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Innovative Biomarkers of Cardiovascular Complications Associated With Second-generation Bruton Tyrosine Kinase Inhibitor Treatments: a Single-center Cohort Study

Recruitingn/aAges 18 Years - anyAllCentre Hospitalier Universitaire Dijon
NCT07174141 on ClinicalTrials.gov ↗
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In plain words

What the trial is, and whether it could suit you

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 iden

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📋 Eligibility rules (as published)
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
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What it tests

  • Ophthalmological examination
  • Blood sample
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Where

1 site
CHU Dijon Bourgogne
Dijon, France
🤝 Taking part is your choice, and you can leave at any time. Only the trial team can confirm you are eligible — always decide together with your own doctor.
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