Tumor patients with B-cell lymphomas, leukemias, NSCLC, metastatic melanoma, breast cancer, head-and-neck tumors or urologic tumors who are receiving system therapy with or without immunotherapy C00-C14 C34 C43-C44 C64-C68 C50
Conditions
Interventions
Group 1: Immunotherapy (starting after baseline visit
observation up to 18 months during treatment)
Group 2: No immunotherapy prior to or during the study participation (physician's choice
observation up to 18 months during treatment)
Sponsors
Universitätsklinikum Jena
Eligibility
Sex/Gender
All
Age
18 Years to No maximum
Inclusion criteria
Inclusion criteria: Inclusion Criteria CAR-T Cell Cohort: • Age = 18 years, of either female or male gender • Ability to provide consent or presence of a legal guardian • Informed consent available • Histologically confirmed hematologic neoplasm with an approved indication for treatment with CAR-T cells in Germany at the time of individual recruitment (e.g., B-cell lymphoma, leukemias) • Indication for CAR-T cell therapy in the hematology-oncology tumor board & planned treatment at UKJ • ECOG status 0-2 / Karnofsky index > 50% • MRI suitability given • No known gadolinium intolerance/contraindication Inclusion Criteria Physician’s Choice Cohort (NTox-PARTICIPATE Control Group): • Age = 18 years, of either female or male gender • Ability to provide consent or presence of a legal guardian • Informed consent available • Presence of bronchial carcinoma, metastatic melanoma, urological, GI, or head and neck tumor (preferably “matched pairs” strategy regarding therapy line and entity, especially for patients in the CAR-T cell target cohort; high suspicion or histologically confirmed neoplasm) • Indication for oncological systemic therapy (excluding immunotherapies!) & planned treatment at UKJ • No prior or concurrent ICI/CAR-T cell therapy planned • ECOG status 0-2 / Karnofsky index > 50% • MRI suitability given • No known gadolinium intolerance/contraindication • No permanent intake of steroids > 8 mg dexamethasone or equivalent Inclusion Criteria Validation Data (CON Patients): • Age = 18 years, of either female or male gender • Ability to provide consent or presence of a legal guardian • Informed consent via UKJ information / Medical Informatics Initiative from routine treatment available • Presentation at the neurology clinic with suspected neurological side effect under immunotherapy • Examination findings from routine treatment (especially lab parameters and clinical assessments) or residual materials available that can be used as a comparison for patients with neurological side effects from longitudinal data collection
Exclusion criteria
Exclusion criteria: • No informed consent available • Simultaneous participation in an interventional clinical trial • Presence of other tumor diseases requiring treatment with positive lymph node status or metastasis (including the imminent exclusive necessity for radiation or surgery), except for the systemically treated entity; exceptions include treated prostate cancer with PSA 32 kg/m² b. post pacemaker implantation c. non-MRI-compatible implants, e.g., port system • Known gadolinium intolerance/contraindication • Pregnancy or breastfeeding • Presence of an infectious disease that is contagious (especially HIV, hepatitis B or C) at the time of study enrollment
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| The primary objective of the study is to characterize morphological abnormalities associated with immunotherapy-induced neurological symptoms during immunotherapy. Patients will be examined prior to therapy and at 6 time points during the 12 months of systemic treatment (baseline, 7-14 days, 6 weeks, 3 months, 6 months, 12 months after study inclusion) using the multimodal diagnostic concept of the study (observation phase). Subsequently, a one-time follow-up is carried out after 6 months on the basis of the patient files for the final documentation of the oncological course and neurological outcome. Primary outcome: • Presence of morphological changes in patients with immunotherapy-associated neurological deterioration at the time of onset and within 12 months after the start of immunotherapy - Change in NANO / EDSS / TNS and MRI category / sonography score - Change in MMST / ICE / MOCA and MRI category | — |
Secondary
| Measure | Time frame |
|---|---|
| The secondary objectives of the study are to provide further clinical and immunological characterization of immunotherapy neurotoxicity in relation to neurological co-morbidity, age, other/systemic side effects of immunotherapies, and in comparison to neurologically not affected patients on immunotherapies and the control group. Secondary outcomes: • Presence of morphological changes in patients without confirmed immunotherapy-associated neurological deterioration within 12 months after initiation of immunotherapy - Change NANO / EDSS and MRI category / sonography score - Change in TNS and MRI category / sonography score - Change in ICE/MOCA and MRI category • Presence of morphological changes in patients without immunotherapy (control group) within 12 months after the start of immunotherapy compared to the immunotherapy group and patients with neurotoxicity - Change NANO / EDSS and MRI category / sonography score - Change in TNS and MRI category / sonography score - Change in ICE/MOCA and MRI category • Type and time of occurence of other therapy-associated adverse events and their association with the occurrence of neurological immunotherapy-associated symptoms • Comparison of MRI and HRUS changes depending on the age of the study participants | — |
Countries
Germany
Contacts
Public ContactIrina Mäurer
Universitätsklinikum Jena, Klinik für Neurologie, AG Neurotoxizität und Neuroonkologie
Outcome results
None listed