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

NCT ID: NCT04870853

Last Updated: 2023-11-14

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

RECRUITING

Total Enrollment

150 participants

Study Classification

OBSERVATIONAL

Study Start Date

2020-04-02

Study Completion Date

2025-01-30

Brief Summary

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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.

Detailed Description

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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.

Conditions

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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 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 Refractory Transformed Follicular Lymphoma to Diffuse Large B-Cell Lymphoma

Study Design

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Observational Model Type

COHORT

Study Time Perspective

RETROSPECTIVE

Study Groups

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Observational (medical record review)

Patients' medical records are reviewed retrospectively.

Electronic Health Record Review

Intervention Type OTHER

Medical records reviewed

Interventions

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Electronic Health Record Review

Medical records reviewed

Intervention Type OTHER

Eligibility Criteria

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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
Minimum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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M.D. Anderson Cancer Center

OTHER

Sponsor Role lead

Responsible Party

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Responsibility Role SPONSOR

Principal Investigators

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Raphael E Steiner

Role: PRINCIPAL_INVESTIGATOR

M.D. Anderson Cancer Center

Locations

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M D Anderson Cancer Center

Houston, Texas, United States

Site Status RECRUITING

Countries

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United States

Facility Contacts

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Raphael E. Steiner

Role: primary

713-792-2860

Other Identifiers

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NCI-2021-02675

Identifier Type: REGISTRY

Identifier Source: secondary_id

2020-0120

Identifier Type: OTHER

Identifier Source: secondary_id

2020-0120

Identifier Type: -

Identifier Source: org_study_id

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