Using cardiac MRI to study heart effects in patients receiving CAR T-cell therapy
Multiparametric Cardiac MRI in Oncological Patients Under Chimeric Antigen Receptor T-Cell Therapy
University Hospital, Bonn · NCT05414162
This study is testing how CAR T-cell therapy affects heart health in patients with blood cancers like DLBCL and multiple myeloma by using cardiac MRI to look for any heart problems during and after treatment.
Quick facts
| Study type | Observational |
|---|---|
| Enrollment | 60 (estimated) |
| Ages | 18 Years and up |
| Sex | All |
| Sponsor | University Hospital, Bonn (other) |
| Drugs / interventions | CAR T, chimeric antigen receptor, chemotherapy, cyclophosphamide, fludarabine |
| Locations | 1 site (Bonn, NRW) |
| Trial ID | NCT05414162 on ClinicalTrials.gov |
What this trial studies
This observational study aims to investigate the cardiovascular effects of CAR T-cell therapy in patients with hematological malignancies such as DLBCL and multiple myeloma. By employing cardiac MRI, the study will monitor both acute and long-term impacts on heart muscle health in individuals undergoing this innovative treatment. The research seeks to fill the gap in understanding the potential cardiotoxicity associated with CAR T-cell therapy, particularly in relation to cytokine release syndrome and myocarditis. Participants will be closely evaluated through systematic cardiac imaging and clinical assessments.
Who should consider this trial
Good fit: Ideal candidates for this study are patients scheduled to receive CAR T-cell therapy for conditions like DLBCL or multiple myeloma.
Not a fit: Patients with pre-existing significant cardiac conditions or those unable to undergo MRI due to medical devices or claustrophobia may not benefit from this study.
Why it matters
Potential benefit: If successful, this study could enhance the understanding of heart-related complications in patients undergoing CAR T-cell therapy, leading to improved patient management and outcomes.
How similar studies have performed: While studies on CAR T-cell therapy have been conducted, this specific approach using cardiac MRI to assess heart effects is relatively novel and underexplored.
Eligibility criteria
Show full inclusion / exclusion criteria
Inclusion Criteria: * Patients undergoing CAR T-cell therapy * Consent to participate in study Exclusion Criteria: * Inability to undergo MRI examinations due to large metallic implants, cardiac pacemakers/neurostimulators, or claustrophobia * Known cardiac conditions such as status post heart attack or myocarditis, complex congenital heard disease, or cardiomyopathies. * Birth control using an IUD. * Pregnancy or breastfeeding. * Renal insufficiency with a GFR below 30 ml/min/1.73m2
Where this trial is running
Bonn, NRW
- University Hospital Bonn — Bonn, NRW, Germany (RECRUITING)
Study contacts
- Principal investigator: Julian Luetkens, MD — University Hospital, Bonn
- Study coordinator: Julian Luetkens, MD
- Email: julian.luetkens@ukbonn.de
- Phone: +49 228 287 11831
How to participate
- Review the eligibility criteria above with your treating physician.
- Visit the official trial page on ClinicalTrials.gov for the most current contact information and recruitment status.
- Contact the listed study coordinator or principal investigator to request pre-screening. Pre-screening is free and never obligates you to enroll.
Conditions: DLBCL, Multiple Myeloma, Cytokine Release Syndrome, Myocarditis, CAR T-cell Therapy, ALL, PCBCL, Follicular Lymphoma