Clinical trial · Observational
Post-Marketing Assessment of Immunogenicity and Safety of Unituxin® in High-Risk Neuroblastoma Patients
A Post-Marketing Study to Further Assess the Immunogenicity and Safety of Unituxin® in High-Risk Neuroblastoma Patients
NCT02693171CI-TRIAL-00039878terminatedResults postedClinicalTrials.gov clinicaltrialsProvenance
- Source
- ClinicalTrials.gov
- Retrieved
- Sep 8, 2026
- Layer
- normalized (units and labels harmonized; values unchanged)
- Run
- ING-CLINICALTRIALS-20260908-000001
Why stopped (as posted): Sponsor decision
Summary
Brief summary (as posted)
The purpose of this study was to assess the incidence of human anti-chimeric antibody (HACA) in high-risk neuroblastoma patients treated with Unituxin combination therapy.
Conditions
Conditions (1)
Free-text conditions as registered, with the CancerIndex entity they were reconciled to and the match type.
| Condition (as posted) | Mapped entity | Match | Confidence |
|---|---|---|---|
| Neuroblastoma | Neuroblastoma | ONTOLOGY_EXACT | 0.90 |
Interventions
Interventions (1)
| Intervention | Type | Mapped drug | Match |
|---|---|---|---|
| Dinutuximab | Drug | Dinutuximab | ALIAS |
Design
Arms and outcomes
Arms (1)
- label
- Dinutuximab administered for 5 cycles
- description
- High-risk neuroblastoma patient treated with Unituxin as standard of care
- interventionNames
- Drug: Dinutuximab
Primary outcomes (1)
- measure
- To Determine the Incidence of Human Anti-chimeric Antibody (HACA) in High-risk Neuroblastoma Patients Treated With Unituxin Combination Therapy.
- timeFrame
- Approximately 6 months
- description
- Seven blood samples were collected at the following time points for the evaluation of HACA levels: * Course 1- Prior to the first Unituxin infusion * Course 2- Prior to the first Unituxin infusion * Course 3- Prior to the first Unituxin infusion * Course 4- Prior to the first Unituxin infusion * Course 5- Prior to the first Unituxin infusion * Course 6- Prior to the first dose of 13-cis-retinoic acid (RA) * Study termination (approximately 2 weeks following the final 13-cis-retinoic acid dose)
Secondary outcomes (3)
- measure
Eligibility
Eligibility (as posted)
- Sex
- All
- Minimum age
- 1 Year
- Maximum age
- 18 Years
Show eligibility criteria text
Inclusion Criteria: * Patient had been diagnosed with high-risk neuroblastoma. * Patient had been prescribed Unituxin and plans to start Unituxin therapy within 30 days of study entry. * Patient started Unituxin therapy no later than 200 days after Autologous Stem Cell Transplantation (ASCT). * Written informed consent / assent was obtained in accordance with institutional and International Conference on Harmonisation (ICH) guidelines. Exclusion Criteria: * Patient had received prior anti-disialoganglioside (anti-GD2) antibody therapy. * Patient had participated in an investigational clinical trial with tumor therapeutic intent within 30 days of informed consent. * Patient underwent Autologous Stem Cell Transplantation (ASCT) more than 200 days prior to receiving Unituxin therapy.
References
Publications (0)
Data not yet available
No reference posted for this study.