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NCT05489887 · ClinicalTrials.gov registry record · Phase 2
Naxitamab Added to Induction for Newly Diagnosed High-Risk Neuroblastoma
A Phase 2 study of Neuroblastoma, sponsored by Giselle Sholler.
- Recruiting
- Registry status
- Phase 2
- Development phase
- 93
- Enrollment target
- 20
- Study locations
NCT05489887: Recruiting Phase 2 study of Neuroblastoma, sponsored by Giselle Sholler.
NCT05489887 is a Phase 2 study of Neuroblastoma that is actively recruiting participants, run by Giselle Sholler. The registered enrollment target is 93 participants, below the 238-participant average among 94 other Neuroblastoma trials with a reported enrollment target (61% lower). The trial reports 20 study locations across 16 states. According to ClinicalTrials.gov, the official US trial registry.
The verdict
NCT05489887, a Phase 2 study of Neuroblastoma, is actively recruiting participants, sponsored by Giselle Sholler.
- RECRUITING
- Registry status
- Phase 2
- Development phase
- 93 participants
- Enrollment target
- 20
- Study locations
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.
Primary Outcome
Measured by the presence of radiologically assessable disease by cross-sectional computed tomography (CT) or Magnetic resonance imaging (MRI) imaging and/or by metaiodobenzylguanidine (MIBG) or positron emission tomography (PET) scans and bone marrow (BM) response for subjects with newly-diagnosed high-risk neuroblastoma according to the 1993 International Neuroblastoma Response Criteria (INRC) and compare to relevant historical controls.
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 |
What NCT05489887 shows while recruiting
NCT05489887 is an interventional study that assigns participants to a tested intervention. The registry caps enrollment at 93 participants, a relatively small participant target, below the 238-participant average among 94 other Neuroblastoma trials with a reported enrollment target (61% lower).
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.
NCT05489887 names 20 study sites across 16 states, led by Florida, California, North Carolina.
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.
What interventions are being tested in trial NCT05489887?
The interventions under investigation include: Naxitamab (DRUG).
Who is sponsoring clinical trial NCT05489887?
This trial is sponsored by Giselle Sholler, which has 20 total clinical trials registered on ClinicalTrials.gov.
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.
Learn More About Clinical Trials
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Matched on the same primary condition, ranked to surface studies in the same phase first, then by recruiting status, no relevance scoring or editorial curation.
Where NCT05489887's enrollment target sits among peer trials
93 32nd of 94 higher than 62 of 94 other Neuroblastoma trials
participants (enrollment target), bucketed by value
Each bar is a band; taller bars hold more other Neuroblastoma trials. The dashed line + filled bar mark this entry. Hover or tap any bar for its full count and share, and where it sits relative to this entry.
Source ClinicalTrials.gov registry export · 2026-08-08
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