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

NCT07288515 | Recruiting

• 1 other identifier: D8220R00090
• Study Type: observational
• Target: 50
• Locations: 1 country
• Sites: 3

Brief Summary

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

Conditions

Chronic Lymphocytic Leukemia

Keywords

CLL

Outcome Measures

Primary Outcomes (1)

• Time to treatment discontinuation

  defined as the duration (in days) from the initiation of acalabrutinib therapy until the earliest of: 1. documented permanent treatment discontinuation as recorded in the patient's medical chart, or 2. death from any cause

  up to 25 months

Secondary Outcomes (5)

• Reasons for treatment discontinuation

  up to 25 months

• Rates for dose modifications

  up to 25 months

• reasons for dose modifications

  up to 25 months

• Subsequent treatments

  up to 25 months

• Treatment interruptions

  up to 25 months

Other Outcomes (2)

• PFS measures, including one- and two-year rates

  up to 25 months

• OS rates

  up to 25 months

Study Arms (1)

patients with CLL

no control group or comparator involved

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)
• 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.

You may qualify if:

• 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.

You may not qualify if:

• Prior treatment with any BTK inhibitor.
• Participation in other ongoing clinical trials.
• Pregnant or breastfeeding females

Sponsors & Collaborators

• AstraZeneca: lead

Study Sites (3)

Research Site

Grodno, Belarus

NOT YET RECRUITING

Research Site

Homyel, Belarus

NOT YET RECRUITING

Research Site

Minsk, Belarus

RECRUITING

MeSH Terms

Conditions

Leukemia, Lymphocytic, Chronic, B-Cell

Condition Hierarchy (Ancestors)

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

Central Study Contacts

AstraZeneca Clinical Study Information Center

CONTACT

1-877-240-9479; information.center@astrazeneca.com

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: PROSPECTIVE
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: November 17, 2025
• First Posted: December 17, 2025
• Study Start: December 31, 2025
• Primary Completion (Estimated): December 31, 2029
• Study Completion (Estimated): December 31, 2029
• Last Updated: July 16, 2026

Record last verified: 2026-07

Data Sharing

• IPD Sharing: Will share
• Shared Documents: ICF, CSR
• 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.
• 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.

Locations

BE (3)