Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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WITHDRAWN
OBSERVATIONAL
2024-05-31
2028-01-01
Brief Summary
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Detailed Description
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* Blood sample collection
* Electrocardiogram (ECG)
* Echocardiogram
* Cardiac magnetic resonance imaging (MRI)
* Mobile cardiac telemetry
* Blood pressure measurement
Conditions
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Study Design
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COHORT
PROSPECTIVE
Study Groups
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Ibrutinib
Patients receiving ibrutinib for the treatment of CLL.
Electrocardiogram
ECG to monitor electrical activities of the heart on each visit
Echocardiogram
Echocardiogram at baseline and 6 months
Cardiac magnetic resonance imaging
Cardiac MRI at baseline and 6 months
Mobile cardiac telemetry
Mobile cardiac telemetry at baseline and 6 months
Blood pressure monitoring
Home blood pressure monitoring three times per week
Blood draw
Blood draw at baseline, 3 and 6 months
Acalabrutinib
Patients receiving acalabrutinib for the treatment of CLL.
Electrocardiogram
ECG to monitor electrical activities of the heart on each visit
Echocardiogram
Echocardiogram at baseline and 6 months
Cardiac magnetic resonance imaging
Cardiac MRI at baseline and 6 months
Mobile cardiac telemetry
Mobile cardiac telemetry at baseline and 6 months
Blood pressure monitoring
Home blood pressure monitoring three times per week
Blood draw
Blood draw at baseline, 3 and 6 months
Interventions
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Electrocardiogram
ECG to monitor electrical activities of the heart on each visit
Echocardiogram
Echocardiogram at baseline and 6 months
Cardiac magnetic resonance imaging
Cardiac MRI at baseline and 6 months
Mobile cardiac telemetry
Mobile cardiac telemetry at baseline and 6 months
Blood pressure monitoring
Home blood pressure monitoring three times per week
Blood draw
Blood draw at baseline, 3 and 6 months
Other Intervention Names
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Eligibility Criteria
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Inclusion Criteria
* 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
* 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.
18 Years
ALL
No
Sponsors
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AstraZeneca
INDUSTRY
Dana-Farber Cancer Institute
OTHER
Responsible Party
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Inhye Ahn
Principal Investigator
Principal Investigators
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Inhye Ahn, MD
Role: PRINCIPAL_INVESTIGATOR
Dana-Farber Cancer Institute
Other Identifiers
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22-301
Identifier Type: -
Identifier Source: org_study_id
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