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 |
Eligibility & Interventions
Eligibility Fast-Check
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What to Expect as a Participant
This is an observational study. You will not receive an experimental treatment; researchers will collect data based on your existing condition or standard treatment.
This trial targets 64 participants in total. It began in 2024-05-06 with a primary completion date of 2029-12-31.
⚠ This information is for research awareness only. Always consult your physician before joining any clinical trial. Participation is voluntary and you may withdraw at any time.
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 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: 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)
Contact & Investigator
Frequently Asked Questions
Who can join the NCT06574698 clinical trial?
This trial is open to participants of all sexes, aged 1 Year or older, up to 21 Years, studying Neuroblastoma. Full inclusion and exclusion criteria are listed in the Eligibility Criteria section. Always confirm your eligibility with the research team before applying.
Is NCT06574698 currently recruiting?
Yes, NCT06574698 is actively recruiting participants. Contact the research team at feky@gwcmc.org for enrollment information.
Where is the NCT06574698 trial being conducted?
This trial is being conducted at Guanzhou, China.
Who is sponsoring the NCT06574698 clinical trial?
NCT06574698 is sponsored by Guangzhou Women and Children's Medical Center. The trial plans to enroll 64 participants.