CAR T Cell Therapy Related Cardiovascular Outcomes

NCT05130489 | Completed

• 1 other identifier: 20/SC/0301
• Study Type: observational
• Target: 150
• Locations: 1 country
• Sites: 1

Brief Summary

This will be a cohort study of all patients receiving Cluster of Differentiation 19 (CD19)-specific CAR T cell therapy for relapsed/refractory B cell haematological malignancies. Patients will receive cardiac assessment and have serum cardiac biomarkers, ECG, transthoracic echocardiogram and cardiac magnetic resonance imaging performed at baseline prior to CAR T cell therapy, 7 days post CAR T cell infusion, and 3 months post CAR T cell infusion. Abnormalities in these cardiac investigations will be used to demonstrate cardiac injury and identify which patients are most at risk of developing cardiac injury related to CAR T cell therapy.

Conditions

Cardiovascular Diseases; B-cell Acute Lymphoblastic Leukemia; B-cell Lymphoma Refractory; B-cell Lymphoma Recurrent; Primary Mediastinal Large B-cell Lymphoma (PMBCL); Diffuse Large B Cell Lymphoma; Cardiotoxicity; Cardiovascular Complication

Keywords

Cardio-oncology; CAR T cell therapy; Cardiotoxicity

Outcome Measures

Primary Outcomes (1)

• Detected abnormalities - Composite

  The primary outcome is a composite of detected abnormalities on biomarkers, transthoracic echocardiogram (TTE), or Cardiac magnetic resonance (CMR) following CAR T cell infusion.

  3 months

Secondary Outcomes (1)

• Detected abnormalities - Individual

  3 months

Eligibility Criteria

• Age: 16 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17), Adult (18-64), Older Adult (65+)
• Sampling Method: Non-Probability Sample

Study Population

All patients receiving CD19-specific CAR T cell therapy for the management of relapsing or refractory haematological malignancy at the MacMillan Cancer Centre within the University College London Hospital will be considered for participation.

You may qualify if:

• Patients with capacity, (aged 16 and older)
• Undergoing CAR T cells for treatment for relapsing or refractory haematological malignancies

You may not qualify if:

• Patients under 16 years

Sponsors & Collaborators

• University College London Hospitals: lead

Study Sites (1)

University College London Hospitals

London, United Kingdom

Location

Biospecimen

Retention: SAMPLES WITHOUT DNA

Blood serum will be separated from whole blood and retained for follow-on analysis.

MeSH Terms

Conditions

Cardiovascular Diseases; Burkitt Lymphoma; Lymphoma, Large B-Cell, Diffuse; Cardiotoxicity

Condition Hierarchy (Ancestors)

Epstein-Barr Virus Infections; Herpesviridae Infections; DNA Virus Infections; Virus Diseases; Infections; Tumor Virus Infections; Lymphoma, B-Cell; Lymphoma, Non-Hodgkin; Lymphoma; Neoplasms by Histologic Type; Neoplasms; Lymphoproliferative Disorders; Lymphatic Diseases; Hemic and Lymphatic Diseases; Immunoproliferative Disorders; Immune System Diseases; Heart Diseases; Pathologic Processes; Pathological Conditions, Signs and Symptoms; Drug-Related Side Effects and Adverse Reactions; Chemically-Induced Disorders; Radiation Injuries; Wounds and Injuries

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: PROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Professor

Study Record Dates

• First Submitted: November 4, 2021
• First Posted: November 23, 2021
• Study Start: January 18, 2021
• Primary Completion: March 1, 2023
• Study Completion: May 1, 2023
• Last Updated: May 12, 2023

Record last verified: 2023-05

Data Sharing

• IPD Sharing: Will not share

Locations

GB (1)