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Cardiovascular Complications of Ibrutinib Therapy

NCT ID: NCT05939752

Last Updated: 2023-12-29

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

RECRUITING

Total Enrollment

100 participants

Study Classification

OBSERVATIONAL

Study Start Date

2023-12-20

Study Completion Date

2027-03-31

Brief Summary

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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

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Conditions

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Ibrutinib Treatment

Study Design

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Observational Model Type

COHORT

Study Time Perspective

PROSPECTIVE

Study Groups

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patient

Patients with an indication for ibrutinib treatment for hematologic reasons

ophthalmological examination

Intervention Type OTHER

OCT-retinal angiography At inclusion, 3 months and 6 months

blood test

Intervention Type BIOLOGICAL

a 2-mL tube of blood will be taken to test for blood markers predisposing to cardiovascular complications.

At inclusion

Interventions

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ophthalmological examination

OCT-retinal angiography At inclusion, 3 months and 6 months

Intervention Type OTHER

blood test

a 2-mL tube of blood will be taken to test for blood markers predisposing to cardiovascular complications.

At inclusion

Intervention Type BIOLOGICAL

Eligibility Criteria

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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
Minimum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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Centre Hospitalier Universitaire Dijon

OTHER

Sponsor Role lead

Responsible Party

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Responsibility Role SPONSOR

Locations

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Chu Dijon Bourgogne

Dijon, , France

Site Status RECRUITING

Countries

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France

Central Contacts

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Romain DIDIER

Role: CONTACT

Phone: 03.80.29.30.31

Email: [email protected]

Facility Contacts

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Romain DIDIER

Role: primary

Other Identifiers

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ROBERT AOI 2022

Identifier Type: -

Identifier Source: org_study_id