Ibrutinib and Acalabrutinib Use and Risk of Atrial Fibrillation in Patients With Chronic B-cell Malignancies

NCT06561243 | Active Not Recruiting FDA Drug

• 1 other identifier: Pharmaco072424
• Study Type: observational
• Target: 15,000
• Locations: 1 country
• Sites: 1

Brief 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.

Conditions

Chronic B-cell Malignancies; BTK Inhibitors; Cardiovascular Diseases

Outcome Measures

Primary Outcomes (1)

• 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

  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

  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

  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

  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

  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

  from the introduction of the BTK inhibitor and up to 120 months

Study Arms (2)

Ibrutinib

Adult patients with a chronic B-cell malignancy exposed to ibrutinib

Drug: BTK inhibitor (Ibrutinib or Acalabrutinib)

Acalabrutinib

Adult patients with a chronic B-cell malignancy exposed to acalabrutinib

Drug: BTK inhibitor (Ibrutinib or Acalabrutinib)

Interventions

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)

Acalabrutinib; Ibrutinib

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Age Groups: Adult (18-64), Older Adult (65+)
• Sampling Method: Non-Probability Sample

Study Population

adult patients - diagnose with chronic B-cell malignancies expose to ibrutinib or acalabrutinib in the TrinetX database

You may qualify if:

• 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

Sponsors & Collaborators

• University Hospital, Caen: lead

Study Sites (1)

Caen University Hospital, Department of Pharmacology

Caen, Normandy, France

Location

Related Publications (1)

• 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.

  PMID: 40038806 DERIVED

MeSH Terms

Conditions

Cardiovascular Diseases

Interventions

ibrutinib; acalabrutinib

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: RETROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Professor

Study Record Dates

• First Submitted: July 24, 2024
• First Posted: August 20, 2024
• Study Start: July 25, 2024
• Primary Completion: September 30, 2024
• Study Completion: October 30, 2024
• Last Updated: August 21, 2024

Record last verified: 2024-08

Data Sharing

• IPD Sharing: Will not share

Locations

FR (1)