Recruiting

CAR T Cell Therapy

Sponsor:

M.D. Anderson Cancer Center

Code:

NCT04870853

Conditions

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

Recurrent Transformed Follicular Lymphoma to Diffuse Large B-Cell Lymphoma

Eligibility Criteria

Sex: All

Age: 18+

Healthy Volunteers: Not accepted

Interventions

Electronic Health Record Review

Study Details

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.

Conditions

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

Recurrent Transformed Follicular Lymphoma to Diffuse Large B-Cell Lymphoma

Study ID

NCT04870853

Start date

Apr 2, 2020

Status verified date

Nov, 2023

Completion date

Jan 30, 2025

Anticipated

Primary completion date

Jan 30, 2025

Anticipated

Eligibility Criteria

Eligibility Criteria

Sex: All

Age: 18+

Healthy Volunteers: Not accepted

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

Study Design

Enrollment

150 participants

Anticipated

Interventions and Outcome Measures

Arms

Observational (medical record review)

Patients' medical records are reviewed retrospectively.

Interventions

Electronic Health Record Review

Medical records reviewed

Primary outcome measure

  • To characterize cardiac events following standard of care (SOC) [ Time Frame: through study completion, an average of 1 year ]
  • To characterize cardiac events following chimeric antigen receptor T cell therapy (CAR-T) [ Time Frame: through study completion, an average of 1 year ]

Central Contacts and Locations

Locations

M D Anderson Cancer Center

Recruiting

Houston, Texas, United States, 77030

Contacts

Raphael E. Steiner

713-792-2860RESteiner1@mdanderson.org

Principal Investigator:

Raphael E. Steiner

More Information

Sponsor

M.D. Anderson Cancer Center

Last update posted

Nov 14, 2023

Last verified

Nov, 2023

Trial information was received from ClinicalTrials.gov and was last updated on 2026-09-08. This information was provided to ClinicalTrials.gov by M.D. Anderson Cancer Center on 2023-11-14.