Clinical trial NCT05130489: CAR T Cell Therapy Related Cardiovascular Outcomes
Official title: Chimeric Antigen Receptor (CAR) Cell Therapy Related Cardiovascular Outcomes
Study type: OBSERVATIONAL
Overall status: COMPLETED
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
Lead sponsor: University College London Hospitals
Sponsor class: OTHER
First posted: 2021-11-23
Enrollment: 150
Sex: ALL
Minimum age (years): 16
Standard ages: CHILD
ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: COHORT
Time perspective: PROSPECTIVE
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.

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.

Detailed description: CD19-specific chimeric antigen receptor (CAR) T cells are a novel therapy for relapsing or refractory blood cancers, which have delivered a significant improvement in the rates of complete and partial remission. However, they are associated with toxicities, with some of early evidence suggestive of cardiovascular involvement. Despite this, the full extent of cardiovascular toxicity is poorly understood.

This research study seeks to understand the cardiac safety of CAR T cells in patients who receive this therapy as part of standard care for relapsed/refractory B-cell blood cancer. They will be assessed for cardiovascular risk factors via history, blood biomarkers, and cardiac imaging tests. These parameters will be repeated at 7 days following administration of the CAR T cells or if there are signs of cardiovascular deterioration, and again at 3 months follow up.

The aim is to predict the cohort most at risk of cardiovascular toxicity, and demonstrate evidence of cardiac injury on the cardiac imaging scans.

Eligibility criteria: Inclusion Criteria:

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

Exclusion Criteria:

* Patients under 16 years

Primary outcomes:
measure: Detected abnormalities - Composite
timeFrame: 3 months
Secondary outcomes:
measure: Detected abnormalities - Individual
timeFrame: 3 months
Other outcomes:
Locations:
city: London
country: United Kingdom
facility: University College London Hospitals
Study officials:
References: