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.
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 Type
OBSERVATIONAL
Enrollment
150
Medical records reviewed
M D Anderson Cancer Center
Houston, Texas, United States
RECRUITINGTo characterize cardiac events following standard of care (SOC)
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.
Time frame: through study completion, an average of 1 year
To characterize cardiac events following chimeric antigen receptor T cell therapy (CAR-T)
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.
Time frame: through study completion, an average of 1 year
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