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Naxitamab Added to Induction for Newly Diagnosed High-Risk Neuroblastoma
NCT05489887 · View on ClinicalTrials.gov ↗
Study Summary
This is a prospective, multicenter clinical trial in subjects with newly diagnosed high-risk neuroblastoma to evaluate the efficacy and safety of administering naxitamab with standard induction therapy. The initial chemotherapy will include 5 cycles of multi-agent chemotherapy. Naxitamab will be added to all 5 Induction cycles. We hypothesize that the addition of anti-GD2 therapy to induction chemotherapy will result in improved end of induction responses and improved survival.
Conditions Studied
Interventions
- DRUG Naxitamab
Study Locations (20)
Florida
- University of Florida — Gainesville
- Nicklaus Children's Hospital — Miami
- Arnold Palmer Hospital for Children — Orlando
California
- UCSF Benioff Children's Hospital Oakland — Oakland
- Rady Children's Hospital — San Diego
North Carolina
- Levine Children's Hospital — Charlotte
- Wake Forest University Health Sciences — Winston-Salem
Alabama
- University of Alabama/Children's of Alabama — Birmingham
Arkansas
- Arkansas Children's Hospital — Little Rock
Connecticut
- Connecticut Children's Hospital — Hartford
Georgia
- Augusta University Health — Augusta
Hawaii
- Kapiolani Medical Center for Women and Children — Honolulu
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 93 participants |
| Start Date | 2022-09-14 |
| Est. Completion | 2036-09 |
| Phase | Phase 2 |
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Full Details on ClinicalTrials.gov ↗What the Registry Record Tells You About NCT05489887
The ClinicalTrials.gov registry entry for NCT05489887 describes a study currently listed as recruiting. It is categorized as Phase 2, which is the standard way researchers label where a study sits along the investigational pathway from early safety work through later efficacy and post-marketing evaluation. The registered enrollment target is 93 participants, a figure that helps gauge the scale of data the investigators plan to collect. The listed sponsor is Giselle Sholler, which has 65 total studies on file at ClinicalTrials.gov, and sponsors are the parties responsible for study design, oversight, and regulatory filings.
The record links to 1 condition, with Neuroblastoma appearing as the primary indexed condition, and to 1 intervention — of which Naxitamab is the first listed. Interventions can include drugs, devices, procedures, behavioral programs, or observational arms, and each is tracked as a separate registry field so that downstream queries can filter accurately. When a trial lists multiple interventions, it usually reflects a multi-arm design or a comparison protocol rather than a single treatment being tested in isolation. The brief summary published in the registry is the clearest source of protocol intent and should be read before drawing conclusions from any sidebar tags.
Geographic footprint matters for practical reasons: NCT05489887 reports 20 study locations spanning 16 distinct geographic areas — top geographies include Florida, California, North Carolina. A larger site network tends to correlate with broader recruitment capacity, but it does not imply anything about study quality, and site-level enrollment status can diverge from the overall registry status shown above. Every data point on this page comes from the public ClinicalTrials.gov dataset and is reproduced here for reference only; it is not a medical recommendation, an endorsement of the sponsor, or an invitation to enroll. Verify current status, eligibility criteria, and contact details directly at ClinicalTrials.gov, and discuss any participation decision with your own healthcare provider.
Frequently Asked Questions
What is clinical trial NCT05489887 about?
NCT05489887 is a clinical study titled "Naxitamab Added to Induction for Newly Diagnosed High-Risk Neuroblastoma". This is a prospective, multicenter clinical trial in subjects with newly diagnosed high-risk neuroblastoma to evaluate the efficacy and safety of administering naxitamab with standard induction therapy. The initial chemotherapy will include 5 cycles of multi-agent chemotherapy. Naxitamab will be add...
What is the current status of trial NCT05489887?
This trial is currently recruiting. It is a Phase 2 study. The enrollment target is 93 participants. The study started on 2022-09-14. Estimated completion is 2036-09.
What conditions does trial NCT05489887 study?
This clinical trial studies the following conditions: Neuroblastoma. These conditions were identified from the trial registry and reflect the primary focus areas of the research.
What interventions are being tested in trial NCT05489887?
The interventions under investigation include: Naxitamab (DRUG). Each intervention is being evaluated for safety and efficacy as part of this clinical study.
Who is sponsoring clinical trial NCT05489887?
This trial is sponsored by Giselle Sholler, which has 65 total clinical trials registered on ClinicalTrials.gov. The sponsor is responsible for the study's design, funding, and regulatory compliance.
Where is trial NCT05489887 being conducted?
This trial has 20 study locations across Alabama, Arkansas, California, Connecticut, Florida. Contact the study sites directly through ClinicalTrials.gov for enrollment availability.
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