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

Refractory Diffuse Large B-Cell Lymphoma Clinical Trial

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

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT04870853
• Other study ID #: 2020-0120
• Secondary ID: NCI-2021-0267520
• Status: Recruiting
• Start date: April 2, 2020
• Est. completion date: January 30, 2025

Study information

• Verified date: November 2023
• Source: M.D. Anderson Cancer Center
• Contact: n/a
• Is FDA regulated: No
• Study type: Observational

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 150
• Est. completion date: January 30, 2025
• Est. primary completion date: January 30, 2025
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

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

Related Conditions & MeSH terms

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

Intervention

Other:
• Electronic Health Record Review
Medical records reviewed

Locations

Country	Name	City	State
United States	M D Anderson Cancer Center	Houston	Texas

Sponsors (1)

Lead Sponsor	Collaborator
M.D. Anderson Cancer Center

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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
Primary	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