Registry for patients with high-risk neuroblastoma treated with dinutuximab beta
A Post-Authorisation Safety Study Patient Registry of Patients With High-risk Neuroblastoma Being Treated With the Monoclonal Antibody Dinutuximab Beta
This study is testing how safe and effective a treatment called dinutuximab beta is for children with high-risk neuroblastoma.
Quick facts
| Study type | Observational |
|---|---|
| Enrollment | 125 (estimated) |
| Ages | 1 Year to 18 Years |
| Sex | All |
| Sponsor | Recordati Group Industry-sponsored |
| Drugs / interventions | dinutuximab, chemotherapy |
| Locations | 13 sites (Vienna, State of Vienna and 12 other locations) |
| Trial ID | NCT04253015 on ClinicalTrials.gov |
What this trial studies
This observational registry aims to evaluate the safety and effectiveness of dinutuximab beta, a monoclonal antibody used in treating high-risk neuroblastoma in children. It collects data on various outcomes, including survival rates, pain severity, and potential side effects such as neurotoxicity and cardiovascular events. The study involves patients diagnosed with high-risk neuroblastoma who are starting treatment with dinutuximab beta, either commercially or in a clinical trial. Participants will be followed for up to 10 years to gather long-term safety and efficacy data.
Who should consider this trial
Good fit: Ideal candidates are children diagnosed with high-risk neuroblastoma who are beginning treatment with dinutuximab beta.
Not a fit: Patients receiving dinutuximab beta outside of the approved marketing authorization or those who cannot provide consent will not benefit from this study.
Why it matters
Potential benefit: If successful, this registry could provide valuable insights into the long-term safety and effectiveness of dinutuximab beta, potentially improving treatment strategies for neuroblastoma.
How similar studies have performed: Previous studies have shown promising results with dinutuximab beta in treating neuroblastoma, indicating that this registry builds on established findings.
Eligibility criteria
Show full inclusion / exclusion criteria
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.
Where this trial is running
Vienna, State of Vienna and 12 other locations
- St. Anna Kinderkrebsforschung — Vienna, State of Vienna, Austria (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, United Kingdom (Recruiting)
- Birmingham Children's Hospital — Birmingham, United Kingdom (Active_not_recruiting)
- University Hospital Southampton — Southampton, United Kingdom (Recruiting)
Study contacts
- Study coordinator: Jose-Luis Garcia
- Email: PASS@eusapharma.com
- Phone: +34 663 36 34 24
How to participate
- Review the eligibility criteria above with your treating physician.
- Visit the official trial page on ClinicalTrials.gov for the most current contact information and recruitment status.
- Contact the listed study coordinator or principal investigator to request pre-screening. Pre-screening is free and never obligates you to enroll.