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| ID | Type | Description | Link |
|---|---|---|---|
| NCI-2021-02675 | Registry Identifier | CTRP (Clinical Trial Reporting Program) | |
| 2020-0120 | Other Identifier | M D Anderson Cancer Center |
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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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Observational (medical record review) | Patients' medical records are reviewed retrospectively. |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Electronic Health Record Review | Other | Medical records reviewed |
|
| Measure | Description | Time Frame |
|---|---|---|
| To 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. | 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. | through study completion, an average of 1 year |
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Inclusion Criteria:
Exclusion Criteria:
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Adults (>= 18 years) with a diagnosis of aggressive B-cell lymphoma, who received SOC CAR-T cell therapy at MD Anderson Cancer Center
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| Name | Affiliation | Role |
|---|---|---|
| Raphael E Steiner | M.D. Anderson Cancer Center | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| M D Anderson Cancer Center | Recruiting | Houston | Texas | 77030 | United States |
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| ID | Term |
|---|---|
| D016403 | Lymphoma, Large B-Cell, Diffuse |
| ID | Term |
|---|---|
| D016393 | Lymphoma, B-Cell |
| D008228 | Lymphoma, Non-Hodgkin |
| D008223 | Lymphoma |
| D009370 | Neoplasms by Histologic Type |
| D009369 | Neoplasms |
| D008232 | Lymphoproliferative Disorders |
| D008206 | Lymphatic Diseases |
| D006425 | Hemic and Lymphatic Diseases |
| D007160 | Immunoproliferative Disorders |
| D007154 | Immune System Diseases |
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