeneca group of companies sponsored clinical trials via the request portal Vivli.org. All requests will be evaluated as per the AZ disclosure commitment: https://astrazenecagrouptrials.pharmacm.com/ST/Submission/Disclosure.

Yes, indicates that AZ are accepting requests for IPD, but this does not mean all requests will be shared.

• IPD Sharing Time Frame: AstraZeneca will meet or exceed data availability as per the commitments made to the EFPIA PhRMA Data Sharing Principles. For details of our timelines, please rerefer to our disclosure commitment at https://astrazenecagrouptrials.pharmacm.com/ST/Submission/Disclosure.
• IPD Sharing Access Criteria: When a request has been approved AstraZeneca will provide access to the anonymized individual patient-level data via secure research environment Vivli.org. Signed Data Usage Agreement (non-negotiable contract for data accessors) must be in place before accessing requested information.
• IPD Sharing Supporting Information Type: ICF; CSR

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No