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出境医 / 临床实验 / Cardiovascular Effects of CART Cell Therapy (CVE-CART)
Cardiovascular Effects of CART Cell Therapy (CVE-CART)
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 disease |
|---|
| Leukemia Lymphoma Cardiotoxicity Risk Factor, Cardiovascular Immunotherapy |
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] |
| 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 |
Arms and Interventions
Outcome Measures
Primary Outcome Measures :
- 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 :
- 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
Biospecimen Retention: Samples With DNA
plasma, serum, and buffy are banked
Eligibility Criteria
| 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
Contacts and Locations
Contacts
| Contact: Marielle Scherrer-Crosbie, MD, PhD | 215-662-4000 | marielle.scherrer-crosbie@pennmedicine.upenn.edu |
Locations
| 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
| Principal Investigator: | Marielle Scherrer-Crosbie, MD, PhD | University of Pennsylvania |
| Tracking Information | |||||
|---|---|---|---|---|---|
| First Submitted Date | July 17, 2019 | ||||
| First Posted Date | July 19, 2019 | ||||
| Last Update Posted Date | August 26, 2020 | ||||
| Actual Study Start Date | July 22, 2019 | ||||
| Estimated Primary Completion Date | July 2021 (Final data collection date for primary outcome measure) | ||||
| Current Primary Outcome Measures |
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%
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| Original Primary Outcome Measures | Same as current | ||||
| Change History | |||||
| Current Secondary Outcome Measures |
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
|
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| Original Secondary Outcome Measures | Same as current | ||||
| Current Other Pre-specified Outcome Measures | Not Provided | ||||
| Original Other Pre-specified Outcome Measures | Not Provided | ||||
| Descriptive Information | |||||
| Brief Title | Cardiovascular Effects of CART Cell Therapy | ||||
| Official Title | Cardiovascular Effects of Chimeric Antigen Receptor T-Cell (CART Cell) Therapy: An Observational Prospective Study | ||||
| 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. | ||||
| 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 [Patient Registry] | ||||
| Study Design | Observational Model: Cohort Time Perspective: Prospective |
||||
| Target Follow-Up Duration | 6 Months | ||||
| Biospecimen | Retention: Samples With DNA Description:
plasma, serum, and buffy are banked
|
||||
| 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. | ||||
| Condition |
|
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| Intervention | Not Provided | ||||
| Study Groups/Cohorts | Not Provided | ||||
| Publications * | Not Provided | ||||
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* Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline. |
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| Recruitment Information | |||||
| Recruitment Status | Recruiting | ||||
| Estimated Enrollment |
65 | ||||
| Original Estimated Enrollment | Same as current | ||||
| Estimated Study Completion Date | July 2021 | ||||
| Estimated Primary Completion Date | July 2021 (Final data collection date for primary outcome measure) | ||||
| Eligibility Criteria |
Inclusion Criteria:
Exclusion Criteria:
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| Sex/Gender |
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| Ages | 18 Years and older (Adult, Older Adult) | ||||
| Accepts Healthy Volunteers | Not Provided | ||||
| Contacts |
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| Listed Location Countries | United States | ||||
| Removed Location Countries | |||||
| Administrative Information | |||||
| NCT Number | NCT04026737 | ||||
| Other Study ID Numbers | UPCC01419 | ||||
| Has Data Monitoring Committee | No | ||||
| U.S. FDA-regulated Product |
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| IPD Sharing Statement |
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| Responsible Party | Abramson Cancer Center of the University of Pennsylvania | ||||
| Study Sponsor | Abramson Cancer Center of the University of Pennsylvania | ||||
| Collaborators | Not Provided | ||||
| Investigators |
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| PRS Account | Abramson Cancer Center of the University of Pennsylvania | ||||
| Verification Date | August 2020 | ||||
