Multiple Myeloma Clinical Trial
Official title:
Multiparametric Cardiac MRI in Oncological Patients Under Chimeric Antigen Receptor T-Cell Therapy
NCT number | NCT05414162 |
Other study ID # | 81/22 |
Secondary ID | |
Status | Recruiting |
Phase | |
First received | |
Last updated | |
Start date | May 16, 2022 |
Est. completion date | December 2025 |
Recently chimeric antigen receptor (CAR) T-cell therapy, a new class of chemo therapy, has gained regulatory approval for the treatment of diseases such as B-cell lymphoma. Known side effects include cytokine release syndrome, which has been described to lead to myocarditis, but larger studies exploring this relationship are currently lacking. In this prospective study, the investigators aim to explore the potential effects of CAR T-cell therapy using cardiac MRI on the heart.
Status | Recruiting |
Enrollment | 60 |
Est. completion date | December 2025 |
Est. primary completion date | May 2024 |
Accepts healthy volunteers | |
Gender | All |
Age group | 18 Years and older |
Eligibility | 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 |
Country | Name | City | State |
---|---|---|---|
Germany | University Hospital Bonn | Bonn | NRW |
Lead Sponsor | Collaborator |
---|---|
University Hospital, Bonn |
Germany,
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* Note: There are 23 references in all — Click here to view all references
Type | Measure | Description | Time frame | Safety issue |
---|---|---|---|---|
Primary | Extent and pattern of acute cardiac effects of CAR T-cell therapy | To investigate to what extent and with which patterns CAR T cell therapy leads to acute cardiac effects in terms of inflammation, fibrosis, and myocardial dysfunction that can be detected with cardiac MRI. | 2 weeks | |
Primary | Long-term cardiac remodeling effects of CAR T-cell therapy | To explore whether CAR T cell therapy leads to long-term cardiac remodeling effects in terms of inflammation, fibrosis, and myocardial dysfunction that can be detected with cardiac MRI. | 6 months | |
Primary | Correlate MRI findings with clinical course | To assess whether changes in cardiac MRI parameters obtained from objectives 1 and 2 correlate with the clinical course (e.g., CRS development), cytokines and immunological markers and might predict major adverse cardiac events (MACE). | 6 months |
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