Chronic Lymphocytic Leukemia
Conditions
Keywords
CLL
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
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.
Interventions
None listed
Sponsors
AstraZeneca
Study design
Observational model
COHORT
Time perspective
PROSPECTIVE
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No
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
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Time to treatment discontinuation | up to 25 months | 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 |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Reasons for treatment discontinuation | up to 25 months | Collected from source medical documents (e.g., progression, toxicity, patient preference, physician's decision). |
| Rates for dose modifications | 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 |
| reasons for dose modifications | 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 |
| Subsequent treatments | up to 25 months | qualitative categorical descriptions of therapies following acalabrutinib discontinuation |
| Treatment interruptions | 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 |
Countries
Belarus
Contacts
CONTACTAstraZeneca Clinical Study Information Center
Outcome results
None listed