This is a non-interventional, multi-national, observational, prospective patient registry to further evaluate the effectiveness and safety of dinutuximab beta - a monoclonal immunoglobulin G 1 (IgG1) antibody, to obtain information on survival, pain severity and incidence of neuro-toxicity, visual impairment, capillary leak syndrome, cardiovascular events, hypersensitivity reactions and long-term safety.
Patients diagnosed with high-risk neuroblastoma and starting treatment with commercially available dinutuximab beta OR
Patients diagnosed with high-risk neuroblastoma and starting treatment with dinutuximab beta in a clinical trial where dinutuximab beta is provided according to the country/regional marketing authorisation AND
Appropriate consent/assent has been obtained for participation in the registry with a willingness to be followed up for up to 10 years.
Patients commencing dinutuximab beta within a clinical trial where the product is being provided outside of the country/regional marketing authorisation OR
Appropriate consent/assent has not been obtained for participation in the registry or patient/legal representative is not willing for the patient be followed up for up to 10 years.
Patients diagnosed with high-risk neuroblastoma who are starting treatment with dinutuximab beta in the standard clinical practice setting or participating in a clinical trial where dinutuximab beta is provided according to the indication as per the country/regional marketing authorisation, provide consent/assent and are willing to be followed up for up to 10 years. Centers who treat neuroblastoma patients with dinutuximab beta will be invited to participate in the registry. This includes networks such as the Society of Paediatric Oncology for the Treatment of Neuroblastoma (SIOPEN) in Europe.
Cohort
Prospective
Data-collection
Other interventionData will be collected on dose, total cumulative amount of dinutuximab beta per course, dose interruptions, dose discontinuations, prophylactic treatment, use of all concomitant analgesia, assessments of pain, and occurrence of neurotoxicity, visual impairment, capillary leak syndrome, cardiovascular events and hypersensitivity reactions and other AEs.
Assessment of the severity of pain experienced by participants during treatment with dinutuximab beta
Assessment of pain severity experienced by participants during the period of first dose of dinutuximab beta to the end of last 35 day course of 5th cycle of treatment
Number of participants using analgesics during treatment with dinutuximab beta
Use of analgesics during the period of first dose of dinutuximab beta to end of last 35 day course of 5th cycle of treatment
Incidence of neurotoxicity, visual impairment, capillary leak syndrome, cardiovascular events and hypersensitivity reactions
Incidence of neurotoxicity, visual impairment, capillary leak syndrome, cardiovascular events and hypersensitivity reactions up to the end of the last 35 day course of 5th cycle of treatment
Number of participants experiencing serious adverse events (SAEs) and adverse drug reactions (ADRs) during treatment with dinutuximab beta
Number of participants experiencing serious adverse events (SAEs) and adverse drug reactions (ADRs) following the end of the last 35 day course of 5th cycle of treatment
Overall Survival (OS)
Overall Survival (OS) following the end of the last 35 day course of 5th cycle of treatment
Progression free survival (PFS)
Progression free survival (PFS) following the end of the last 35 day course of 5th cycle of treatment
Event Free Survival (EFS)
Event Free Survival (EFS) following the end of the last 35 day course of 5th cycle of treatment
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RECORDATI GROUP
Lead sponsor
United BioSource, LLC
Collaborator
