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Clinical Trials in the UK / NCT04253015
Active, not recruiting Observational

A Patient Registry of Patients With High-risk Neuroblastoma Being Treated With the Monoclonal Antibody Dinutuximab Beta

NCT04253015 · tracked via the Priya Life Science UK tracker
Sponsor
RECORDATI GROUP
Phase
Observational
Started
2019-09-30
Last updated
2026-10-26

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

Sex
ALL
Min age
1 Year
Max age
18 Years
Healthy volunteers
No
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)

FacilityCityRegionStatus
St. Anna Kinderkrebsforschung Vienna State of Vienna
Centre Oscar Lambret Lille France
Hôpital de la Timone, Hôpital des Enfants Marseille 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
Vall d'Hebron University Hospital Barcelona Spain
Hospital Universitario y Politecnico La Fe Avenida Fernando Abril Martorell Valencia Spain
The Newcastle upon Tyne Hospitals NHS Foundation Trust Newcastle upon Tyne Newcastle
Birmingham Children's Hospital Birmingham United Kingdom
University Hospital Southampton Southampton United Kingdom

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Other trials for the same condition

Naxitamab for High-Risk Neuroblastoma Patients With Primary Refractory Disease or Incomplete Response to Salvage Treatment in Bone and/or Bone Marrow Active, not recruiting
Substudy 01A: Zilovertamab Vedotin in Pediatric and Young Adult Participants With Hematologic Malignancies or Solid Tumors (MK-9999-01A/LIGHTBEAM-U01) Recruiting
A Study of LY3295668 Erbumine in Participants With Relapsed/Refractory Neuroblastoma Active, not 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 the UK