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Cardiovascular Effects of CART Cell Therapy (CVE-CART)

Abramson Cancer Center at Penn Medicine logo

Abramson Cancer Center at Penn Medicine

Status

Completed

Conditions

Cardiotoxicity
Immunotherapy
Lymphoma
Leukemia
Risk Factor, Cardiovascular

Study type

Observational

Funder types

Other

Identifiers

NCT04026737
UPCC01419

Details and patient eligibility

About

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.

Full 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.

Enrollment

44 patients

Sex

All

Ages

18+ years old

Volunteers

No 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

Trial contacts and locations

1

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Data sourced from clinicaltrials.gov

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