Innovative Biomarkers of Cardiovascular Complications Associated With Second-generation Bruton Tyrosine Kinase Inhibitor Treatments: a Single-center Cohort Study
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
- The protocol lists: Ophthalmological examination, Blood sample.
- Who it may be relevant to
- Registry conditions: Treatment With Second-generation Bruton's Tyrosine Kinase Inhibitors (Acalabrutinib, Zanubrutinib). 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
- France
- 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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Overview
Second-generation Bruton's tyrosine kinase inhibitors (BTKIs) (zanubrutinib, acalabrutinib) are recently discovered oral targeted therapies used to treat hematological disorders such as chronic lymphocytic leukemia, mantle cell lymphoma, non-Hodgkin's lymphoma, and Waldenström's macroglobulinemia. These treatments significantly increase survival rates for these diseases, but over the years, we have observed the emergence of cardiovascular adverse effects such as cardiac arrhythmia and high blood pressure, the type and frequency of which differ from those of first-generation drugs such as ibrutinib. The frequency of these cardiovascular events remains poorly understood, as do the risk factors for developing these complications. The aim of this study is to determine the exact incidence of cardiac arrhythmia and high blood pressure in patients receiving second-generation IBTK and to identify risk factors that can predict these complications through close, specialized monitoring. Ultimately, this will make it possible to better target patients at highest risk of developing cardiovascular complications and offer them appropriate follow-up care. This is a single-center, prospective, observational study conducted at the Dijon Bourgogne University Hospital. The required number of subjects is 100 patients. The total follow-up period for each patient is one year.
Interventions
- Other Ophthalmological examination
at inclusion, at 3 months and 6 months; OCT-A retina - Biological Blood sample
Collection of a 2 mL blood sample at inclusion
Primary outcome measures
- Number of participants with a diagnosis of new-onset high blood pressure or worsening of pre-existing hypertension [Time frame: 12 months after initiation of treatment with second-generation Bruton's tyrosine kinase inhibitors in hematology]
Eligibility criteria
Inclusion criteria
- Patients eligible for treatment with second-generation Bruton's tyrosine kinase inhibitors in hematology (acalabrutinib, zanubrutinib)
- Patients aged 18 years and older
- Patients who have given their free and informed written consent to participate in this study after receiving information (or the patient's representative if the patient is unable to express consent themselves).
- Patients with a life expectancy estimated by the hematologist in charge of the patient to be greater than one year
Exclusion criteria
- Persons not affiliated with or not covered by a social security system
- Patients subject to legal protection measures (guardianship, trusteeship)
- Patients subject to judicial protection measures
- Pregnant women, women in labor, or breastfeeding women
- Prior treatment with Bruton's tyrosine kinase inhibitors (ibrutinib, acalabrutinib, zanubrutinib)
- Follow-up planned at another center
- History of atrial fibrillation
- Uncontrolled hypertension
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
France · 1 center
- CHU Dijon Bourgogne — Dijon
Identifiers
NCT: NCT07174141 · ROBERT_AOI_2022