C83.3 C90 C82 C91 C83.1
Conditions
Interventions
Group 1: The study will follow a structured timeline aligned with the clinical treatment and follow-up course of patients undergoing CAR T-cell therapy. Procedures will be scheduled to coincide with s
Sponsors
Universitätsklinik für Hämatologie, Onkologie und Zelltherapie
Eligibility
Sex/Gender
All
Age
18 Years to No maximum
Inclusion criteria
Inclusion criteria: - Diagnosis of hematologic malignancy for which CAR T-cell therapy is indicated - Scheduled treatment with approved CAR T-cell therapy - Able to provide informed consent and participate in neurocognitive testing - German proficiency sufficient to complete validated neuropsychological measures (or validated translated tools available) - Availability for follow-up over a minimum of 6-month post-infusion period
Exclusion criteria
Exclusion criteria: - Pre-existing moderate to severe neurocognitive impairment (e.g. dementia) - Active central nervous system (CNS) involvement by disease (e.g. CNS or leptomeningeal infiltration) - Significant psychiatric conditions (e.g. schizophrenia, severe affective disorder, substance abuse) that may confound cognitive data - Severe sensory or motor deficits impeding test completion - Contraindications to MRI examinations as per standard screening guidelines - Enrollment in other interventional studies
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| - Clinically-reported cognitive tests at 3-, 6-, and 12-months post-infusion - High-resolution magnetic resonance imaging (MRI) within 2 weeks, at 6, months and 12 months post-infusion - Kinetic measurement of circulating biomarkers associated with neuroinflammation in patient se-ra at the early, intermediate and late phase post-infusion | — |
Secondary
| Measure | Time frame |
|---|---|
| - Clinically-reported cognitive tests and patient-reported fatigue assessment at 7 days post-infusion - PROMs at 3-, 6-, and 12-months post-infusion - Qualitative and quantitative evaluation of video-electroencephalography (EEG) monitoring (VEM) in wakefulness and sleep at 12 months post-infusion - Longitudinal assessment of circulating inflammatory biomarkers and immune cell populations in patient peripheral blood at the early, intermediate and late phase post-infusion - Kinetic measurement of circulating immunological biomarkers associated with neuroinflammation in patient sera at the early, intermediate and late phase post-infusion - Kinetic measurement of circulating biomarkers associated with cognition at the early, intermediate and late phase post-infusion - Measurement of absolute values and patterns of peripheral blood hematological and biochemical parameters at the early, intermediate and late phase post-infusion, as part of standard of care - Exploratory identification of predictive parameters for neurocognitive outcomes based on sub-group analyses of patients with/without ICANS, including correlations between biomarker pro-files, psychometric measures and imaging findings - Incidence and severity of AEs and laboratory abnormalities, including cytokine release syndrome (CRS) and ICANS frequency and grading | — |
Countries
Germany
Contacts
Public ContactDimitrios Katsaros
Universitätsklinik für Hämatologie, Onkologie und Zelltherapie
Outcome results
None listed