NCT04026737

Cardiovascular Effects of CART Cell Therapy

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

• Status: Completed
• Phase: —
• Study type: Observational
• Enrollment: 44 (actual)
• Sponsor: Abramson Cancer Center at Penn Medicine · Academic / Other
• Sex: All
• Age: 18 Years
• Healthy volunteers: Not accepted

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.

Conditions

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

Timeline

• Start date: 2019-07-22
• Primary completion: 2022-11-16
• Completion: 2022-11-16
• First posted: 2019-07-19
• Last updated: 2026-02-09

Locations

1 site across 1 country: United States