Hematological disease with an indication for CAR-T cell therapy
Conditions
Interventions
Group 1: Patients will undergo a physical-neurological and neuropsychological examination shortly before the start of therapy as a baseline assessment. As part of the standard evaluations, an MRI scan
Sponsors
Klinik und Poliklinik für Neurologie, Universitätsmedizin Mainz
Eligibility
Sex/Gender
All
Age
18 Years to No maximum
Inclusion criteria
Inclusion criteria: - Therapy with CAR-T-cells - age over 18 years
Exclusion criteria
Exclusion criteria: - Patients incapable of giving consent - CNS involvement due to an underlying malignant disease - Tumor recurrence after CAR-T cell therapy - Factors that contraindicate follow-up examinations within the study, e.g., current pregnancy, active alcohol abuse, pacemaker, claustrophobia, implants not compatible with MRI
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| The primary endpoint is the impact of CAR T-cell therapy on the central nervous system. - newly occurring neurological disorders identified in the physical examination - newly occurring cognitive deficits and fatigue symptoms identified in neuropsychological tests and questionnaires | — |
Secondary
| Measure | Time frame |
|---|---|
| - newly occurring lesions, volumetric changes, or alterations of the white matter in cerebral MRI (cMRI) - new changes in potential biomarkers (NFL and GFAP) in the blood | — |
Countries
Germany
Contacts
Public ContactStefan Bittner
Klinik und Poliklinik für Neurologie
Outcome results
None listed