Chronic B-cell MalignanciesNCT06561243
Ibrutinib and Acalabrutinib Use and Risk of Atrial Fibrillation in Patients With Chronic B-cell Malignancies
An observational study of Chronic B-cell Malignancies and BTK Inhibitors, run by University Hospital, Caen at 1 site in France.
Trial summary
Background. Ibrutinib and acalabrutinib are both associated with an increased risk of atrial fibrillation (AF) but AF comparative risk between these 2 BTK inhibitors (BTKis) remains largely unknown. Objectives. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Chronic B-cell Malignancies, BTK Inhibitors, Cardiovascular Diseases
- What is being tested?
- BTK inhibitor (Ibrutinib or Acalabrutinib)
- How many people
- 15,000 participants
- Where
- 1 siteFrance
- Study dates
- 25 Jul 2024to 30 Oct 2024
- 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
- Adult, Older adult
Study population: adult patients - diagnose with chronic B-cell malignancies expose to ibrutinib or acalabrutinib in the TrinetX database
Who may be able to join
- adult patients
- diagnose with chronic B-cell malignancies using ICD-10-CM codes C91 (lymphoid leukemia), C88.0 (Waldenström macroglobulinemia), C83.1 (mantle cell lymphoma), C81-C96 (malignant neoplasms of lymphoid, hematopoietic and related tissue) or C95 (leukemia of unspecified cell type)
- expose to ibrutinib or acalabrutinib determined by the Anatomical Therapeutic Chemical codes
Who cannot join
- -
Trial locations and contacts
1 site in 1 country.
France1 site
Caen University Hospital, Department of Pharmacology
Caen, Normandy
About this study
Background. Ibrutinib and acalabrutinib are both associated with an increased risk of atrial fibrillation (AF) but AF comparative risk between these 2 BTK inhibitors (BTKis) remains largely unknown.
Objectives. Our aim was to examine the risk of developing incident AF with ibrutinib exposure compared with acalabrutinib exposure.
Methods. Using the TriNetX research network database, authors will conduct a retrospective cohort analysis of deidentified, aggregate adult patients with chronic B-cell malignancies and exposed to ibrutinib or acalabrutinib. Patients will be divided into 2 groups based on ibrutinib or acalabrutinib exposure. After propensity score matching (PSM), hazard ratios (HRs) and their associated 95% confidence intervals (CIs) will be used to compare AF risk during follow-up between the matched 2 groups.
- Being tested
- BTK inhibitor (Ibrutinib or Acalabrutinib)
- Medical subject headings
- Cardiovascular Diseases
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
BTK inhibitor (Ibrutinib or Acalabrutinib)Drug
Adult patients with a chronic B-cell malignancy included in this study will be separate into 2 groups according to the BTK inhibitor (ibrutinib and acalabrutinib)
| Study group | Role | What they receive |
|---|---|---|
| Ibrutinib | Adult patients with a chronic B-cell malignancy exposed to ibrutinib Receives: Drug: BTK inhibitor (Ibrutinib or Acalabrutinib) | |
| Acalabrutinib | Adult patients with a chronic B-cell malignancy exposed to acalabrutinib Receives: Drug: BTK inhibitor (Ibrutinib or Acalabrutinib) |
What is being measured
The primary outcome is the main question the study is designed to answer.
Risk of incident atrial fibrillation in patients exposed to ibrutinib compared with those exposed to acalabrutinib in the whole matched cohort.
ICD-10-CM code I48 will be used to identify AF during follow-up
Measured: from the introduction of the BTK inhibitor and up to 120 months
Secondary outcomes (8)
Risk of incident atrial fibrillation in patients exposed to ibrutinib compared with those exposed to acalabrutinib in a matched cohort restricted to patients aged ≤75 and to patients aged >75
ICD-10-CM code I48 will be used to identify AF during follow-up
Measured: from the introduction of the BTK inhibitor and up to 120 months
Risk of incident atrial fibrillation in patients exposed to ibrutinib compared with those exposed to acalabrutinib in a matched cohort categorized according their baseline cardiovascular risk level for developing AF
ICD-10-CM code ill be used to identify AF during follow-up
Measured: from the introduction of the BTK inhibitor and up to 120 months
Risk of all-cause mortality in patients exposed to ibrutinib compared with those exposed to acalabrutinib in the whole matched cohort
death from any cause during follow-up
Measured: from the introduction of the BTK inhibitor and up to 120 months
Risk of incident intra-cerebral hemorrhage in patients exposed to ibrutinib compared with those exposed to acalabrutinib in the whole matched cohort
ICD-10-CM code ill be used to identify intra-cerebral hemorrhage during follow-up
Measured: from the introduction of the BTK inhibitor and up to 120 months
Risk of incident major bleeding in patients exposed to ibrutinib compared with those exposed to acalabrutinib in the whole matched cohort
ICD-10-CM code ill be used to identify major bleeding during follow-up
Measured: from the introduction of the BTK inhibitor and up to 120 months
Risk of incident hypertension in patients exposed to ibrutinib compared with those exposed to acalabrutinib in the whole matched cohort
ICD-10-CM code ill be used to identify hypertension during follow-up
Measured: from the introduction of the BTK inhibitor and up to 120 months
Risk of incident MACE (composite) in patients exposed to ibrutinib compared with those exposed to acalabrutinib in the whole matched cohort
ICD-10-CM code ill be used to identify MACE (composite of acute myocardial infraction, ischemic stroke or thromboembolism and heart failure) during follow-up
Measured: from the introduction of the BTK inhibitor and up to 120 months
Risk of incident ventricular tachycardia/ventricular fibrillation/cardiac arrest (composite) in patients exposed to ibrutinib compared with those exposed to acalabrutinib in the whole matched cohort
ICD-10-CM code ill be used to identify VT/VF/cardiac arrest (composite of ventricular tachycardia, ventricular fibrillation and cardiac arrest) during follow-up
Measured: from the introduction of the BTK inhibitor and up to 120 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted20 Aug 2024
- Study start25 Jul 2024
- Primary completion30 Sep 2024 (estimated)
- Study completion30 Oct 2024 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Chronic B-cell MalignanciesStudies of the same condition, open and under way.
- More trials run by University Hospital, CaenThe 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
- Retrospective
- Enrolment
- 15,000 participants (estimated)
Sponsor and investigators
- Lead sponsor
- University Hospital, Caen
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Joachim ALEXANDRE, University Hospital, Caen
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06561243
- Sponsor's protocol ID
- Pharmaco072424
- Status last verified
- Aug 2024
- First submitted
- 24 Jul 2024
- Last updated
- 21 Aug 2024
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- Yes
- FDA-regulated device
- No
- Individual data sharing
- No: Actually, data from TrinetX are only freely available for health care organizations participating to the health research network database.
Publications
Alexandre J, Font J, Lenormand T, Chantepie S, Bardet H, Damaj G, Dolladille C, Legallois D, Da-Silva A, Milliez P, Bisson A, Fauchier L. Ibrutinib and acalabrutinib use and risk of incident atrial fibrillation: a propensity-matched analysis. Exp Hematol Oncol. 2025 Mar 4;14(1):29. doi: 10.1186/s40164-025-00619-6.
PubMed 40038806
Study at a glance
From the registry record, last updated by the sponsor on 21 Aug 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Ibrutinib and Acalabrutinib Use and Risk of Atrial Fibrillation in Patients With Chronic B-cell Malignancies
- ClinicalTrials.gov ID
- NCT06561243
- Acronym / sponsor ID
- Pharmaco072424
- Study type
- Observational
- Recruitment status
- Unknown status
- Enrolment
- 15,000 participants (estimated)
- Lead sponsor
- University Hospital, CaenUniversity, hospital or other
- Study start
- 25 Jul 2024 (actual)
- Primary completion
- 30 Sep 2024 (estimated)
- Study completion
- 30 Oct 2024 (estimated)
- First posted
- 20 Aug 2024 (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.
Background. Ibrutinib and acalabrutinib are both associated with an increased risk of atrial fibrillation (AF) but AF comparative risk between these 2 BTK inhibitors (BTKis) remains largely unknown.
Objectives. Our aim was to examine the risk of developing incident AF with ibrutinib exposure compared with acalabrutinib exposure.
Methods. Using the TriNetX research network database, authors will conduct a retrospective cohort analysis of deidentified, aggregate adult patients with chronic B-cell malignancies and exposed to ibrutinib or acalabrutinib. Patients will be divided into 2 groups based on ibrutinib or acalabrutinib exposure. After propensity score matching (PSM), hazard ratios (HRs) and their associated 95% confidence intervals (CIs) will be used to compare AF risk during follow-up between the matched 2 groups.
Study design
- Observational model
- Cohort
- Time perspective
- Retrospective
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Ibrutinib | – | Drug: BTK inhibitor (Ibrutinib or Acalabrutinib)Adult patients with a chronic B-cell malignancy exposed to ibrutinib |
| Acalabrutinib | – | Drug: BTK inhibitor (Ibrutinib or Acalabrutinib)Adult patients with a chronic B-cell malignancy exposed to acalabrutinib |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Age groups
- Adult, Older adult
- Study population
- adult patients - diagnose with chronic B-cell malignancies expose to ibrutinib or acalabrutinib in the TrinetX database
Key inclusion criteria (3 listed)
- adult patients
- diagnose with chronic B-cell malignancies using ICD-10-CM codes C91 (lymphoid leukemia), C88.0 (Waldenström macroglobulinemia), C83.1 (mantle cell lymphoma), C81-C96 (malignant neoplasms of lymphoid, hematopoietic and related tissue) or C95 (leukemia of unspecified cell type)
- expose to ibrutinib or acalabrutinib determined by the Anatomical Therapeutic Chemical codes
Key exclusion criteria (1 listed)
- -
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 |
|---|---|---|
| BTK inhibitor (Ibrutinib or Acalabrutinib)Adult patients with a chronic B-cell malignancy included in this study will be separate into 2 groups according to the BTK inhibitor (ibrutinib and acalabrutinib) | Drug | Acalabrutinib, Ibrutinib |
Primary outcome
Risk of incident atrial fibrillation in patients exposed to ibrutinib compared with those exposed to acalabrutinib in the whole matched cohort.
Time frame: from the introduction of the BTK inhibitor and up to 120 months
ICD-10-CM code I48 will be used to identify AF during follow-up
8 secondary outcomes
Risk of incident atrial fibrillation in patients exposed to ibrutinib compared with those exposed to acalabrutinib in a matched cohort restricted to patients aged ≤75 and to patients aged >75
Time frame: from the introduction of the BTK inhibitor and up to 120 months
Risk of incident atrial fibrillation in patients exposed to ibrutinib compared with those exposed to acalabrutinib in a matched cohort categorized according their baseline cardiovascular risk level for developing AF
Time frame: from the introduction of the BTK inhibitor and up to 120 months
Risk of all-cause mortality in patients exposed to ibrutinib compared with those exposed to acalabrutinib in the whole matched cohort
Time frame: from the introduction of the BTK inhibitor and up to 120 months
Risk of incident intra-cerebral hemorrhage in patients exposed to ibrutinib compared with those exposed to acalabrutinib in the whole matched cohort
Time frame: from the introduction of the BTK inhibitor and up to 120 months
Risk of incident major bleeding in patients exposed to ibrutinib compared with those exposed to acalabrutinib in the whole matched cohort
Time frame: from the introduction of the BTK inhibitor and up to 120 months
Risk of incident hypertension in patients exposed to ibrutinib compared with those exposed to acalabrutinib in the whole matched cohort
Time frame: from the introduction of the BTK inhibitor and up to 120 months
Risk of incident MACE (composite) in patients exposed to ibrutinib compared with those exposed to acalabrutinib in the whole matched cohort
Time frame: from the introduction of the BTK inhibitor and up to 120 months
Risk of incident ventricular tachycardia/ventricular fibrillation/cardiac arrest (composite) in patients exposed to ibrutinib compared with those exposed to acalabrutinib in the whole matched cohort
Time frame: from the introduction of the BTK inhibitor and up to 120 months
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 21 Aug 2024.
- Derived from this study: PubMed 40038806Alexandre J, Font J, Lenormand T, Chantepie S, Bardet H, Damaj G, Dolladille C, Legallois D, Da-Silva A, Milliez P, Bisson A, Fauchier L. Ibrutinib and acalabrutinib use and risk of incident atrial fibrillation: a propensity-matched analysis. Exp Hematol Oncol. 2025 Mar 4;14(1):29. doi: 10.1186/s40164-025-00619-6.
- Individual participant dataSharing planned: No. Actually, data from TrinetX are only freely available for health care organizations participating to the health research network database.
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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.
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 Chronic B-cell Malignancies and BTK Inhibitors, run by University Hospital, Caen 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 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 21 Aug 2024. 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?
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?
Risk of incident atrial fibrillation in patients exposed to ibrutinib compared with those exposed to acalabrutinib in the whole matched cohort. (time frame: from the introduction of the BTK inhibitor and up to 120 months). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT06561243, which also lists 1 linked publication.
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 21 Aug 2024.