drugset / Trial / NCT06430736

PRONTO Trial (PRophylactic Versus ON-demand Use of TOcilizumab)

NCT06430736

Phase 2 Recruiting 100 enrolled Insel Gruppe AG, University Hospital Bern
RandomizedParallel-groupOpen-labelTreatment

Summary

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.

Timeline

Start
2024-07-01
Primary completion
2026-12
Completion
2027-06

Drugs

EvaluationDrugModalityDoseRoute
Subject Tocilizumab Monoclonal antibody 8 mg/kg Intravenous