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Induction Chemoimmunotherapy for High-Risk Neuroblastoma
NCT06071897Phase 3
Key facts
- Status
- Recruiting
- Start
- Sep 2023
- Primary completion
- Sep 2026
- Countries
- 1
- Sponsor
- Dmitry Rogachev National Medical Research Center of Pediatric Hematology, Oncology and Immunology
- Modality
- Engineered Antibody Formats, Antibody Conjugates, Monoclonal Antibodies
- Drugs
- Dinutuximab beta
- Conditions
- neuroblastomaganglioneuroblastoma (GNB)
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Overview
Phase 3, open-label, single-arm trial of Dinutuximab beta in neuroblastoma and ganglioneuroblastoma (GNB), sponsored by Dmitry Rogachev National Medical Research Center of Pediatric Hematology, Oncology and Immunology. Primary endpoints: Tolerability of the induction chemoimmunotherapy regimen at 3 years and Toxicity of the induction chemoimmunotherapy regimen at 3 years. Started Sep 2023; status: recruiting.
02
Design
1 arm- Study design
- Non-randomizedOpen-labelSingle group
Induction Chemoimmunotherapy
Standard chemotherapy (N5/N6) combined with dinutuximab beta.
03
Who it enrols
Patients aged 18 months to 18 years with verified stage 4 high-risk neuroblastoma or ganglioneuroblastoma, adequate organ function, and no prior intolerance to study drugs.
04
Endpoints
Primary
Tolerability of the induction chemoimmunotherapy regimen
Toxicity of the induction chemoimmunotherapy regimen
Secondary
Overall Response Rate
Overall Survival
Event Free Survival
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