- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT04026737
Cardiovascular Effects of CART Cell Therapy (CVE-CART)
January 19, 2023 updated by: Abramson Cancer Center of the University of Pennsylvania
Cardiovascular Effects of Chimeric Antigen Receptor T-Cell (CART Cell) Therapy: An Observational Prospective Study
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.
Study Overview
Status
Completed
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 Type
Observational
Enrollment (Actual)
44
Contacts and Locations
This section provides the contact details for those conducting the study, and information on where this study is being conducted.
Study Locations
-
-
Pennsylvania
-
Philadelphia, Pennsylvania, United States, 19104
- Abramson Cancer Center of the University of Pennsylvania
-
-
Participation Criteria
Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.
Eligibility Criteria
Ages Eligible for Study
18 years and older (Adult, Older Adult)
Accepts Healthy Volunteers
N/A
Genders Eligible for Study
All
Sampling Method
Probability Sample
Study Population
Adult patients diagnosed with CD19+ malignancy (including but not limited to acute lymphoblastic leukemia, chronic lymphocytic leukemia, and difuse large B cell lymphoma) and scheduled for treatment with CART cells will be enrolled prior to infusion of CART cells.
Description
Inclusion Criteria:
- At least 18 years of age
- Diagnosed with CD19+ malignancy undergoing treatment with CART cells
Exclusion Criteria:
- Unable to provide informed consent
Study Plan
This section provides details of the study plan, including how the study is designed and what the study is measuring.
How is the study designed?
Design Details
- Observational Models: Cohort
- Time Perspectives: Prospective
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
Incidence of Left Ventricular (LV) Dysfunction
Time Frame: 6 months
|
LV dysfunction, defined as a decrease in LV ejection fraction of at least 10% to less than or equal to 53%
|
6 months
|
Secondary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
Incidence of Cardiovascular Events
Time Frame: 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
|
6 months
|
Collaborators and Investigators
This is where you will find people and organizations involved with this study.
Investigators
- Principal Investigator: Marielle Scherrer-Crosbie, MD, PhD, University of Pennsylvania
Study record dates
These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.
Study Major Dates
Study Start (Actual)
July 22, 2019
Primary Completion (Actual)
November 16, 2022
Study Completion (Actual)
November 16, 2022
Study Registration Dates
First Submitted
July 17, 2019
First Submitted That Met QC Criteria
July 17, 2019
First Posted (Actual)
July 19, 2019
Study Record Updates
Last Update Posted (Actual)
January 20, 2023
Last Update Submitted That Met QC Criteria
January 19, 2023
Last Verified
January 1, 2023
More Information
Terms related to this study
Additional Relevant MeSH Terms
Other Study ID Numbers
- UPCC01419
Plan for Individual participant data (IPD)
Plan to Share Individual Participant Data (IPD)?
Undecided
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
No
Studies a U.S. FDA-regulated device product
No
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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