Status:
RECRUITING
Adding Of Naxitamb In Induction Therapy For High Risk Neuroblastoma
Lead Sponsor:
Guangzhou Women and Children's Medical Center
Conditions:
Neuroblastoma
GD2 Antibody (Naxitamab)
Eligibility:
All Genders
1-21 years
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...
Eligibility Criteria
Inclusion
- Inclusion Criteria:
- Neuroblastoma patients who meet certain criteria are eligible for enrollment in the following stages of diagnosis:
- 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.
- 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.
- 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:
- Infants less than 1 year old, those aged 12-18 months, INSS stage 4, and all INSS stage 3 patients with favorable biological characteristics (i.e., non-amplified MYCN, good pathological histopathological prognosis, and DNA index \>1) are not eligible.
- 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.
- Any other medical condition that, in the opinion of the investigator, may interfere with the interpretation of results or affect the subject's ability to provide informed consent, the legal guardian's ability to provide informed consent, and the subject's cooperation and participation in the study, including but not limited to malabsorption syndrome, mental illness, or substance abuse. Subjects with significant comorbidities (any serious medical condition unrelated to cancer or its treatment that is not covered by the detailed exclusion criteria and is expected to interfere with the investigation drug(s) action or significantly increase the severity of the trial treatment toxicity)
Exclusion
Key Trial Info
Start Date :
May 6 2024
Trial Type :
OBSERVATIONAL
Allocation :
ESTIMATED
End Date :
December 31 2032
Estimated Enrollment :
64 Patients enrolled
Trial Details
Trial ID
NCT06574698
Start Date
May 6 2024
End Date
December 31 2032
Last Update
August 28 2024
Active Locations (1)
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1
Guangzhou Women And Children's Medical Center
Guanzhou, Guangdong, China, 510000