RecruitingNCT04253015

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


Sponsor

RECORDATI GROUP

Enrollment

125 participants

Start Date

Sep 30, 2019

Study Type

OBSERVATIONAL

Conditions

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

Min Age: 1 YearMax Age: 18 Years

Plain Language Summary

Simplified for easier understanding

This is a long-term safety registry tracking children and adults with high-risk neuroblastoma — a type of cancer that usually starts in the adrenal glands — who are being treated with a drug called dinutuximab beta. The registry collects data for up to 10 years to monitor safety and outcomes. **You may be eligible if:** - You (or your child) has been diagnosed with high-risk neuroblastoma - You are starting treatment with dinutuximab beta through commercial supply or via an approved clinical trial - You (or your child's guardian) are willing to be followed for up to 10 years **You may NOT be eligible if:** - The dinutuximab beta is being used in a clinical trial where the drug is supplied outside of its approved marketing authorization Talk to your doctor to see if this trial is right for you.

This summary was AI-generated to explain the trial in plain language. It is not medical advice. Always discuss eligibility with your doctor before enrolling in a clinical trial.

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Interventions

OTHERData-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.


Locations(13)

St. Anna Kinderkrebsforschung

Vienna, State of Vienna, Austria

Centre Oscar Lambret

Lille, France

Hôpital de la Timone, Hôpital des Enfants

Marseille, France

Institut Curie

Paris, France

Institut Gustave Roussy

Villejuif, France

Charité Berlin

Berlin, Germany

Universitätsmedizin Greifswald

Greifswald, Germany

IRCCS Istituto Giannina Gaslini

Genova, Italy

Uniwersytecki Szpital Dziecięcy

Krakow, Poland

Hospital Universitario y Politecnico La Fe Avenida Fernando Abril Martorell

Valencia, Spain

The Newcastle upon Tyne Hospitals NHS Foundation Trust

Newcastle upon Tyne, Newcastle, United Kingdom

Birmingham Children's Hospital

Birmingham, United Kingdom

University Hospital Southampton

Southampton, United Kingdom

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NCT04253015


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