4006-776-356 出国就医服务电话

免费获得国外相关药品，最快 1 个工作日回馈药物信息

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
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
Arms and Interventions
Outcome Measures
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


Biospecimen Retention:   Samples With DNA
plasma, serum, and buffy are banked

Eligibility Criteria
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
Contacts and Locations

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
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
 (submitted: July 17, 2019) 		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%
Original Primary Outcome Measures Same as current
Change History
Current Secondary Outcome Measures
 (submitted: July 17, 2019) 		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
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
  • Leukemia
  • Lymphoma
  • Cardiotoxicity
  • Risk Factor, Cardiovascular
  • Immunotherapy
Intervention Not Provided
Study Groups/Cohorts Not Provided
Publications * Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruitment Information
Recruitment Status Recruiting
Estimated Enrollment
 (submitted: July 17, 2019) 		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:

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

Exclusion Criteria:

  • Unable to provide informed consent
Sex/Gender
Sexes Eligible for Study: All
Ages 18 Years and older   (Adult, Older Adult)
Accepts Healthy Volunteers Not Provided
Contacts
Contact: Marielle Scherrer-Crosbie, MD, PhD 215-662-4000 marielle.scherrer-crosbie@pennmedicine.upenn.edu
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
Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
IPD Sharing Statement
Plan to Share IPD: Undecided
Responsible Party Abramson Cancer Center of the University of Pennsylvania
Study Sponsor Abramson Cancer Center of the University of Pennsylvania
Collaborators Not Provided
Investigators
Principal Investigator: Marielle Scherrer-Crosbie, MD, PhD University of Pennsylvania
PRS Account Abramson Cancer Center of the University of Pennsylvania
Verification Date August 2020

治疗医院

新药特效药

治疗案例

前沿医讯