Clinical trial · Interventional
N10: A Study of Reduced Chemotherapy and Monoclonal Antibody (mAb)-Based Therapy in Children With Neuroblastoma
N10: Reduced Therapy for High-Risk Neuroblastoma
NCT06528496CI-TRIAL-00124318recruitingPhase 2ClinicalTrials.gov clinicaltrialsProvenance
- Source
- ClinicalTrials.gov
- Retrieved
- Sep 8, 2026
- Layer
- normalized (units and labels harmonized; values unchanged)
- Run
- ING-CLINICALTRIALS-20260908-000001
Summary
Brief summary (as posted)
The purpose of this study is to find out whether N10 chemotherapy is a safe and effective treatment for children with high-risk neuroblastoma.
Conditions
Conditions (3)
Free-text conditions as registered, with the CancerIndex entity they were reconciled to and the match type.
| Condition (as posted) | Mapped entity | Match | Confidence |
|---|---|---|---|
| Childhood Neuroblastoma | Childhood Neuroblastoma | ONTOLOGY_EXACT | 0.98 |
| High-risk Neuroblastoma | High Risk Neuroblastoma | ONTOLOGY_EXACT | 0.98 |
| Neuroblastoma | Neuroblastoma | ONTOLOGY_EXACT | 0.90 |
Interventions
Interventions (12)
| Intervention | Type | Mapped drug | Match |
|---|---|---|---|
| Carboplatin | Drug | Carboplatin | ALIAS |
| Cytoxan | Drug | Cyclophosphamide | ALIAS |
| DANYELZA | Biological | — | UNRESOLVED |
| Doxorubicin | Drug | Doxorubicin | ALIAS |
| Etoposide | Drug | Etoposide | ALIAS |
| Ifosfamide | Drug | Ifosfamide | ALIAS |
| Irinotecan | Drug | Irinotecan | ALIAS |
| Radiation Therapy | Radiation | — | UNRESOLVED |
| Sargramostim | Biological |
Design
Arms and outcomes
Arms (1)
- type
- EXPERIMENTAL
- label
- Participants with Neuroblastoma
- description
- Participants will receive 4 cycles of induction chemotherapy followed by a response-based intervention.
- interventionNames
- Biological: DANYELZA
- Biological: Sargramostim
- Drug: Cytoxan
- Drug: Topotecan
- Drug: Vincristine
- Drug: Doxorubicin
- Drug: Ifosfamide
- Drug: Etoposide
- Drug: Carboplatin
- Drug: Irinotecan
- Drug: Temozolomide
- Radiation: Radiation Therapy
Primary outcomes (1)
- measure
- Evaluate participant response
- timeFrame
- After 2 cycles of mAb-based therapy (each cycle is 21 days)
- description
- To assess the early Complete Response/CR rate in newly-diagnosed HR-NB patients.
Eligibility
Eligibility (as posted)
- Sex
- All
- Minimum age
- 18 Months
- Maximum age
- 19 Years
Show eligibility criteria text
Inclusion Criteria: * Diagnosis of NB as defined by histopathology, BM metastases plus high urine catecholamine levels, or positivity in MIBG scan. * HR-NB, defined as MYCN-amplified stage L2/M/MS at any age and stage M in patients \>18 months old. * No more than one prior cycle of HR-NB chemotherapy * Age \<19 years. * Signed informed consent indicating awareness of the investigational nature of this treatment. Exclusion Criteria: * Severe dysfunction of major organs, i.e., renal, cardiac, hepatic, neurologic, pulmonary, hematologic, or gastrointestinal toxicity \>/= to grade 3 °Organ dysfunction due to direct effects of primary tumor or metastatic disease, or due to paraneoplastic syndromes associated with neuroblastoma, will not be considered in exclusion criteria. Similarly, complications of interventions to control above direct effects (e.g., steroid- induced hyperglycemia or hypertension) will also not be considered in exclusion criteria * Inability to comply with protocol requirements * Pregnancy
References
Publications (0)
Data not yet available
No reference posted for this study.