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

NCT07174141 | Recruiting

• 1 other identifier: ROBERT_AOI_2022
• Study Type: observational
• Target: 100
• Locations: 1 country
• Sites: 1

Brief Summary

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.

Conditions

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

Outcome Measures

Primary Outcomes (1)

• Number of participants with a diagnosis of new-onset high blood pressure or worsening of pre-existing hypertension

  12 months after initiation of treatment with second-generation Bruton's tyrosine kinase inhibitors in hematology

Study Arms (1)

Patients

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

Other: Ophthalmological examination; Biological: Blood sample

Interventions

Ophthalmological examination OTHER

at inclusion, at 3 months and 6 months; OCT-A retina

Patients

Blood sample BIOLOGICAL

Collection of a 2 mL blood sample at inclusion

Patients

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)
• Sampling Method: Non-Probability Sample

Study Population

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

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• Centre Hospitalier Universitaire Dijon: lead

Study Sites (1)

CHU Dijon Bourgogne

Dijon, France

RECRUITING

MeSH Terms

Interventions

Blood Specimen Collection

Intervention Hierarchy (Ancestors)

Specimen Handling; Clinical Laboratory Techniques; Diagnostic Techniques and Procedures; Diagnosis; Punctures; Surgical Procedures, Operative; Investigative Techniques

Central Study Contacts

Romain DIDIER

CONTACT

0380293031; romain.didier@chu-dijon.fr

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: PROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: September 4, 2025
• First Posted: September 15, 2025
• Study Start: November 28, 2025
• Primary Completion (Estimated): November 1, 2028
• Study Completion (Estimated): November 1, 2028
• Last Updated: December 4, 2025

Record last verified: 2025-12

Locations

FR (1)