Cardiovascular Events Among Adults Patients With Relapsed or Refractory Aggressive B-Cell Lymphoma Treated With Standard of Care Chimeric Antigen Receptor T Cell Therapy

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.

Official Title
-----------------
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

Conditions
-----------------
Recurrent Transformed Follicular Lymphoma to Diffuse Large B-Cell Lymphoma, Refractory Aggressive B-Cell Non-Hodgkin Lymphoma, Refractory Diffuse Large B-Cell Lymphoma, Refractory High Grade B-Cell Lymphoma, Refractory Primary Mediastinal (Thymic) Large B-Cell Lymphoma, Recurrent Aggressive B-Cell Non-Hodgkin Lymphoma, Recurrent Diffuse Large B-Cell Lymphoma, Recurrent High Grade B-Cell Lymphoma, Recurrent Primary Mediastinal (Thymic) Large B-Cell Lymphoma, Refractory Transformed Follicular Lymphoma to Diffuse Large B-Cell Lymphoma

Intervention / Treatment
-----------------
* Other: Electronic Health Record Review


Participation Criteria
=================
Eligibility Criteria
-----------------
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

Ages Eligible for Study
-----------------
Minimum Age: 18 Years

Sexes Eligible for Study
-----------------
All

Accepts Healthy Volunteers
-----------------
No

Study Plan
=================
How is the study designed?
-----------------

Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Observational (medical record review)<br>Patients' medical records are reviewed retrospectively. | Other: Electronic Health Record Review<br>* Medical records reviewed<br>|

What is the study measuring?
-----------------
Primary Outcome Measures

| Outcome Measure | 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 |