C83.3 C90.0 G04.2 G37.9 A85.8
Conditions
Interventions
Group 1: Patients who develop ICANS (immune effector cell associated neurotoxicity syndrome) after CAR-T cell therapy
Group 2: Patients without ICANS (immune effector cell associated neurotoxicity syn
Sponsors
Charité Universitätsmedizin Berlin, Klinik für Neurologie mit Experimenteller Neurologie
Eligibility
Sex/Gender
All
Age
18 Years to No maximum
Inclusion criteria
Inclusion criteria: - informed written consent - Patient is capable of giving consent (capable of understanding the nature and expected benefits and risks of the proposed investigations) - Minimum 18 years of age - sufficient health insurance coverage - Karnofsky Index =70% - The participant belongs to one of the following groups: # Patients/ patients with underlying hemato-oncologic disease for whom CAR T-cell therapy is planned. # Patients with malignant hemato-oncological disease (preferably lymphoma, leukemia, multiple myeloma) # healthy volunteers # Patients with suspected CNS infection undergoing diagnostic lumbar puncture # Patients with suspected or confirmed autoimmunological CNS disease undergoing diagnostic lumbar puncture. - For cohorts 1-3: fluent in written and spoken German language
Exclusion criteria
Exclusion criteria: - The patient is not willing to consent to the storage, processing and disclosure of pseudonymized medical data for study purposes - The patient is under legal care or lawfully placed in an official institution - To be applied for cohort 1-3 only: # The patient has pre-existing (dementia, identifiable by a MOCA score of <15/30 pts.) # The patient has a history of florid alcohol and/or drug abuse. # The patient is currently suffering from a moderately depressive episode (recognizable by a BDI-FS score of =4 pts.) # The patient has a pacemaker or a non-MRI capable implant.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Mean z-scores of different subtests of a standardized neuropsychological examination at V1 (baseline, approx. 1-4 weeks before CAR-T cell infusion) and at V3 (approx. 6 months after CAR-T cell infusion). The z-scores at V3, adjusted to the baseline level at V1, are compared between patients with ICANS and patients without ICANS. | — |
Secondary
| Measure | Time frame |
|---|---|
| 1. Long-term functional outcome: Comparison of modified Rankin Scale (mRS) and Barthel Index scores at V3 (6 months after CAR-T cell infusion) between patients with ICANS and control patients without ICANS. The mRS has a range from 0 to 5 points, the Barthel index from 0 to 100 points. 2. Quality of life in long-term outcome: Comparison of the score of the EORTC-QLQ-C30 at V3 (6 months after CAR-T cell infusion) between patients with ICANS and control patients without ICANS. The score has a range of 0 to 100 points. 3. Diagnostic/ predictive immunological markers: Comparison of cellular and non-cellular immunological markers in peripheral blood of patients with ICANS and control patients without ICANS. Immunocyte signatures in % of total lymphocyte count will be determined by mass spectrometry or flow cytometry and the concentration of different cytokines are measured in pg/ml. 4. Diagnostic/ predictive metabolic and neuroaxonal markers: Comparison of the serum concentration of metabolic markers (vitamins, trace elements) and serum concentrations of neuroaxonal/ glial damage markers between patients with ICANS and control patients without ICANS. 5. Diagnostic/ predictive genetic markers: Comparison of genetic markers (e.g. HLA type, CCR5 mutation) in peripheral blood of patients with ICANS and control patients without ICANS. The presence of a genomic marker is determined. 6. Diagnostic/ predictive EEG markers: Comparison of electroencephalographic findings of patients with ICANS and control patients without ICANS. The presence of diffuse brain dysfunction, regional brain dysfunction, epileptic potentials, triphasic waves, abnormal delta activity is assessed. 7. Immunological changes in cerebrospinal fluid: Comparison of cellular and non-cellular immunological markers in the cerebrospinal fluid (CSF) of patients with ICANS and patients with CNS infections and patients with autoimmune inflammatory CNS diseases. Immune cell signatures are determined in % | — |
Countries
Germany
Contacts
Public ContactPetra Hühnchen
Charité Universitätsmedizin Berlin, Klinik für Neurologie mit Experimenteller Neurologie
Outcome results
None listed