Clinical trial · Observational
Cardiotoxicities in Patients Receiving BTKi
A Multicenter, Prospective Cohort Study for Detection of Cardiotoxicities in Patients Receiving Ibrutinib or Acalabrutinib for CLL
NCT05521178CI-TRIAL-00081535withdrawnClinicalTrials.gov clinicaltrialsProvenance
- Source
- ClinicalTrials.gov
- Retrieved
- Sep 8, 2026
- Layer
- normalized (units and labels harmonized; values unchanged)
- Run
- ING-CLINICALTRIALS-20260908-000001
Why stopped (as posted): Funding for study was withdrawn
Summary
Brief summary (as posted)
This is a multicenter, prospective, observational cohort study to comprehensively and longitudinally evaluate and characterizes the cardiovascular events with CLL patients who are initiating treatment with a Bruton's tyrosine kinase (BTK) inhibitor ibrutinib or acalabrutinib.
Conditions
Conditions (2)
Free-text conditions as registered, with the CancerIndex entity they were reconciled to and the match type.
| Condition (as posted) | Mapped entity | Match | Confidence |
|---|---|---|---|
| Chronic Lymphocytic Leukemia | Chronic Lymphocytic Leukemia | ONTOLOGY_EXACT | 0.98 |
| Small Lymphocytic Lymphoma | Small Lymphocytic Lymphoma | ONTOLOGY_EXACT | 0.98 |
Interventions
Interventions (6)
| Intervention | Type | Mapped drug | Match |
|---|---|---|---|
| Blood draw | Diagnostic Test | — | UNRESOLVED |
| Blood pressure monitoring | Diagnostic Test | — | UNRESOLVED |
| Cardiac magnetic resonance imaging | Diagnostic Test | — | UNRESOLVED |
| Echocardiogram | Diagnostic Test | — | UNRESOLVED |
| Electrocardiogram | Diagnostic Test | — | UNRESOLVED |
| Mobile cardiac telemetry | Device | — | UNRESOLVED |
Design
Arms and outcomes
Arms (2)
- label
- Ibrutinib
- description
- Patients receiving ibrutinib for the treatment of CLL.
- interventionNames
- Diagnostic Test: Electrocardiogram
- Diagnostic Test: Echocardiogram
- Diagnostic Test: Cardiac magnetic resonance imaging
- Device: Mobile cardiac telemetry
- Diagnostic Test: Blood pressure monitoring
- Diagnostic Test: Blood draw
- label
- Acalabrutinib
- description
- Patients receiving acalabrutinib for the treatment of CLL.
- interventionNames
- Diagnostic Test: Electrocardiogram
- Diagnostic Test: Echocardiogram
- Diagnostic Test: Cardiac magnetic resonance imaging
- Device: Mobile cardiac telemetry
- Diagnostic Test: Blood pressure monitoring
- Diagnostic Test: Blood draw
Primary outcomes (1)
Eligibility
Eligibility (as posted)
- Sex
- All
- Minimum age
- 18 Years
Show eligibility criteria text
Inclusion criteria * Patients with confirmed diagnosis of CLL who are planned to start either ibrutinib or acalabrutinib per standard of care, in monotherapy or in combination with an anti-CD20 antibody, venetoclax, and/or a PI3K inhibitor. Both treatment-naïve and relapsed or refractory CLL are allowed. * No known history of paroxysmal, persistent, or permanent atrial fibrillation. Exception: The study allows enrollment of up to 10 patients with a known history of paroxysmal atrial fibrillation (exploratory cohort). * No known history chronic symptomatic congestive heart failure or documented ejection fraction \< 50%. * Creatinine ≤ 1.5x institutional upper limit of normal (ULN). An adequate kidney function is necessary to ensure safety of IV contrast given before cardiac MRI. * Age ≥18 years. * ECOG performance status ≤2 (Karnofsky ≥60%). Exclusion criteria * Prior exposure to ibrutinib or acalabrutinib. * Patients with a clinical contraindication to MRI. * Patients with childbearing potential who cannot or do not wish to use an effective method of contraception, during the study period and for 12 months after the final treatment used for the purposes of the study. * Patients with any medical condition, psychiatric condition, or social situation that in the opinion of the investigator would compromise compliance with study requirements.
References
Publications (0)
Data not yet available
No reference posted for this study.