Adding Of Naxitamb In Induction Therapy For High Risk Neuroblastoma
NCT ID: NCT06574698
Last Updated: 2024-08-28
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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RECRUITING
64 participants
OBSERVATIONAL
2024-05-06
2032-12-31
Brief Summary
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Detailed Description
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Conditions
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Study Design
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COHORT
PROSPECTIVE
Study Groups
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High risk Neuroblastoma
High risk Neuroblastoma
Addition of anti-GD2 immunotherapy (Naxitamab) at the stage of induction chemotherapy
Addition of anti-GD2 immunotherapy (Naxitamab) at the stage of induction chemotherapy
Interventions
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Addition of anti-GD2 immunotherapy (Naxitamab) at the stage of induction chemotherapy
Addition of anti-GD2 immunotherapy (Naxitamab) at the stage of induction chemotherapy
Eligibility Criteria
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Inclusion Criteria
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 characteristics; or ii. Age \> 18 months (\> 547 days), with pathological type of poor histopathological prognosis regardless of MYCN status.
3. Children with newly diagnosed stage 2A/2B INSS neuroblastoma with MYCN amplification (MYCN signal increase \> 4 times compared to reference signal) regardless of age or other biological characteristics. The subject must be aged ≤ 21 years at the time of initial diagnosis, and must be aged \> 12 months at the time of enrollment.
Exclusion Criteria
Subjects who have received immunosuppressive treatment (excluding local steroids) within the last 4 weeks prior to enrollment. Subjects who are currently receiving any investigational drug.
1 Year
21 Years
ALL
No
Sponsors
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Guangzhou Women and Children's Medical Center
OTHER
Responsible Party
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Tianyou Yang
Chief Surgeon of Pediatric surgical oncology
Locations
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Guangzhou Women And Children's Medical Center
Guanzhou, Guangdong, China
Countries
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Central Contacts
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Facility Contacts
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Other Identifiers
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neuroblastoma 2024
Identifier Type: -
Identifier Source: org_study_id
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