Chronic Lymphocytic Leukemia, Small Lymphocytic Lymphoma
Conditions
Keywords
Chronic Lymphocytic Leukemia, Small Lymphocytic Lymphoma
Brief summary
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.
Detailed description
This research study includes three visits for research blood, physical exam, and cardiac testing at baseline, 3 months, and 6 months. The study will collect the following data during the 6-month study period: * Blood sample collection * Electrocardiogram (ECG) * Echocardiogram * Cardiac magnetic resonance imaging (MRI) * Mobile cardiac telemetry * Blood pressure measurement
Interventions
DIAGNOSTIC_TESTElectrocardiogram
ECG to monitor electrical activities of the heart on each visit
DIAGNOSTIC_TESTEchocardiogram
Echocardiogram at baseline and 6 months
DIAGNOSTIC_TESTCardiac magnetic resonance imaging
Cardiac MRI at baseline and 6 months
DEVICEMobile cardiac telemetry
Mobile cardiac telemetry at baseline and 6 months
DIAGNOSTIC_TESTBlood pressure monitoring
Home blood pressure monitoring three times per week
DIAGNOSTIC_TESTBlood draw
Blood draw at baseline, 3 and 6 months
Sponsors
AstraZeneca
Dana-Farber Cancer Institute
Study design
Observational model
COHORT
Time perspective
PROSPECTIVE
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No
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.
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Incidence of atrial arrhythmias | During 6 months of BTK inhibitor therapy | Any documented evidence of atrial arrhythmia including symptomatic and asymptomatic events captured by EKG, 28-day mini cardiac telemetry, or monitoring of cardiac rhythm during echocardiogram or cardiac MRI. |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Incidence of ventricular arrhythmias | During 6 months of BTK inhibitor therapy | Assessed by 28-day mobile telemetry |
| Severity of ventricular arrythmia | During 6 months of BTK inhibitor therapy | NCI Common Terminology Criteria for Adverse Events (CTCAE) version 5.0 |
Outcome results
None listed