NCT04870853

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.

Trial Health

43
At Risk

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Trial has exceeded expected completion date
Enrollment
150

participants targeted

Target at P50-P75 for all trials

Timeline
Completed

Started Apr 2020

Longer than P75 for all trials

Geographic Reach
1 country

1 active site

Status
unknown

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

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Study Timeline

Key milestones and dates

Study Start

First participant enrolled

April 2, 2020

Completed
1 year until next milestone

First Submitted

Initial submission to the registry

April 12, 2021

Completed
22 days until next milestone

First Posted

Study publicly available on registry

May 4, 2021

Completed
3.7 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

January 30, 2025

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

January 30, 2025

Completed
Last Updated

November 14, 2023

Status Verified

November 1, 2023

Enrollment Period

4.8 years

First QC Date

April 12, 2021

Last Update Submit

November 10, 2023

Conditions

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

Outcome Measures

Primary Outcomes (2)

  • 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

Study Arms (1)

Observational (medical record review)

Patients' medical records are reviewed retrospectively.

Other: Electronic Health Record Review

Interventions

Electronic Health Record ReviewOTHER

Medical records reviewed

Observational (medical record review)

Eligibility Criteria

Age18 Years+
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)
Sampling MethodNon-Probability Sample
Study Population

Adults (\>= 18 years) with a diagnosis of aggressive B-cell lymphoma, who received SOC CAR-T cell therapy at MD Anderson Cancer Center

You may qualify if:

  • 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

You may not qualify if:

  • None

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

M D Anderson Cancer Center

Houston, Texas, 77030, United States

RECRUITING

MeSH Terms

Conditions

Lymphoma, Large B-Cell, Diffuse

Condition Hierarchy (Ancestors)

Lymphoma, B-CellLymphoma, Non-HodgkinLymphomaNeoplasms by Histologic TypeNeoplasmsLymphoproliferative DisordersLymphatic DiseasesHemic and Lymphatic DiseasesImmunoproliferative DisordersImmune System Diseases

Study Officials

  • Raphael E Steiner

    M.D. Anderson Cancer Center

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
observational
Observational Model
COHORT
Time Perspective
RETROSPECTIVE
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

April 12, 2021

First Posted

May 4, 2021

Study Start

April 2, 2020

Primary Completion

January 30, 2025

Study Completion

January 30, 2025

Last Updated

November 14, 2023

Record last verified: 2023-11

Locations

US(1)