3 results
-To assess autonomic parasympathetic and sympathetic function as well as vascular function in a population of patients with univentricular hearts palliated by the Fontan procedure and compare it with the results in healthy subjects.-To assess the…
Primary: To evaluate the efficacy of tisagenlecleucel therapy as measured by overall response rate by investigator assessment.Secondary: Duration of response, event free survival, relapse free survival, overall survival, safety, kinetics,…
To compare tisagenlecleucel treatment strategy to SOC treatment strategy with respect to delaying the composite event of disease progression / stable disease at or after the week 12 assessment; or death at any time.