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

N/ANot Yet RecruitingNCT07288515

AstraZeneca50 enrolled

Overview

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

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

Conditions

Chronic Lymphocytic Leukemia

Eligibility

Sex: ALLMin age: 18 Years

Medical Language ↔ Plain English

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

Outcomes

Primary Outcomes

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

Time frame: up to 25 months

Secondary Outcomes

Reasons for treatment discontinuation

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

Time frame: 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

Time frame: 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

Time frame: up to 25 months

Subsequent treatments

qualitative categorical descriptions of therapies following acalabrutinib discontinuation

Time frame: 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

Time frame: up to 25 months

Central Contacts

AstraZeneca Clinical Study Information Center

CONTACT

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

Data from ClinicalTrials.gov

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