Clinical trial · Observational
CAR T Cell Therapy Related Cardiovascular Outcomes
Chimeric Antigen Receptor (CAR) Cell Therapy Related Cardiovascular Outcomes
- Source
- ClinicalTrials.gov
- Retrieved
- Sep 8, 2026
- Layer
- normalized (units and labels harmonized; values unchanged)
- Run
- ING-CLINICALTRIALS-20260908-000001
Summary
Brief summary (as posted)
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
Conditions (8)
Free-text conditions as registered, with the CancerIndex entity they were reconciled to and the match type.
| Condition (as posted) | Mapped entity | Match | Confidence |
|---|---|---|---|
| B-cell Acute Lymphoblastic Leukemia | B Acute Lymphoblastic Leukemia | ALIAS | 0.90 |
| B-cell Lymphoma Recurrent | — | UNRESOLVED | — |
| B-cell Lymphoma Refractory | — | UNRESOLVED | — |
| Cardiotoxicity | — | UNRESOLVED | — |
| Cardiovascular Complication | — | UNRESOLVED | — |
| Cardiovascular Diseases | — | UNRESOLVED | — |
| Diffuse Large B Cell Lymphoma | Diffuse Large B-Cell Lymphoma | CURATED_BROADER | 0.80 |
| Primary Mediastinal Large B-cell Lymphoma (PMBCL) | Primary Mediastinal Large B-Cell Lymphoma | ONTOLOGY_EXACT |
Interventions
Interventions (0)
Data not yet available
Design
Arms and outcomes
Arms (0)
[]Primary outcomes (1)
- measure
- Detected abnormalities - Composite
- timeFrame
- 3 months
- description
- The primary outcome is a composite of detected abnormalities on biomarkers, transthoracic echocardiogram (TTE), or Cardiac magnetic resonance (CMR) following CAR T cell infusion.
Secondary outcomes (1)
- measure
- Detected abnormalities - Individual
- timeFrame
- 3 months
- description
- The secondary outcome measures includes a composite of detected abnormalities of factors on cardiac biomarkers (troponin and N-terminal pro B-type natriuretic peptide) , electrocardiogram (ECG) changes and acute heart failure.
Eligibility
Eligibility (as posted)
- Sex
- All
- Minimum age
- 16 Years
Show eligibility criteria text
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
References
Publications (0)
Data not yet available