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NCT03363373 · ClinicalTrials.gov registry record · Phase 2
Naxitamab for High-Risk Neuroblastoma Patients With Primary Refractory Disease or Incomplete Response to Salvage Treatment in Bone and/or Bone Marrow
A Phase 2 study of Neuroblastoma, sponsored by Y-mAbs Therapeutics.
- Recruiting
- Registry status
- Phase 2
- Development phase
- 122
- Enrollment target
- 20
- Study locations
NCT03363373: Recruiting Phase 2 study of Neuroblastoma, sponsored by Y-mAbs Therapeutics.
NCT03363373 is a Phase 2 study of Neuroblastoma that is actively recruiting participants, run by Y-mAbs Therapeutics. The registered enrollment target is 122 participants, below the 238-participant average among 94 other Neuroblastoma trials with a reported enrollment target (49% lower). The trial reports 20 study locations across 10 states. According to ClinicalTrials.gov, the official US trial registry.
The verdict
NCT03363373, a Phase 2 study of Neuroblastoma, is actively recruiting participants, sponsored by Y-mAbs Therapeutics.
- RECRUITING
- Registry status
- Phase 2
- Development phase
- 122 participants
- Enrollment target
- 20
- Study locations
Study Summary
Children and adults diagnosed with high-risk neuroblastoma patients with primary refractory disease or incomplete response to salvage treatment in bone and/or bone marrow will be treated for up to 101 weeks with naxitamab and granulocyte-macrophage colony stimulating factor (GM-CSF). Patients will be followed for up to five years after first dose. Naxitamab, also known as hu3F8 is a humanised monoclonal antibody targeting GD2
Primary Outcome
Overall objective response rate (ORR) during the Naxitamab treatment period that will be centrally assessed according to the International Neuroblastoma Response Criteria (INRC) modified with 123I-MIBG criteria and following the use of 18F FDG-PET for MIBG non-avid lesions.
Conditions Studied
Interventions
- BIOLOGICAL GM-CSF + Naxitamab
Study Locations (20)
Other
- The Hospital for Sick Children - Toronto
- Rigshospitalet - Copenhagen
- University Medical Center Hamburg-Eppendorf - Hamburg
- Johannes Gutenberg-Universität - Mainz
- University Hospital Regensburg - Regensburg
- Hong Kong Children's Hospital - Hong Kong
- Queen Mary Hospital - Hong Kong
- Tata Memorial Centre - Mumbai
- Ospedale Pediatrico Bambino Gesù - Rome
- Hospital Sant Joan de Déu - Barcelona
- Hospital Infantil Universitario Niño Jesús - Madrid
Florida
- University of Florida - Gainesville
Illinois
- University of Chicago - Chicago
Indiana
- Riley Hospital for Children - Indianapolis
New York
- Memorial Sloan Kettering Cancer Center - New York
Ohio
- Nationwide Children's Hospital - Columbus
Texas
- M.D. Anderson Cancer Center - Houston
Marseille
- Hopital pour enfants de la Timone - Marseille
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 122 participants |
| Start Date | 2018-04-03 |
| Est. Completion | 2028-04 |
| Phase | Phase 2 |
What NCT03363373 shows while recruiting
NCT03363373 is an interventional study that assigns participants to a tested intervention. The registered 122 participants enrollment target is mid-sized for trials with a published cap, below the 238-participant average among 94 other Neuroblastoma trials with a reported enrollment target (49% lower).
The record links to 1 condition, with Neuroblastoma appearing as the primary indexed condition, and to 1 intervention - of which GM-CSF + Naxitamab is the first listed.
NCT03363373 names 20 study sites across 10 states, led by Other, Florida, Illinois.
Frequently Asked Questions
What is clinical trial NCT03363373 about?
NCT03363373 is a clinical study titled "Naxitamab for High-Risk Neuroblastoma Patients With Primary Refractory Disease or Incomplete Response to Salvage Treatment in Bone and/or Bone Marrow". Children and adults diagnosed with high-risk neuroblastoma patients with primary refractory disease or incomplete response to salvage treatment in bone and/or bone marrow will be treated for up to 101 weeks with naxitamab and granulocyte-macrophage colony stimulating factor (GM-CSF). Patients will b...
What is the current status of trial NCT03363373?
This trial is currently recruiting. It is a Phase 2 study. The enrollment target is 122 participants. The study started on 2018-04-03. Estimated completion is 2028-04.
What conditions does trial NCT03363373 study?
This clinical trial studies the following conditions: Neuroblastoma.
What interventions are being tested in trial NCT03363373?
The interventions under investigation include: GM-CSF + Naxitamab (BIOLOGICAL).
Who is sponsoring clinical trial NCT03363373?
This trial is sponsored by Y-mAbs Therapeutics, which has 11 total clinical trials registered on ClinicalTrials.gov.
Where is trial NCT03363373 being conducted?
This trial has 20 study locations across Florida, Illinois, Indiana, New York, Ohio. Contact the study sites directly through ClinicalTrials.gov for enrollment availability.
Learn More About Clinical Trials
Similar trials for Neuroblastoma
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 NCT03363373's enrollment target sits among peer trials
122 25th of 94 higher than 69 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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