Cardiovascular Effects of CART Cell Therapy

Lymphoma Clinical Trial

— CVE-CART  

Official title:

Cardiovascular Effects of Chimeric Antigen Receptor T-Cell (CART Cell) Therapy: An Observational Prospective Study

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT04026737
• Other study ID #: UPCC01419
• Status: Completed
• Start date: July 22, 2019
• Est. completion date: November 16, 2022

Study information

• Verified date: January 2023
• Source: Abramson Cancer Center of the University of Pennsylvania
• Contact: n/a
• Is FDA regulated: No
• Study type: Observational [Patient Registry]

Clinical Trial Summary

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.

Description:

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 44
• Est. completion date: November 16, 2022
• Est. primary completion date: November 16, 2022
• Gender: All
• Age group: 18 Years and older

Eligibility

Inclusion Criteria:

• At least 18 years of age

• Diagnosed with CD19+ malignancy undergoing treatment with CART cells

Exclusion Criteria:

• Unable to provide informed consent

Related Conditions & MeSH terms

• Cardiotoxicity
• Immunotherapy
• Leukemia
• Lymphoma
• Risk Factor, Cardiovascular

Locations

Country	Name	City	State
United States	Abramson Cancer Center of the University of Pennsylvania	Philadelphia	Pennsylvania

Sponsors (1)

Lead Sponsor	Collaborator
Abramson Cancer Center of the University of Pennsylvania

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Incidence of Left Ventricular (LV) Dysfunction	LV dysfunction, defined as a decrease in LV ejection fraction of at least 10% to less than or equal to 53%	6 months
Secondary	Incidence of Cardiovascular Events	Cardiovascular events are defined as hospitalization for symptomatic congestive heart disease, nonfatal acute coronary syndrome, cardiovascular death, nonfatal stroke, and all-cause mortality	6 months