Clinical Trials in Poland / NCT04253015
Recruiting
Observational
A Post-Authorisation Safety Study Patient Registry of Patients With Neuroblastoma Being Treated With Dinutuximab Beta
NCT04253015 · tracked via the Priya Life Science Poland tracker
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
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 |
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 Poland