Working...
ClinicalTrials.gov
ClinicalTrials.gov Menu

Cardiovascular Effects of CART Cell Therapy (CVE-CART)

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Know the risks and potential benefits of clinical studies and talk to your health care provider before participating. Read our disclaimer for details.
ClinicalTrials.gov Identifier: NCT04026737
Recruitment Status : Recruiting
First Posted : July 19, 2019
Last Update Posted : August 7, 2019
Sponsor:
Information provided by (Responsible Party):
Abramson Cancer Center of the University of Pennsylvania

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 disease
Leukemia Lymphoma Cardiotoxicity Risk Factor, Cardiovascular Immunotherapy

Layout table for study information
Study Type : Observational [Patient Registry]
Estimated Enrollment : 65 participants
Observational Model: Cohort
Time Perspective: Prospective
Target Follow-Up Duration: 6 Months
Official Title: Cardiovascular Effects of Chimeric Antigen Receptor T-Cell (CART Cell) Therapy: An Observational Prospective Study
Actual Study Start Date : July 22, 2019
Estimated Primary Completion Date : July 2021
Estimated Study Completion Date : July 2021

Resource links provided by the National Library of Medicine





Primary Outcome Measures :
  1. 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%


Secondary Outcome Measures :
  1. 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



Information from the National Library of Medicine

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.


Layout table for eligibility information
Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes 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.
Criteria

Inclusion Criteria:

  • At least 18 years of age
  • Diagnosed with CD19+ malignancy undergoing treatment with CART cells

Exclusion Criteria:

  • Unable to provide informed consent

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT04026737


Contacts
Layout table for location contacts
Contact: Marielle Scherrer-Crosbie, MD, PhD 215-662-4000 marielle.scherrer-crosbie@pennmedicine.upenn.edu

Locations
Layout table for location information
United States, Pennsylvania
Abramson Cancer Center of the University of Pennsylvania Recruiting
Philadelphia, Pennsylvania, United States, 19104
Contact: Marielle Scherrer-Crosbie, MD, PhD         
Sponsors and Collaborators
Abramson Cancer Center of the University of Pennsylvania
Investigators
Layout table for investigator information
Principal Investigator: Marielle Scherrer-Crosbie, MD, PhD University of Pennsylvania

Layout table for additonal information
Responsible Party: Abramson Cancer Center of the University of Pennsylvania
ClinicalTrials.gov Identifier: NCT04026737     History of Changes
Other Study ID Numbers: UPCC01419
First Posted: July 19, 2019    Key Record Dates
Last Update Posted: August 7, 2019
Last Verified: August 2019
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: Undecided

Layout table for additional information
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:
Cardiotoxicity of Cancer Therapy
Cardio-Oncology
CART Cell Therapy

Additional relevant MeSH terms:
Layout table for MeSH terms
Cardiotoxicity
Pathologic Processes
Drug-Related Side Effects and Adverse Reactions
Chemically-Induced Disorders
Radiation Injuries
Wounds and Injuries