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

RecruitingOBSERVATIONAL
Enrollment

125

Participants

Timeline

Start Date

September 30, 2019

Primary Completion Date

March 31, 2032

Study Completion Date

June 15, 2032

Conditions
Neuroblastoma
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.

Trial Locations (13)

1090

ACTIVE_NOT_RECRUITING

St. Anna Kinderkrebsforschung, Vienna

13353

RECRUITING

Charité Berlin, Berlin

13385

RECRUITING

Hôpital de la Timone, Hôpital des Enfants, Marseille

16147

RECRUITING

IRCCS Istituto Giannina Gaslini, Genova

17475

RECRUITING

Universitätsmedizin Greifswald, Greifswald

46026

RECRUITING

Hospital Universitario y Politecnico La Fe Avenida Fernando Abril Martorell, Valencia

59000

RECRUITING

Centre Oscar Lambret, Lille

75005

ACTIVE_NOT_RECRUITING

Institut Curie, Paris

94805

RECRUITING

Institut Gustave Roussy, Villejuif

30-663

RECRUITING

Uniwersytecki Szpital Dziecięcy, Krakow

NE1 4LP

RECRUITING

The Newcastle upon Tyne Hospitals NHS Foundation Trust, Newcastle upon Tyne

B4 6NH

ACTIVE_NOT_RECRUITING

Birmingham Children's Hospital, Birmingham

SO16 6YD

RECRUITING

University Hospital Southampton, Southampton

All Listed Sponsors
collaborator

United BioSource, LLC

INDUSTRY

lead

RECORDATI GROUP

INDUSTRY