Adding Naxitamab to chemotherapy for high-risk neuroblastoma
Adding Of Naxitamb In Induction Therapy For High Risk Neuroblastoma: A Prospective, Single-Arm Clinical Study
This study is testing if adding a new treatment called Naxitamab to chemotherapy can help children with high-risk neuroblastoma respond better to their initial treatment and live longer.
Quick facts
| Study type | Observational |
|---|---|
| Enrollment | 64 (estimated) |
| Ages | 1 Year to 21 Years |
| Sex | All |
| Sponsor | Guangzhou Women and Children's Medical Center Academic / other |
| Drugs / interventions | Naxitamab, chemotherapy, immunotherapy |
| Locations | 1 site (Guanzhou, Guangdong) |
| Trial ID | NCT06574698 on ClinicalTrials.gov |
What this trial studies
This study explores the effectiveness of incorporating anti-GD2 immunotherapy, Naxitamab, during the induction phase of chemotherapy for children with newly diagnosed high-risk neuroblastoma. The goal is to determine if this addition can enhance the response rate at the end of induction therapy and improve overall survival rates. The study focuses on patients with specific biological characteristics that indicate a higher risk of poor outcomes. It is observational in nature, aiming to gather data on the treatment's impact.
Who should consider this trial
Good fit: Ideal candidates include children over 18 months with stage 4 neuroblastoma or those aged 12-18 months with specific unfavorable biological characteristics.
Not a fit: Patients with low-risk neuroblastoma or those who do not meet the specified age and biological criteria may not benefit from this study.
Why it matters
Potential benefit: If successful, this approach could significantly improve treatment outcomes and survival rates for children with high-risk neuroblastoma.
How similar studies have performed: Other studies have shown promise with anti-GD2 therapies in neuroblastoma, suggesting potential for success with this approach.
Eligibility criteria
Show full inclusion / exclusion 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)
Where this trial is running
Guanzhou, Guangdong
- Guangzhou Women And Children's Medical Center — Guanzhou, Guangdong, China (Recruiting)
Study contacts
- Study coordinator: Wenyue Si, Bachelor
- Email: feky@gwcmc.org
- Phone: +86-(020)-38367270
How to participate
- Review the eligibility criteria above with your treating physician.
- Visit the official trial page on ClinicalTrials.gov for the most current contact information and recruitment status.
- Contact the listed study coordinator or principal investigator to request pre-screening. Pre-screening is free and never obligates you to enroll.