CAR-T Cell Therapy
Conditions
Interventions
Group 1: All patients with an indication for CAR-T cell therapy at the LMU Klinikum Munich, Germany, receive prehabilitative treatment (individualized exercise therapy, nutritional advice and psycho-o
Sponsors
LMU Klinikum München, Medizinische Klinik und Poliklinik III
Eligibility
Sex/Gender
All
Age
18 Years to No maximum
Inclusion criteria
Inclusion criteria: Patients with an indication for CAR-T cell therapy
Exclusion criteria
Exclusion criteria: - Lack of capacity to consent or being a minor at the time of study inclusion - Medical or mental condition which, in the opinion of the study team, does not allow the patient to participate in the study or to provide a legally valid signature on the informed consent form - Absolute contraindications against exercise therapy interventions: o Clinically manifest heart failure (NYHA III-IV) o Therapy-refractory arterial hypertension III-IV° o Respiratory insufficiency, severe COPD >III° o Therapy-refractory thrombocytopenia <10,000/µl, or coagulation disorders with clinically significantly increased risk of bleeding o Unstable coronary syndrome or unstable cardiac arrhythmia o Uncontrolled cerebral seizure disorder o Implanted pacemaker or defibrillator If the above-mentioned exercise therapy contraindications are present, inclusion in the study can still take place. These patients can participate in the psycho-oncological support program of the study and will be treated as a control group for exercise therapy. With the exception of exercise therapy, these patients will receive the same study program including all measurements, provided there are no contraindications for specific measurements (e.g. BIA with implanted pacemaker or defibrillator).
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Feasibility of prehabilitative, individualized exercise therapy and psycho-oncological support prior to CAR-T cell therapy | — |
Secondary
| Measure | Time frame |
|---|---|
| - Influence on immunometabolic parameters and their dynamics as well as immune cell recovery after CAR-T cell therapy - Influence on physical performance and body composition before and after CAR-T therapy - Influence on patient-reported outcomes before and after CAR-T cell therapy - What are the needs and burdens of CAR-T cell patients and their relatives? - Influence on the incidence and severity of infections - Duration of cytopenia after lymphodepletion - Tolerance (immunotoxicity) and response of the cancer to CAR-T cell therapy - Progression-free survival and overall survival | — |
Countries
Germany
Contacts
Public ContactSebastian Theurich Dr. med. Friederike Mumm
LMU Klinikum München, Medizinische Klinik und Poliklinik III
Outcome results
None listed