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RECRUITING
NCT04253015

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

Sponsor: RECORDATI GROUP

View on ClinicalTrials.gov

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.

Official title: A Post-Authorisation Safety Study Patient Registry of Patients With High-risk Neuroblastoma Being Treated With the Monoclonal Antibody Dinutuximab Beta

Key Details

Gender

All

Age Range

1 Year - 18 Years

Study Type

OBSERVATIONAL

Enrollment

125

Start Date

2019-09-30

Completion Date

2032-06-15

Last Updated

2024-02-07

Healthy Volunteers

No

Conditions

Interventions

OTHER

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.

Locations (13)

St. Anna Kinderkrebsforschung

Vienna, 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