Leukemia, Chronic LymphaticFABRICNCT04407845
Atrial Fibrillation in Patients Receiving Ibrutinib
An observational study of Leukemia, Chronic Lymphatic and Mantle Cell Lymphoma, run by European Georges Pompidou Hospital at 1 site in France.
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. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Leukemia, Chronic Lymphatic, Mantle Cell Lymphoma
- How many people
- 60 participants
- Where
- 1 siteFrance
- Study dates
- 21 May 2020to 30 Nov 2022
- Phase
- Observational
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Study population: Prospective consecutive cohort
Who may be able to join
- All patients deem to start ibrutinib therapy
Who cannot join
- Past history of ibrutinib therapy
Trial locations and contacts
1 site in 1 country.
France1 site, 1 recruiting
- Recruiting
Assistance Publique Hôpitaux de Paris - Centre Université de Paris
Paris, 75015
Mariana Mirabel, MD, PhD, +33156095636, mariana.mirabel@aphp.fr
About this study
Official title: Etude de l'Incidence et Des Facteurs prédictifs de la Survenue de Fibrillation Atriale Sous Ibrutinib
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.
- Conditions
- Leukemia, Chronic Lymphatic, Mantle Cell Lymphoma
- Keywords
- atrial fibrillation, haematology, systemic hypertension, prognosis, heart
- Medical subject headings
- Leukemia, Lymphocytic, Chronic, B-Cell, Lymphoma, Mantle-Cell, Atrial Fibrillation, Hypertension
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: 6 months
Secondary outcomes (6)
Incidence of supra-ventricular arrythmias
Number of patients with supra-ventricular arrythmias
Measured: 6 months
Incidence of systemic hypertension
Number of patients with systemic hypertension
Measured: 6 months
Incidence of arterial embolism
Number of patients with systemic hypertension
Measured: 6 months
Incidence of hemorraghe
Number of patients with hemorraghe
Measured: 6 months
Safety mesures
Compare advsere events in patients with supr-ventricular arrhythmias according to the continuation or discontinuation of ibrutinib
Measured: 1 year
Anticoagulants
Correlation between anti thrombotic strategies and cardiovascular outcomes
Measured: 1 year
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted29 May 2020
- Study start21 May 2020
- Primary completion21 May 2022 (estimated)
- Study completion30 Nov 2022 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Leukemia, Chronic LymphaticStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Cohort
- Time perspective
- Prospective
- Enrolment
- 60 participants (estimated)
Sponsor and investigators
- Lead sponsor
- European Georges Pompidou Hospital
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Mariana Mirabel, European Georges Pompidou Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04407845
- Sponsor's protocol ID
- 00011928 FABRIC
- Acronym
- FABRIC
- Status last verified
- Jun 2020
- First submitted
- 14 May 2020
- Last updated
- 9 Jun 2020
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Undecided
Study at a glance
From the registry record, last updated by the sponsor on 9 Jun 2020. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Etude de l'Incidence et Des Facteurs prédictifs de la Survenue de Fibrillation Atriale Sous Ibrutinib
- ClinicalTrials.gov ID
- NCT04407845
- Acronym / sponsor ID
- FABRIC / 00011928 FABRIC
- Conditions
- Leukemia, Chronic Lymphatic, Mantle Cell Lymphoma
- Keywords
- atrial fibrillation, haematology, systemic hypertension, prognosis, heart
- Study type
- Observational
- Recruitment status
- Unknown status
- Enrolment
- 60 participants (estimated)
- Lead sponsor
- European Georges Pompidou HospitalUniversity, hospital or other
- Study start
- 21 May 2020 (actual)
- Primary completion
- 21 May 2022 (estimated)
- Study completion
- 30 Nov 2022 (estimated)
- First posted
- 29 May 2020 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- Prospective consecutive cohort
Key inclusion criteria (1 listed)
- All patients deem to start ibrutinib therapy
Key exclusion criteria (1 listed)
- Past history of ibrutinib therapy
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Primary outcome
Incidence of cardiovascular events on ibrutinib
Time frame: 6 months
Evaluate the incidence of cardiotoxicity (composite endpoint) in a cohort of patients referred to a cardio-oncology before initiation of ibrutinib.
6 secondary outcomes
Incidence of supra-ventricular arrythmias
Time frame: 6 months
Incidence of systemic hypertension
Time frame: 6 months
Incidence of arterial embolism
Time frame: 6 months
Incidence of hemorraghe
Time frame: 6 months
Safety mesures
Time frame: 1 year
Anticoagulants
Time frame: 1 year
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 9 Jun 2020.
- Individual participant dataSharing planned: Undecided
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Leukemia, Chronic Lymphatic and Mantle Cell Lymphoma, run by European Georges Pompidou Hospital at 1 site in France.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 1 inclusion and 1 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: status not confirmed, as of the sponsor's last update on 9 Jun 2020. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in France. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Mariana Mirabel, MD, PHD (+33156095636, mariana.mirabel@aphp.fr), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Incidence of cardiovascular events on ibrutinib (time frame: 6 months). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 9 Jun 2020.