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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 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.

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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

Conditions Studied

Neuroblastoma

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

FieldValue
Enrollment Target 122 participants
Start Date 2018-04-03
Est. Completion 2028-04
Phase Phase 2

Sponsor

Y-mAbs Therapeutics

11 total trials

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Full Details on ClinicalTrials.gov ↗

What the Registry Record Tells You About NCT03363373

The ClinicalTrials.gov registry entry for NCT03363373 describes a study currently listed as recruiting, categorized as Phase 2. The registered enrollment target is 122 participants, a figure that helps gauge the scale of data the investigators plan to collect, below the 238-participant average among 94 other Neuroblastoma trials with a reported enrollment target (49% lower). The listed sponsor is Y-mAbs Therapeutics, which has 11 total studies on file at ClinicalTrials.gov.

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 reports 20 study locations spanning 10 distinct geographic areas - top geographies include 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.

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Data sourced from official public datasets. See our methodology for details. Retrieved and formatted by PlainTrial Editorial

Every figure on PlainTrial is rendered directly from the ClinicalTrials.gov registry, no number is typed in by an editor. This page mirrors this trial's own ClinicalTrials.gov registry record, live from the dataset. See our editorial standards & corrections policy, the methodology behind these numbers, or report a data error.