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

University Hospital Center (CHU) Dijon Bourgogne

Status: Enrolling

Conditions: Treatment With Second-generation Bruton's Tyrosine Kinase Inhibitors (Acalabrutinib, Zanubrutinib)

Treatments: Biological: Blood sample; Other: Ophthalmological examination

Study type: Observational

Funder types: Other

Identifiers

NCT07174141

ROBERT_AOI_2022

Details and patient eligibility

About

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.

Enrollment: 100 estimated patients

Sex: All

Ages: 18+ years old

Volunteers: No Healthy Volunteers

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

Trial design

100 participants in 1 patient group

Patients

Description:

Patients eligible for treatment with second-generation Bruton's tyrosine kinase inhibitors in hematology (acalabrutinib, zanubrutinib)

Treatment:

Other: Ophthalmological examination

Biological: Blood sample