Observ Prosp Study of Acalabrutinib in CLL Therapy in Real Clinical Practice in Belarus
For patients and families
In plain language
An automatic summary of structured registry data. It is an orientation aid, not a substitute for the official protocol or a physician assessment.
- What is being studied
- This is an observational study: the protocol does not assign a study treatment.
- Who it may be relevant to
- Registry conditions: Chronic Lymphocytic Leukemia. Basic parameters: from 18 years · All.
- What needs checking
- Age, condition and sex are only basic indicators. Prior treatment, laboratory values and other mandatory requirements appear in the eligibility criteria below.
- Where it takes place
- Belarus
- Next step
- Save the trial, show it to the treating physician, and confirm current recruitment with the study center. Costs, documents and travel →
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Official title
Observational Prospective Study of Acalabrutinib in Chronic Lymphocytic Leukemia Therapy in Real Clinical Practice in Belarus.
Overview
to address critical gap in knowledge, providing essential data on the real-world effectiveness, safety, associated with acalabrutinib treatment in patients with CLL
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.
Primary outcome measures
- Time to treatment discontinuation [Time frame: up to 25 months]
Secondary outcome measures (5)
- Reasons for treatment discontinuation [Time frame: up to 25 months]
- Rates for dose modifications [Time frame: up to 25 months]
- reasons for dose modifications [Time frame: up to 25 months]
- Subsequent treatments [Time frame: up to 25 months]
- Treatment interruptions [Time frame: up to 25 months]
Eligibility criteria
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
Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.
Healthy volunteers: No
Study design
- Observational model
- Cohort
Study locations
Belarus · 3 centers
- Research Site — Grodno
- Research Site — Homyel
- Research Site — Minsk
Identifiers
NCT: NCT07288515 · D8220R00090