Ibrutinib TreatmentCACISNCT05939752
Cardiovascular Complications of Ibrutinib Therapy
An observational study of Ibrutinib Treatment, run by Centre Hospitalier Universitaire Dijon at 1 site in France.
Trial 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). Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Ibrutinib Treatment
- What is being tested?
- ophthalmological examination and blood test
- How many people
- 8 participants
- Where
- 1 siteFrance
- Study dates
- 20 Dec 2023to 5 Aug 2025
- 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: Eligible patients will be identified by a doctor working in the hematology department of Dijon University Hospital during his or her regular medical check-up.
Who may be able to join
- 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).
Who cannot join
- 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
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Cardiovascular Complications of Ibrutinib Therapy: a Single-center Cohort Study
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.
- Conditions
- Ibrutinib Treatment
- Being tested
- ophthalmological examination, blood test
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
ophthalmological examinationOther
OCT-retinal angiography At inclusion, 3 months and 6 months
blood testBiological
a 2-mL tube of blood will be taken to test for blood markers predisposing to cardiovascular complications.
At inclusion
| Study group | Role | What they receive |
|---|---|---|
| patient | Patients with an indication for ibrutinib treatment for hematologic reasons Receives: Other: ophthalmological examination; Biological: blood test |
What is being measured
The primary outcome is the main question the study is designed to answer.
rate of patients developing atrial fibrillation (AF)
Compare the values of selected biomarkers between patients who have developed AF and patients without AF
Measured: 12 months after introduction of ibrutinib
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted11 Jul 2023
- Study start20 Dec 2023
- Primary completion5 Aug 2025
- Study completion5 Aug 2025
Why it stopped: premature shutdown due to change in processing line
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Ibrutinib TreatmentStudies of the same condition, open and under way.
- More trials run by Centre Hospitalier Universitaire DijonThe sponsor's other registered studies.
- 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
- 8 participants (actual)
Sponsor and investigators
- Lead sponsor
- Centre Hospitalier Universitaire Dijon
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05939752
- Sponsor's protocol ID
- ROBERT AOI 2022
- Acronym
- CACIS
- Status last verified
- Feb 2026
- First submitted
- 3 Jul 2023
- Last updated
- 27 Feb 2026
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 27 Feb 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Cardiovascular Complications of Ibrutinib Therapy: a Single-center Cohort Study
- ClinicalTrials.gov ID
- NCT05939752
- Acronym / sponsor ID
- CACIS / ROBERT AOI 2022
- Conditions
- Ibrutinib Treatment
- Study type
- Observational
- Recruitment status
- TerminatedReason stopped: premature shutdown due to change in processing line
- Enrolment
- 8 participants (actual)
- Lead sponsor
- Centre Hospitalier Universitaire DijonUniversity, hospital or other
- Study start
- 20 Dec 2023 (actual)
- Primary completion
- 5 Aug 2025 (actual)
- Study completion
- 5 Aug 2025 (actual)
- First posted
- 11 Jul 2023 (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, 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.
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| patient | – | Other: ophthalmological examination, Biological: blood testPatients with an indication for ibrutinib treatment for hematologic reasons |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- Eligible patients will be identified by a doctor working in the hematology department of Dijon University Hospital during his or her regular medical check-up.
Key inclusion criteria (3 listed)
- 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).
Key exclusion criteria (7 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| ophthalmological examinationOCT-retinal angiography At inclusion, 3 months and 6 months | Other | patient |
| blood testa 2-mL tube of blood will be taken to test for blood markers predisposing to cardiovascular complications. At inclusion | Biological | patient |
Primary outcome
rate of patients developing atrial fibrillation (AF)
Time frame: 12 months after introduction of ibrutinib
Compare the values of selected biomarkers between patients who have developed AF and patients without AF
Results and safety
The study was stopped early (reason given: premature shutdown due to change in processing line). Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 27 Feb 2026.
Related trials for Ibrutinib Treatment
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Not yet recruitingPhase 2
Epcoritamab as Consolidative Therapy for Waldenstr(SqrRoot)(Delta)m Macroglobulinemia (WM) Treated With a Bruton Tyrosine Kinase Inhibitor (BTKi)
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Active, not recruitingPhase 3
A Study of the Combination of Ibrutinib Plus Venetoclax Versus Chlorambucil Plus Obinutuzumab for the First-line Treatment of Participants With Chronic Lymphocytic Leukemia (CLL)/Small Lymphocytic Lymphoma (SLL)
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Active, not recruitingPhase 2
A Study to Customize Ibrutinib Treatment Regimens for Participants With Previously Untreated Chronic Lymphocytic Leukemia
Leukemia, Lymphocytic, Chronic, B-Cell, Small Lymphocytic Lymphoma
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.
The record lists no contact. Use the official record to reach the sponsor.
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 Ibrutinib Treatment, run by Centre Hospitalier Universitaire Dijon 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 3 inclusion and 7 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: stopped early, as of the sponsor's last update on 27 Feb 2026. 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?
The study was stopped early (reason given: premature shutdown due to change in processing line). Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
rate of patients developing atrial fibrillation (AF) (time frame: 12 months after introduction of ibrutinib). 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 27 Feb 2026.