CVE-CART: Cardiovascular Effects of CART Cell Therapy
This is an observational study aiming to prospectively define the rate of occurrence, natural history and progression of cardiac dysfunction in adults, and to identify the patients at high risk of developing cardiovascular events. The study enrolls patients prior to infusion with CART cell therapy and follows them with serial echocardiography, cardiac biomarkers, clinical data, and quality of life questionnaire.
|Condition or Disease||Intervention/Treatment||Phase|
Patients have echo, blood draw, and QoL survey prior to CART infusion, then 2 days, 1 week, 1 month and 6 months following CART infusion. If patients experiences CRS, study team acquires echo within 72 hours of onset. As part of an optional substudy, patients wear an event monitor for 10 days, starting day of CART infusion.
Primary Outcome Measures
- Incidence of Left Ventricular (LV) Dysfunction [6 months]
LV dysfunction, defined as a decrease in LV ejection fraction of at least 10% to less than or equal to 53%
Secondary Outcome Measures
- Incidence of Cardiovascular Events [6 months]
Cardiovascular events are defined as hospitalization for symptomatic congestive heart disease, nonfatal acute coronary syndrome, cardiovascular death, nonfatal stroke, and all-cause mortality
At least 18 years of age
Diagnosed with CD19+ malignancy undergoing treatment with CART cells
- Unable to provide informed consent
Contacts and Locations
|1||Abramson Cancer Center of the University of Pennsylvania||Philadelphia||Pennsylvania||United States||19104|
Sponsors and Collaborators
- Abramson Cancer Center of the University of Pennsylvania
- Principal Investigator: Marielle Scherrer-Crosbie, MD, PhD, University of Pennsylvania
Study Documents (Full-Text)None provided.