Actively Recruiting
PRONTO Trial (PRophylactic Versus ON-demand Use of TOcilizumab)
Led by Insel Gruppe AG, University Hospital Bern · Updated on 2024-07-08
100
Participants Needed
1
Research Sites
152 weeks
Total Duration
On this page
AI-Summary
What this Trial Is About
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.
CONDITIONS
Official Title
PRONTO Trial (PRophylactic Versus ON-demand Use of TOcilizumab)
Who Can Participate
Eligibility Criteria
You may qualify if you...
- Patients planned to receive commercial CAR-T treatment for lymphoma, leukemia, or myeloma at Bern Inselspital
- Provided written informed consent
- Considered clinically fit for CAR-T treatment by the investigator
- Aged 18 years or older
You will not qualify if you...
- Previous Tocilizumab treatment within 3 months prior to CAR-T infusion
- Treatment with an investigational drug within 8 weeks before CAR-T infusion
- Women who are pregnant, breastfeeding, or planning pregnancy during the study without safe contraception
- Inability to follow study procedures due to language, psychological, or cognitive issues
- Previous participation in this study
- Investigator or family members or employees involved in the study
AI-Screening
AI-Powered Screening
Complete this quick 3-step screening to check your eligibility
Trial Site Locations
Total: 1 location
1
Insel Gruppe AG
Bern, Canton of Bern, Switzerland, 3010
Actively Recruiting
Research Team
T
Thomas Pabst, Prof.
CONTACT
How is the study designed?
Study Type
INTERVENTIONAL
Masking
NONE
Allocation
RANDOMIZED
Model
PARALLEL
Primary Purpose
TREATMENT
Number of Arms
2
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