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

NCT04253015 · tracked via the Priya Life Science Italy tracker

Sponsor

RECORDATI GROUP

Phase

Observational

Started

2019-09-30

Last updated

2024-02-07

Condition(s) studied

Neuroblastoma

Investigational drug(s) / intervention(s)

Data-collection

Data-collection: Data 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.

Study summary

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.

Eligibility

Sex

ALL

Min age

1 Year

Max age

18 Years

Healthy volunteers

Inclusion Criteria: Patients meeting the following criteria will be considered for inclusion into the registry: * 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. Exclusion Criteria: Patient will not be eligible for inclusion if the following criterion applies: * 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.

Primary outcome measure(s)

Assessment of the severity of pain experienced by participants during treatment with dinutuximab beta — First dose of dinutuximab beta to the end of the last 35 day course of the 5th cycle of treatment (each cycle is 35 days)
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 — First dose of dinutuximab beta to the end of the last 35 day course of the 5th cycle of treatment (each cycle is 35 days)
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 — First dose of dinutuximab beta to the end of the last 35 day course of the 5th cycle of treatment (each cycle is 35 days)
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 — First dose of dinutuximab beta to the end of the last 35 day course of the 5th cycle of treatment (each cycle is 35 days)
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

Trial sites (13)

Facility	City	Region	Status
St. Anna Kinderkrebsforschung	Vienna	State of Vienna	Active Not Recruiting
Centre Oscar Lambret	Lille	France	Recruiting
Hôpital de la Timone, Hôpital des Enfants	Marseille	France	Recruiting
Institut Curie	Paris	France	Active Not Recruiting
Institut Gustave Roussy	Villejuif	France	Recruiting
Charité Berlin	Berlin	Germany	Recruiting
Universitätsmedizin Greifswald	Greifswald	Germany	Recruiting
IRCCS Istituto Giannina Gaslini	Genova	Italy	Recruiting
Uniwersytecki Szpital Dziecięcy	Krakow	Poland	Recruiting
Hospital Universitario y Politecnico La Fe Avenida Fernando Abril Martorell	Valencia	Spain	Recruiting
The Newcastle upon Tyne Hospitals NHS Foundation Trust	Newcastle upon Tyne	Newcastle	Recruiting
Birmingham Children's Hospital	Birmingham	United Kingdom	Active Not Recruiting
University Hospital Southampton	Southampton	United Kingdom	Recruiting

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Official registry record

This page summarises publicly available registry data for informational purposes — not medical advice. Eligibility is determined by each study team; patients should discuss participation with their clinician.

View NCT04253015 on ClinicalTrials.gov ↗ ← All trials in Italy