Cardiovascular Complications of Ibrutinib Therapy

Recruiting

• Conditions: Ibrutinib Treatment
• Interventions: Other: ophthalmological examination; Biological: blood test

• Registration Number: NCT05939752
• Lead Sponsor: Centre Hospitalier Universitaire Dijon

Brief Summary

Ibrutinib, the first BTK inhibitor (BTKI) to be approved, improves progression-free survival (PFS) and overall survival (OS) over alternative therapies in relapsed/refractory and treatment-naive chronic lymphocytic leukemia (CLL). Ibrutinib has also been found to be effective in mantle cell lymphoma, Waldenström's macroglobulinemia and marginal zone lymphoma. However, ibrutinib treatment is associated with an increased risk of atrial fibrillation (AF), with an estimated 2-year AF rate of 16% in patients treated with ibrutinib during a median follow-up of 28 months. In most studies, AF was identified by reports as a treatment-related adverse event, and systematic screening for AF was not performed. As AF is often paroxysmal, the more intensive the screening, the higher the incidence. In a prospective cohort study of 53 patients treated with ibrutinib for CLL, patients were monitored by pulse palpation and ECG every 3 months. The cumulative incidence rate of ibrutinib-associated AF was 23% at 12 months and 38% at 2 years. The management of ibrutinib-associated AF is challenging due to difficulties in balancing the benefits of anticoagulation to mitigate the risk of stroke and the bleeding risk associated with ibrutinib. AF is a frequent reason for discontinuation of ibrutinib therapy, and can result in significant morbidity.

In addition to this arrhythmogenic effect, ibrutinib is also significantly associated with the onset or worsening of arterial hypertension. Finally, an increased risk of serious ventricular rhythm disorders has also been suggested by pharmacovigilance databases, but not yet confirmed by prospective clinical studies.

The study proposes a comprehensive cardiovascular approach, at baseline and during follow-up of patients on Ibrutinib, using innovative markers to anticipate patients most at risk of developing these cardiovascular effects, but also to detect them as early as possible in order to avoid the complications they may generate.

Detailed Description

Not available

Study Timeline

• Study First Submitted: 2023-07-03
• Study First Submitted QC: 2023-07-03
• Study First Posted: 2023-07-11
• Status Verified: 2023-12
• Study Start: 2023-12-20
• Last Update Submitted: 2023-12-22
• Last Update Posted: 2023-12-29
• Primary Completion: 2027-03
• Study Completion: 2027-03

Recruitment & Eligibility

• Status: RECRUITING
• Sex: All
• Target Recruitment: 100

Inclusion Criteria

• Patients with an indication for ibrutinib treatment for hematologic reasons
• Patients aged 18 and over
• Patients who have given their free, written and informed consent to this study after being informed (or by the patient's representative if the patient is unable to express his or her consent).

Exclusion Criteria

• Person not affiliated to national health insurance
• Patient under legal protection (curatorship, guardianship)
• Patient subject to a safeguard of justice measure
• Pregnant, parturient or breast-feeding women
• Previous treatment with ibrutinib
• Follow-up planned in another center
• History of atrial fibrillation

Study & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Arm && Interventions

Group	Intervention	Description
patient	ophthalmological examination	Patients with an indication for ibrutinib treatment for hematologic reasons
patient	blood test	Patients with an indication for ibrutinib treatment for hematologic reasons

Primary Outcome Measures

Name	Time	Method
rate of patients developing atrial fibrillation (AF)	12 months after introduction of ibrutinib	Compare the values of selected biomarkers between patients who have developed AF and patients without AF

Trial Locations

Locations (1)

Chu Dijon Bourgogne; 🇫🇷 Dijon, France