Naxitamab Added to Induction for Newly Diagnosed High-Risk Neuroblastoma (NCT05489887)

Check every box below. If you can check all of them, you may meet the study's basic screening requirements (final eligibility is confirmed by the site team).

1. Diagnosis: Subjects must have a diagnosis of neuroblastoma or ganglioneuroblastoma (nodular or intermixed) verified by histology or demonstration of clumps of tumor cells in bone marrow with elevated urinary catecholamine metabolites. Subjects with the following disease stages at diagnosis are eligible, if they meet the other specified criteria:
2. Subjects with newly diagnosed neuroblastoma with INRGSS Stage M disease with either of the following features:
3. MYCN amplification (\> 4-fold increase in MYCN signals as compared to reference signals), regardless of additional biologic features; OR
4. 365 days to ≥ 547 days of age without MYCN amplification, but unfavorable biologic features such as unfavorable histology (INPC) or diploid tumor (DNA index=1) or the presence of any segmental chromosome aberration (SCA) (somatic copy number loss at 1p, 3p, 4p, or 11q or somatic copy number gain at 1q, 2p, or 17q); OR
5. Age \> 547 days of age regardless of biologic features Subjects with newly diagnosed neuroblastoma with INRGSS Stage MS disease with either of the following:
6. MYCN amplification (\> 4-fold increase in MYCN signals as compared to reference signals); OR
7. 365 days to ≥ 547 days (18 months) of age without MYCN amplification, but unfavorable biologic features such as unfavorable histology (INPC) or diploid tumor (DNA index=1) or SCA as above Subjects with newly diagnosed neuroblastoma INRGSS Stage L2 disease with either of the following:
8. MYCN amplification (\> 4-fold increase in MYCN signals as compared to reference signals); OR
9. 18 months to \<5 years of age without MYCN amplification, but with unfavorable histology (INPC); OR
10. ≥5 years of age without MYCN amplification, but with undifferentiated or poorly differentiated INPC Subjects with newly diagnosed neuroblastoma INRGSS Stage L1 disease that is incompletely resected with MYCN amplification. Subjects \> 547 days of age initially diagnosed with INRGSS Stage L1, L2 or MS disease who progressed to Stage M without prior chemotherapy may enroll within 4 weeks of progression to Stage M. Subjects ≥ 365 days of age initially diagnosed with MYCN amplified INRGSS Stage L1 disease who progress to Stage M without systemic therapy may enroll within 4 weeks of progression to Stage M.
11. Subjects must be age ≤ 21 years at initial diagnosis.
12. Subjects must be \>12 months of age at enrollment.

🔍 Extracted verbatim from the official NIH eligibility criteria. Always confirm with the study coordinator.

📍 All Participating Trial Locations (26 Sites)

• University of Alabama/Children's of Alabama — Birmingham, Alabama
• Arkansas Children's Hospital — Little Rock, Arkansas
• UCSF Benioff Children's Hospital Oakland — Oakland, California
• Rady Children's Hospital — San Diego, California
• Connecticut Children's Hospital — Hartford, Connecticut
• University of Florida — Gainesville, Florida
• Nicklaus Children's Hospital — Miami, Florida
• Arnold Palmer Hospital for Children — Orlando, Florida
• Augusta University Health — Augusta, Georgia
• Kapiolani Medical Center for Women and Children — Honolulu, Hawaii
• Norton Children's Research Institute/Affiliated with University of Louisville School of Medicine — Louisville, Kentucky
• Children's Hospital and Clinics of Minnesota — Minneapolis, Minnesota
• Cardinal Glennon Children's Hospital — St Louis, Missouri
• Levine Children's Hospital — Charlotte, North Carolina
• Duke University — Durham, North Carolina
• Wake Forest University Health Sciences — Winston-Salem, North Carolina
• Randall Children's Hospital — Portland, Oregon
• Penn State Milton S. Hershey Medical Center and Children's Hospital — Hershey, Pennsylvania
• Medical University of South Carolina — Charleston, South Carolina
• Dell Children's Blood and Cancer Center — Austin, Texas
• Virginia Commonwealth University — Richmond, Virginia
• GRAACC Hospital — São Paulo, São Paulo
• UHC Sainte-Justine — Montreal, Quebec
• CHUQ — Québec, Quebec
• CIUSSS de l'Estrie-CHUS — Sherbrooke, Quebec

💰 Cost, Insurance & Patient Rights

• 100% Free Items: The investigational treatment and protocol-required procedures are supplied at zero cost by the sponsor.
• Routine Patient Care: Under federal law (ACA § 2709) and many state statutes, routine care costs are covered during participation.
• Voluntary Participation: You may withdraw at any time without affecting your standard medical care.