Atrial Fibrillation in Patients Receiving Ibrutinib

Mantle Cell Lymphoma Clinical Trial

— FABRIC  

Official title:

Etude de l'Incidence et Des Facteurs prédictifs de la Survenue de Fibrillation Atriale Sous Ibrutinib

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT04407845
• Other study ID #: 00011928 FABRIC
• Status: Recruiting
• Start date: May 21, 2020
• Est. completion date: November 30, 2022

Study information

• Verified date: June 2020
• Source: European Georges Pompidou Hospital
• Contact: Mariana Mirabel, MD, PHD
• Phone: +33156095636
• Email: mariana.mirabel[@]aphp.fr
• Is FDA regulated: No
• Study type: Observational

Clinical Trial Summary

Ibrutinib (a tyrosine kinase inhibitor targeting Bruton) is a standard of treatment in haematology. According to retrospective data, atrial fibrillation and systemic hypertension are common ibrutinib-related advserse events. The investigators aim at prospectively establishing the incidence of thesedrug related advsere events through clinical monitoring and attempt at identifying populations at risk.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 60
• Est. completion date: November 30, 2022
• Est. primary completion date: May 21, 2022
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

Inclusion Criteria:

• All patients deem to start ibrutinib therapy

Exclusion Criteria:

• Past history of ibrutinib therapy

Related Conditions & MeSH terms

• Leukemia, Chronic Lymphatic
• Leukemia, Lymphocytic, Chronic, B-Cell
• Lymphoma, Mantle-Cell
• Mantle Cell Lymphoma

Locations

Country	Name	City	State
France	Assistance Publique Hôpitaux de Paris - Centre Université de Paris	Paris

Sponsors (1)

Lead Sponsor	Collaborator
European Georges Pompidou Hospital

Country where clinical trial is conducted

France, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Incidence of cardiovascular events on ibrutinib	Evaluate the incidence of cardiotoxicity (composite endpoint) in a cohort of patients referred to a cardio-oncology before initiation of ibrutinib.	6 months
Secondary	Incidence of supra-ventricular arrythmias	Number of patients with supra-ventricular arrythmias	6 months
Secondary	Incidence of systemic hypertension	Number of patients with systemic hypertension	6 months
Secondary	Incidence of arterial embolism	Number of patients with systemic hypertension	6 months
Secondary	Incidence of hemorraghe	Number of patients with hemorraghe	6 months
Secondary	Safety mesures	Compare advsere events in patients with supr-ventricular arrhythmias according to the continuation or discontinuation of ibrutinib	1 year
Secondary	Anticoagulants	Correlation between anti thrombotic strategies and cardiovascular outcomes	1 year