Ibrutinib and Acalabrutinib Use and Risk of Atrial Fibrillation in Patients With Chronic B-cell M… (NCT06561243) | Clinical Trial Compass
Active — Not RecruitingNot Applicable
Ibrutinib and Acalabrutinib Use and Risk of Atrial Fibrillation in Patients With Chronic B-cell Malignancies
France15,000 participantsStarted 2024-07-25
Plain-language 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. 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.
Who can participate
Age range
18 Years
Sex
ALL
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Inclusion Criteria:
* 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
Exclusion Criteria:
\-
Questions worth asking your doctor
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1Based on my diagnosis and history, is this trial worth exploring for me — or is there a standard treatment we should try first?
2What does this trial's phase tell us about how much is already known about its safety and benefit?
3What would taking part actually involve for me — visits, tests, time, and travel?
4What are the known and possible risks or side effects I should weigh, and how would they be monitored?
5If this trial isn't the right fit, what other options or trials would you suggest I look into?
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Questions for the trial coordinator
The trial coordinator is the person who runs the study day to day. These cover the practical side — logistics, costs, and what taking part would actually mean for your life. The study team confirms whether you meet the criteria; these are questions to ask, not a sign you qualify.
1What does taking part actually involve week to week — how many visits, where, and how long does each one take?
2What costs are covered by the study, and what might I have to pay for myself, including travel, parking, or time off work?
3What happens during screening, and what happens if the study team confirms I don't meet the criteria after those tests?
4Who pays for the scans, blood work, and other tests the trial requires — the study, my insurance, or me?
5How will being in the trial affect my regular care, and will my own doctor stay informed and involved?
6Can I leave the trial at any point if I change my mind, and what would happen to my care if I do?
A starting point for the conversation — always confirm anything about your own eligibility, costs, and care with the study team and your doctor.
What they're measuring
1
Risk of incident atrial fibrillation in patients exposed to ibrutinib compared with those exposed to acalabrutinib in the whole matched cohort.
Timeframe: from the introduction of the BTK inhibitor and up to 120 months