NCT06574698 Adding Of Naxitamb In Induction Therapy For High Risk Neuroblastoma
| NCT ID | NCT06574698 |
| Status | Recruiting |
| Phase | — |
| Sponsor | Guangzhou Women and Children's Medical Center |
| Condition | Neuroblastoma |
| Study Type | OBSERVATIONAL |
| Enrollment | 64 participants |
| Start Date | 2024-05-06 |
| Primary Completion | 2029-12-31 |
Trial Parameters
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Brief Summary
To explore the efficacy of adding anti-GD2 immunotherapy (Naxitamab) at the stage of induction chemotherapy for newly diagnosed high risk neuroblastoma patients. To investigate wether anding Naxitamab in the induction phase will improve the response rate at the end of induction therapy and further improve the overall survival rate.
Eligibility Criteria
Inclusion Criteria: Neuroblastoma patients who meet certain criteria are eligible for enrollment in the following stages of diagnosis: 1. Children with newly diagnosed stage 4 neuroblastoma according to the International Neuroblastoma Staging System (INSS) who meet the following criteria are eligible for enrollment: i. Age \> 18 months (\> 547 days) regardless of biological characteristics; or ii. Age 12-18 months (365-547 days), with one of the following three unfavorable biological characteristics (MYCN amplification, pathological type of poor histopathological prognosis, and/or DNA index = 1); or iii. MYCN amplification (MYCN signal increase \> 4 times compared to reference signal) regardless of age or other biological characteristics. 2. Children with newly diagnosed stage 3 INSS neuroblastoma who meet the following criteria are eligible for enrollment: i. MYCN amplification (MYCN signal increase \> 4 times compared to reference signal) regardless of age or other biological charact