Patient Registry to Observe Safety and Outcomes in High-risk Neuroblastoma Patients Treated with the Monoclonal Antibody Dinutuximab Beta

What this Trial Is About

Neuroblastoma is the most common solid tumor outside the brain in children, often diagnosed before age 5 with many cases showing advanced or high-risk disease. Despite intensive treatments like high-dose chemotherapy and stem cell transplantation, outcomes remain poor. Researchers are evaluating the safety and effectiveness of dinutuximab beta, a monoclonal antibody targeting a molecule on neuroblastoma cells, in a large observational registry to gain more information on survival, pain, and various side effects. This registry follows patients with high-risk neuroblastoma who are treated with dinutuximab beta as part of standard care or clinical trials aligned with approved uses. Data collected include doses given, use of other medications like interleukin 2 and analgesics, and any side effects such as neurotoxicity, visual problems, capillary leak syndrome, cardiovascular events, and allergic reactions. The treatment period covers up to five 35-day cycles, with follow-up extending for up to 10 years to monitor long-term safety. Participants will have their medical data recorded at baseline, during treatment cycles, and through routine follow-up visits using electronic forms. Researchers assess pain severity, medication use for pain, adverse events, progression of disease, and survival outcomes. The study aims to enroll about 125 patients, tracking detailed safety and effectiveness information over many years to improve understanding of dinutuximab beta's impact in real-world use.

A Post-Authorisation Safety Study Patient Registry of Patients With Neuroblastoma Being Treated With Dinutuximab Beta