Cardiovascular Effects of CART Cell Therapy

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

Status

Completed

Phases

Unknown

Study type

Observational

Source

ClinicalTrials.gov

Registry ID

NCT04026737

Acronym

CVE-CART

Enrollment

Registered

2019-07-19

Start date

2019-07-22

Completion date

2022-11-16

Last updated

2026-02-09

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

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

Keywords

Cardiotoxicity of Cancer Therapy, Cardio-Oncology, CART Cell Therapy

Brief 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.

Detailed 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.

Interventions

None listed

Study design

Observational model

COHORT

Time perspective

PROSPECTIVE

Eligibility

Sex/Gender

ALL

Age

18 Years to No maximum

Healthy volunteers

Inclusion criteria

* At least 18 years of age * Diagnosed with CD19+ malignancy undergoing treatment with CART cells

Exclusion criteria

* Unable to provide informed consent

Design outcomes

Primary

Measure	Time frame	Description
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

Measure	Time frame	Description
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

Countries

United States

Contacts

PRINCIPAL_INVESTIGATORMarielle Scherrer-Crosbie, MD, PhD

University of Pennsylvania

Outcome results