Cardiovascular Events Among Adults Patients With Aggressive B-Cell Lymphoma Treated With Standard of Care Chimeric Antigen Receptor T Cell Therapy: A Single-Institution Experience
Trial Snapshot
- Phase
- Not Applicable
- Status
- Recruiting
- Sponsor
- M.D. Anderson Cancer Center
- Enrollment
- 150
- Locations
- 1
- Primary Endpoint
- To characterize cardiac events following standard of care (SOC)
Study Overview
Brief Summary
This study characterizes cardiac events following standard of care chimeric antigen receptor T cell therapy in patients with aggressive B-Cell Lymphoma that has come back (relapsed) or does not respond to treatment (refractory). The results from this study may allow a description of these events, their managements and outcome.
Detailed Description
PRIMARY OBJECTIVE:
I. To characterize cardiac events following standard of Care (SOC) chimeric antigen receptor T (CAR-T) cell therapy in adult patients with relapsed/refractory aggressive B-cell lymphoma.
OUTLINE:
Patients' medical records are reviewed retrospectively.
Study Design
- Study Type
- Observational
- Observational Model
- Cohort
- Time Perspective
- Retrospective
Eligibility Criteria
- Ages
- 18 Years to — (Adult, Older Adult)
- Sex
- All
- Accepts Healthy Volunteers
- No
Inclusion Criteria
- Adults (>= 18 years) with a diagnosis of aggressive B-cell lymphoma (such as transformed follicular lymphoma, diffuse large B-cell lymphoma, primary mediastinal B-cell lymphoma and high-grade B-cell lymphoma), who received standard of care (SOC) chimeric antigen receptor T (CAR-T) cell therapy at MD Anderson Cancer Center
Exclusion Criteria
- None
Outcomes
Primary Outcomes
To characterize cardiac events following standard of care (SOC)
Time Frame: through study completion, an average of 1 year
Summary statistics will be provided for patient demographic, and clinical and biological variables. Continuous variables will be presented as mean +/- standard deviation or median (interquartile range), as appropriate based on normality, and categorical variables will be presented as percentages. Continuous data will be compared with the use of unpaired Student's t-tests or Wilcoxon rank-sum tests, as appropriate. Categorical data will be compared using the chi-square or the Fisher exact test. Univariate analyses will be performed to determine the association between the time of cytokine release syndrome symptoms and tocilizumab administration with cardiovascular events. Statistical significance will be defined using a 2-tailed p value =\< 0.05.
To characterize cardiac events following chimeric antigen receptor T cell therapy (CAR-T)
Time Frame: through study completion, an average of 1 year
Summary statistics will be provided for patient demographic, and clinical and biological variables. Continuous variables will be presented as mean +/- standard deviation or median (interquartile range), as appropriate based on normality, and categorical variables will be presented as percentages. Continuous data will be compared with the use of unpaired Student's t-tests or Wilcoxon rank-sum tests, as appropriate. Categorical data will be compared using the chi-square or the Fisher exact test. Univariate analyses will be performed to determine the association between the time of cytokine release syndrome symptoms and tocilizumab administration with cardiovascular events. Statistical significance will be defined using a 2-tailed p value =\< 0.05.
Secondary Outcomes
No secondary outcomes reported
Investigators
Study Sites (1)
Identifiers
- NCT ID
- NCT04870853
- Other Study IDs
- 2020-0120, NCI-2021-02675
Dates
- First Submitted
- (5 years ago)
- First Posted
- (5 years ago)
- Primary Completion
- (last year)
- Study Completion
- (last year)
- Last Verified
- Last updated
- (2 years ago)
Regulatory & Sharing
- FDA Regulated Drug
- No
- Has Results
- No