Chronic B-cell MalignanciesNCT07283965
Zanubrutinib 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.
Trial summary
Background. Zanubrutinib 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?
- Zanubrutinib and Acalabrutinib
- How many people
- 15,000 participants
- Where
- No sites listed yet
- Study dates
- 22 Dec 2025to 31 Mar 2026
- Phase
- Observational
- Are there results?
- Not yet: the study is under way
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: adult patients - diagnose with chronic B-cell malignancies expose to zanubrutinib or acalabrutinib in the TrinetX database
Who may be able to join
- adult patients
- diagnose with chronic B-cell malignancies
- exposed to zanubrutinib or acalabrutinib
Who cannot join
- none
Trial locations and contacts
No sites are listed yet. Contact the study team or a site near you to ask about taking part.
About this study
Background. Zanubrutinib 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 zanubrutinib 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 zanubrutinib or acalabrutinib. Patients will be divided into 2 groups based on zanubrutinib or acalabrutinib exposure. After propensity score matching (PSM), Cox proportional hazard models will be used to calculate the hazard ratios (HRs) and 95% confidence intervals (CIs) to compare the 2 matched groups. The appropriateness of the proportional hazard assumption will be examined and risk differences (RDs) will be used if appropriate. Results will summarized with the use of Kaplan-Meier survival curves.
- Being tested
- Zanubrutinib, 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.
ZanubrutinibDrug
Adult patients with a chronic B-cell malignancy exposed to zanubrutinib
AcalabrutinibDrug
Adult patients with a chronic B-cell malignancy exposed to acalabrutinib
| Study group | Role | What they receive |
|---|---|---|
| Zanubrutinib | Adult patients with a chronic B-cell malignancy exposed to zanubrutinib Receives: Drug: Zanubrutinib | |
| Acalabrutinib | Adult patients with a chronic B-cell malignancy exposed to acalabrutinib Receives: Drug: 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 zanubrutinib compared with those exposed to acalabrutinib in the matched cohort.
Measured: from the introduction of the BTK inhibitor and up to 5 years
Secondary outcomes (6)
Risk of all-cause mortality in patients exposed to zanubrutinib compared with those exposed to acalabrutinib in thematched cohort
Measured: from the introduction of the BTK inhibitor and up to 5 years
Risk of incident intra-cerebral hemorrhage in patients exposed to zanubrutinib compared with those exposed to acalabrutinib in the matched cohort
Measured: from the introduction of the BTK inhibitor and up to 5 years
Risk of incident major bleeding in patients exposed to zanubrutinib compared with those exposed to acalabrutinib in the matched cohort
Measured: from the introduction of the BTK inhibitor and up to 5 years
Risk of incident hypertension in patients exposed to zanubrutinib compared with those exposed to acalabrutinib in the matched cohort
Measured: from the introduction of the BTK inhibitor and up to 5 years
Risk of incident MACE (composite) in patients exposed to zanubrutinib compared with those exposed to acalabrutinib in the matched cohort
Measured: from the introduction of the BTK inhibitor and up to 5 years
Risk of incident ventricular tachycardia/ventricular fibrillation/cardiac arrest (composite) in patients exposed to zanubrutinib compared with those exposed to acalabrutinib in the matched cohort
Measured: from the introduction of the BTK inhibitor and up to 5 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted16 Dec 2025
- Study start22 Dec 2025 (estimated)
- Primary completion15 Jan 2026 (estimated)
- Study completion31 Mar 2026 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- 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
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07283965
- Sponsor's protocol ID
- Pharmaco111525
- Status last verified
- Dec 2025
- First submitted
- 26 Nov 2025
- Last updated
- 16 Dec 2025
- 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.
Study at a glance
From the registry record, last updated by the sponsor on 16 Dec 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Zanubrutinib and Acalabrutinib Use and Risk of Atrial Fibrillation in Patients With Chronic B-cell Malignancies
- ClinicalTrials.gov ID
- NCT07283965
- Acronym / sponsor ID
- Pharmaco111525
- Study type
- Observational
- Recruitment status
- Not yet recruiting
- Enrolment
- 15,000 participants (estimated)
- Lead sponsor
- University Hospital, CaenUniversity, hospital or other
- Study start
- 22 Dec 2025 (estimated)
- Primary completion
- 15 Jan 2026 (estimated)
- Study completion
- 31 Mar 2026 (estimated)
- First posted
- 16 Dec 2025 (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. Zanubrutinib 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 zanubrutinib 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 zanubrutinib or acalabrutinib. Patients will be divided into 2 groups based on zanubrutinib or acalabrutinib exposure. After propensity score matching (PSM), Cox proportional hazard models will be used to calculate the hazard ratios (HRs) and 95% confidence intervals (CIs) to compare the 2 matched groups. The appropriateness of the proportional hazard assumption will be examined and risk differences (RDs) will be used if appropriate. Results will summarized with the use of Kaplan-Meier survival curves.
Study design
- Observational model
- Cohort
- Time perspective
- Retrospective
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Zanubrutinib | – | Drug: ZanubrutinibAdult patients with a chronic B-cell malignancy exposed to zanubrutinib |
| Acalabrutinib | – | Drug: AcalabrutinibAdult patients with a chronic B-cell malignancy exposed to acalabrutinib |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- adult patients - diagnose with chronic B-cell malignancies expose to zanubrutinib or acalabrutinib in the TrinetX database
Key inclusion criteria (3 listed)
- adult patients
- diagnose with chronic B-cell malignancies
- exposed to zanubrutinib or acalabrutinib
Key exclusion criteria (1 listed)
- none
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 |
|---|---|---|
| ZanubrutinibAdult patients with a chronic B-cell malignancy exposed to zanubrutinib | Drug | Zanubrutinib |
| AcalabrutinibAdult patients with a chronic B-cell malignancy exposed to acalabrutinib | Drug | Acalabrutinib |
Primary outcome
Risk of incident atrial fibrillation in patients exposed to zanubrutinib compared with those exposed to acalabrutinib in the matched cohort.
Time frame: from the introduction of the BTK inhibitor and up to 5 years
6 secondary outcomes
Risk of all-cause mortality in patients exposed to zanubrutinib compared with those exposed to acalabrutinib in thematched cohort
Time frame: from the introduction of the BTK inhibitor and up to 5 years
Risk of incident intra-cerebral hemorrhage in patients exposed to zanubrutinib compared with those exposed to acalabrutinib in the matched cohort
Time frame: from the introduction of the BTK inhibitor and up to 5 years
Risk of incident major bleeding in patients exposed to zanubrutinib compared with those exposed to acalabrutinib in the matched cohort
Time frame: from the introduction of the BTK inhibitor and up to 5 years
Risk of incident hypertension in patients exposed to zanubrutinib compared with those exposed to acalabrutinib in the matched cohort
Time frame: from the introduction of the BTK inhibitor and up to 5 years
Risk of incident MACE (composite) in patients exposed to zanubrutinib compared with those exposed to acalabrutinib in the matched cohort
Time frame: from the introduction of the BTK inhibitor and up to 5 years
Risk of incident ventricular tachycardia/ventricular fibrillation/cardiac arrest (composite) in patients exposed to zanubrutinib compared with those exposed to acalabrutinib in the matched cohort
Time frame: from the introduction of the BTK inhibitor and up to 5 months
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 16 Dec 2025.
- 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.
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.
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: opening soon, as of the sponsor's last update on 16 Dec 2025. Status can change between updates, so confirm with the study contact before making plans.
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?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Joachim Alexandre, MD, PhD (+33231064670, alexandre-j@chu-caen.fr), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Risk of incident atrial fibrillation in patients exposed to zanubrutinib compared with those exposed to acalabrutinib in the matched cohort. (time frame: from the introduction of the BTK inhibitor and up to 5 years). 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 16 Dec 2025.