RECRUITING

Naxitamab for High-Risk Neuroblastoma Patients With Primary Refractory Disease or Incomplete Response to Salvage Treatment in Bone and/or Bone Marrow

Study Overview

This clinical trial focuses on testing the efficacy of different digital interventions to promote re-engagement in cancer-related long-term follow-up care for adolescent and young adult (AYA) survivors of childhood cancer.

Description

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

Official Title

A Pivotal Phase 2 Trial of Antibody Naxitamab (hu3F8) and Granulocyte-Macrophage Colony Stimulating Factor (GM-CSF) in High-Risk Neuroblastoma Patients With Primary Refractory Disease or Incomplete Response to Salvage Treatment in Bone and/or Bone Marrow

Quick Facts

Study Start:2018-04-03
Study Completion:2028-04
Study Type:Not specified
Phase:Not Applicable
Enrollment:Not specified
Status:RECRUITING

Study ID

NCT03363373

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Ages Eligible for Study:1 Year
Sexes Eligible for Study:ALL
Accepts Healthy Volunteers:No
Standard Ages:CHILD, ADULT, OLDER_ADULT
Inclusion CriteriaExclusion Criteria
  1. * Diagnosis of neuroblastoma as defined per International Neuroblastoma Response Criteria
  2. * High-risk neuroblastoma patients with either primary refractory disease or incomplete response to salvage treatment (in both cases including stable disease, minor response and partial response) evaluable in bone and/or bone marrow.
  3. * Life expectancy ≥ 6 months
  1. * Any systemic anti-cancer therapy, including chemotherapy or immunotherapy, within 3 weeks before 1st dose of GM-CSF
  2. * Evaluable neuroblastoma outside bone and bone marrow
  3. * Existing major organ dysfunction \> Grade 2, with the exception of hearing loss, hematological status, kidney and liver function
  4. * Active life-threatening infection

Contacts and Locations

Study Contact

Joris Wilms
CONTACT
+4570261414
clinicaltrials@ymabs.com

Study Locations (Sites)

University of Florida
Gainesville, Florida, 32611
United States
University of Chicago
Chicago, Illinois, 60637
United States
Riley Hospital for Children
Indianapolis, Indiana, 46202
United States
Memorial Sloan Kettering Cancer Center
New York, New York, 10065
United States
Nationwide Children's Hospital
Columbus, Ohio, 43205
United States
M.D. Anderson Cancer Center
Houston, Texas, 77030
United States

Collaborators and Investigators

Sponsor: Y-mAbs Therapeutics

Study Record Dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Registration Dates

Study Start Date2018-04-03
Study Completion Date2028-04

Study Record Updates

Study Start Date2018-04-03
Study Completion Date2028-04

Terms related to this study

Keywords Provided by Researchers

  • Antibody, Neuroblastoma, Pediatric, Adult

Additional Relevant MeSH Terms

  • Neuroblastoma