Clinical trial NCT05521178: Cardiotoxicities in Patients Receiving BTKi
Official title: A Multicenter, Prospective Cohort Study for Detection of Cardiotoxicities in Patients Receiving Ibrutinib or Acalabrutinib for CLL
Study type: OBSERVATIONAL
Overall status: WITHDRAWN
Conditions: Chronic Lymphocytic Leukemia
Small Lymphocytic Lymphoma
Keywords: Chronic Lymphocytic Leukemia
Small Lymphocytic Lymphoma
Lead sponsor: Dana-Farber Cancer Institute
Sponsor class: OTHER
Collaborators: name: AstraZeneca
First posted: 2022-08-30
Enrollment: 0
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: COHORT
Time perspective: PROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: 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.

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

Eligibility criteria: 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.

Primary outcomes:
measure: Incidence of atrial arrhythmias
timeFrame: During 6 months of BTK inhibitor therapy
Secondary outcomes:
measure: Incidence of ventricular arrhythmias
timeFrame: During 6 months of BTK inhibitor therapy
measure: Severity of ventricular arrythmia
timeFrame: During 6 months of BTK inhibitor therapy
Other outcomes:
Locations:
Study officials:
affiliation: Dana-Farber Cancer Institute
name: Inhye Ahn, MD
role: PRINCIPAL_INVESTIGATOR
References: