NCT04407845

Brief 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.

Trial Health

43
At Risk

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Trial has exceeded expected completion date
Enrollment
60

participants targeted

Target at P25-P50 for all trials

Timeline
Completed

Started May 2020

Typical duration for all trials

Geographic Reach
1 country

1 active site

Status
unknown

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

May 14, 2020

Completed
7 days until next milestone

Study Start

First participant enrolled

May 21, 2020

Completed
8 days until next milestone

First Posted

Study publicly available on registry

May 29, 2020

Completed
2 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

May 21, 2022

Completed
6 months until next milestone

Study Completion

Last participant's last visit for all outcomes

November 30, 2022

Completed
Last Updated

June 9, 2020

Status Verified

June 1, 2020

Enrollment Period

2 years

First QC Date

May 14, 2020

Last Update Submit

June 4, 2020

Conditions

Leukemia, Chronic LymphaticMantle Cell Lymphoma

Keywords

atrial fibrillationhaematologysystemic hypertensionprognosisheart

Outcome Measures

Primary Outcomes (1)

  • 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 Outcomes (6)

  • Incidence of supra-ventricular arrythmias

    6 months

  • Incidence of systemic hypertension

    6 months

  • Incidence of arterial embolism

    6 months

  • Incidence of hemorraghe

    6 months

  • Safety mesures

    1 year

  • +1 more secondary outcomes

Eligibility Criteria

Age18 Years+
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)
Sampling MethodNon-Probability Sample
Study Population

Prospective consecutive cohort

You may qualify if:

  • All patients deem to start ibrutinib therapy

You may not qualify if:

  • Past history of ibrutinib therapy

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Assistance Publique Hôpitaux de Paris - Centre Université de Paris

Paris, 75015, France

RECRUITING

MeSH Terms

Conditions

Leukemia, Lymphocytic, Chronic, B-CellLymphoma, Mantle-CellAtrial FibrillationHypertension

Condition Hierarchy (Ancestors)

Leukemia, B-CellLeukemia, LymphoidLeukemiaNeoplasms by Histologic TypeNeoplasmsHematologic DiseasesHemic and Lymphatic DiseasesLymphoproliferative DisordersLymphatic DiseasesImmunoproliferative DisordersImmune System DiseasesChronic DiseaseDisease AttributesPathologic ProcessesPathological Conditions, Signs and SymptomsLymphoma, Non-HodgkinLymphomaArrhythmias, CardiacHeart DiseasesCardiovascular DiseasesVascular Diseases

Central Study Contacts

Mariana Mirabel, MD, PHD

CONTACT

+33156095636mariana.mirabel@aphp.fr

Study Design

Study Type
observational
Observational Model
COHORT
Time Perspective
PROSPECTIVE
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
MD, PhD, Associate Professor

Study Record Dates

First Submitted

May 14, 2020

First Posted

May 29, 2020

Study Start

May 21, 2020

Primary Completion

May 21, 2022

Study Completion

November 30, 2022

Last Updated

June 9, 2020

Record last verified: 2020-06

Locations

FR(1)