About this trial
Despite the consequent use of Tocilizumab together with conventional antipyretics at early/first signs of emerging CRS, CRS (and eventually the subsequent development of ICANS) remain a major concern for patients.
This study aims to identify safety and efficacy of prophylactic Tocilizumab treatment. In particular, to explore whether prophylactic Tocilizumab treatment can decrease the incidence and severity of CRS (and subsequent eventual neurotoxicity) following CAR-T-treatment.
Eligibility criteria
This trial does not accept healthy volunteersQualifiers
Patients planned to receive commercial CAR-T treatment for all registered indications comprising lymphomas, leukemias or myeloma at a single academic center (Bern Inselspital)
With written informed consent
Considered by the investigator to be clinically fit for this treatment
Patients aged ≥18 years
Disqualifiers
Previous Tocilizumab treatment within 3 months prior to CAR-T infusion
Patients with treatment with an investigational compound within 8 weeks prior to CAR-T infusion
Women who are pregnant or breast feeding, or women intending to become pregnant during the study period; or participants lacking safe contraception, defined as: Female participants of childbearing potential, not using and not willing to continue using a medically reliable method of contraception for the entire study duration, such as oral, injectable, or implantable contraceptives, or intrauterine contraceptive devices, or who are not using any other method considered sufficiently reliable by the investigator in individual cases during study treatment and for a total of 12 months; Female participants who are surgically sterilised / hysterectomised or post-menopausal for longer than 2 years are not considered as being of child bearing potential.
Inability to follow the procedures of the study, e.g. due to language problems, psychological disorders, dementia, etc. of the participant
Trial design
Parallel
Treatments tested in this trial
Tocilizumab before CAR-T cell infusion
DrugTocilizumab will be given at the standard-dose of 8 mg/kg b.w. intravenously, with completion of the infusion 1 hour prior to infusion of CAR-T cells. Treatment of eventual subsequent CRS/ICANS will be identical as in patients in the standard arm.
Tocilizumab at emerging CRS
DrugTocilizumab will be given at the standard-dose of 8 mg/kg b.w. intravenously, and it will be repeated after 8 hours for a maximum of four administrations in patients with ongoing signs of CRS.
Treatment groups
Trial outcomes
Primary outcomes
Incidence of CRS of all grades
Number of patients with CRS of any grade according to the ASTCT (American Society for Transplantation and Cellular Therapy ) Consensus Grading for Cytokine Release Syndrome and Neurologic Toxicity Associated with Immune Effector Cells ; including use of antipyretics
Secondary outcomes
Incidence of ICANS of all grades
Number of patients with ICANS of any grade according to the ASTCT Consensus Grading for Cytokine Release Syndrome and Neurologic Toxicity Associated with Immune Effector Cells ; including use of antipyretics
Hospitalization duration
Number of days from admission to discharge from hospital
Erythrocyte transfusion needs
Number of transfusion (erythrocyte) given
Platelet transfusion needs
Number of transfusion (platelet) given
Sponsors and contacts
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