CVE-CART: Cardiovascular Effects of CART Cell Therapy

Sponsor
Abramson Cancer Center of the University of Pennsylvania (Other)
Overall Status
Recruiting
CT.gov ID
NCT04026737
Collaborator
(none)
65
Enrollment
1
Location
35.3
Anticipated Duration (Months)
1.8
Patients Per Site Per Month

Study Details

Study Description

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.

Condition or DiseaseIntervention/TreatmentPhase

    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.

    Study Design

    Study Type:
    Observational [Patient Registry]
    Anticipated Enrollment :
    65 participants
    Observational Model:
    Cohort
    Time Perspective:
    Prospective
    Official Title:
    Cardiovascular Effects of Chimeric Antigen Receptor T-Cell (CART Cell) Therapy: An Observational Prospective Study
    Actual Study Start Date :
    Jul 22, 2019
    Anticipated Primary Completion Date :
    Jul 1, 2022
    Anticipated Study Completion Date :
    Jul 1, 2022

    Outcome Measures

    Primary Outcome Measures

    1. 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

    1. 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

    Eligibility Criteria

    Criteria

    Ages Eligible for Study:
    18 Years and Older
    Sexes Eligible for Study:
    All
    Inclusion Criteria:
    • At least 18 years of age

    • Diagnosed with CD19+ malignancy undergoing treatment with CART cells

    Exclusion Criteria:
    • Unable to provide informed consent

    Contacts and Locations

    Locations

    SiteCityStateCountryPostal Code
    1Abramson Cancer Center of the University of PennsylvaniaPhiladelphiaPennsylvaniaUnited States19104

    Sponsors and Collaborators

    • Abramson Cancer Center of the University of Pennsylvania

    Investigators

    • Principal Investigator: Marielle Scherrer-Crosbie, MD, PhD, University of Pennsylvania

    Study Documents (Full-Text)

    None provided.

    More Information

    Publications

    None provided.
    Responsible Party:
    Abramson Cancer Center of the University of Pennsylvania
    ClinicalTrials.gov Identifier:
    NCT04026737
    Other Study ID Numbers:
    • UPCC01419
    First Posted:
    Jul 19, 2019
    Last Update Posted:
    Oct 1, 2021
    Last Verified:
    Sep 1, 2021
    Individual Participant Data (IPD) Sharing Statement:
    Undecided
    Plan to Share IPD:
    Undecided
    Studies a U.S. FDA-regulated Drug Product:
    No
    Studies a U.S. FDA-regulated Device Product:
    No
    Keywords provided by Abramson Cancer Center of the University of Pennsylvania
    Additional relevant MeSH terms:

    Study Results

    No Results Posted as of Oct 1, 2021