LeukemiaCVE-CARTNCT04026737
Cardiovascular Effects of CART Cell Therapy
An observational study of Leukemia and Lymphoma, run by Abramson Cancer Center at Penn Medicine at 1 site in United States.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Leukemia, Lymphoma, Cardiotoxicity
- How many people
- 44 participants
- Where
- 1 siteUnited States
- Study dates
- 22 Jul 2019to 16 Nov 2022
- How long will I take part?
- 6 Months
- Phase
- Observational
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
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.
Who may be able to join
- At least 18 years of age
- Diagnosed with CD19+ malignancy undergoing treatment with CART cells
Who cannot join
- Unable to provide informed consent
Trial locations and contacts
1 site in 1 country.
United States1 site
Abramson Cancer Center of the University of Pennsylvania
Philadelphia, Pennsylvania, 19104
About this study
Official title: 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.
Read the 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
- Keywords
- Cardiotoxicity of Cancer Therapy, Cardio-Oncology, CART Cell Therapy
- Medical subject headings
- Leukemia, Lymphoma, Cardiotoxicity
What is being measured
The primary outcome is the main question the study is designed to answer.
Incidence of Left Ventricular (LV) Dysfunction
LV dysfunction, defined as a decrease in LV ejection fraction of at least 10% to less than or equal to 53%
Measured: 6 months
Secondary outcomes (1)
Incidence of Cardiovascular Events
Cardiovascular events are defined as hospitalization for symptomatic congestive heart disease, nonfatal acute coronary syndrome, cardiovascular death, nonfatal stroke, and all-cause mortality
Measured: 6 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted19 Jul 2019
- Study start22 Jul 2019
- Primary completion16 Nov 2022
- Study completion16 Nov 2022
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for LeukemiaStudies of the same condition, open and under way.
- More trials run by Abramson Cancer Center at Penn MedicineThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Cohort
- Time perspective
- Prospective
- Enrolment
- 44 participants (actual)
- Target duration
- 6 Months
Sponsor and investigators
- Lead sponsor
- Abramson Cancer Center at Penn Medicine
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Marielle Scherrer-Crosbie, MD, PhD, Principal investigator, University of Pennsylvania
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04026737
- Sponsor's protocol ID
- UPCC01419
- Acronym
- CVE-CART
- Status last verified
- Feb 2026
- First submitted
- 17 Jul 2019
- Last updated
- 9 Feb 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Undecided
Study at a glance
From the registry record, last updated by the sponsor on 9 Feb 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Cardiovascular Effects of Chimeric Antigen Receptor T-Cell (CART Cell) Therapy: An Observational Prospective Study
- ClinicalTrials.gov ID
- NCT04026737
- Acronym / sponsor ID
- CVE-CART / UPCC01419
- Conditions
- Leukemia, Lymphoma, Cardiotoxicity, Risk Factor, Cardiovascular, Immunotherapy
- Keywords
- Cardiotoxicity of Cancer Therapy, Cardio-Oncology, CART Cell Therapy
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 44 participants (actual)
- Lead sponsor
- Abramson Cancer Center at Penn MedicineUniversity, hospital or other
- Study start
- 22 Jul 2019 (actual)
- Primary completion
- 16 Nov 2022 (actual)
- Study completion
- 16 Nov 2022 (actual)
- First posted
- 19 Jul 2019 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
- Target follow-up
- 6 Months
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- 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.
Key inclusion criteria (2 listed)
- At least 18 years of age
- Diagnosed with CD19+ malignancy undergoing treatment with CART cells
Key exclusion criteria (1 listed)
- Unable to provide informed consent
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Primary outcome
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%
1 secondary outcome
Incidence of Cardiovascular Events
Time frame: 6 months
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 9 Feb 2026.
- Individual participant dataSharing planned: Undecided
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Marielle Scherrer-Crosbie, MD, PhD principal investigator
University of Pennsylvania
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Leukemia and Lymphoma, run by Abramson Cancer Center at Penn Medicine at 1 site in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 2 inclusion and 1 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 9 Feb 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Incidence of Left Ventricular (LV) Dysfunction (time frame: 6 months). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 9 Feb 2026.