Clinical trial · Observational
Ibrutinib and Acalabrutinib Use and Risk of Atrial Fibrillation in Patients With Chronic B-cell Malignancies
- Source
- ClinicalTrials.gov
- Retrieved
- Sep 8, 2026
- Layer
- normalized (units and labels harmonized; values unchanged)
- Run
- ING-CLINICALTRIALS-20260908-000001
Summary
Brief summary (as posted)
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.
Conditions
Conditions (3)
Free-text conditions as registered, with the CancerIndex entity they were reconciled to and the match type.
| Condition (as posted) | Mapped entity | Match | Confidence |
|---|---|---|---|
| BTK Inhibitors | — | UNRESOLVED | — |
| Cardiovascular Diseases | — | UNRESOLVED | — |
| Chronic B-cell Malignancies | — | UNRESOLVED | — |
Interventions
Interventions (1)
| Intervention | Type | Mapped drug | Match |
|---|---|---|---|
| BTK inhibitor (Ibrutinib or Acalabrutinib) | Drug | — | UNRESOLVED |
Design
Arms and outcomes
Arms (2)
- label
- Ibrutinib
- description
- Adult patients with a chronic B-cell malignancy exposed to ibrutinib
- interventionNames
- Drug: BTK inhibitor (Ibrutinib or Acalabrutinib)
- label
- Acalabrutinib
- description
- Adult patients with a chronic B-cell malignancy exposed to acalabrutinib
- interventionNames
- Drug: BTK inhibitor (Ibrutinib or Acalabrutinib)
Primary outcomes (1)
- measure
- 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
- description
- ICD-10-CM code I48 will be used to identify AF during follow-up
Eligibility
Eligibility (as posted)
- Sex
- All
- Minimum age
- 18 Years
Show eligibility criteria text
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: \-
References
Publications (1)
- DERIVEDAlexandre 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. PMID 40038806