Status:
RECRUITING
Naxitamab for High-Risk Neuroblastoma Patients With Primary Refractory Disease or Incomplete Response to Salvage Treatment in Bone and/or Bone Marrow
Lead Sponsor:
Y-mAbs Therapeutics
Conditions:
Neuroblastoma
Eligibility:
All Genders
1+ years
Phase:
PHASE2
Brief 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...
Detailed Description
Each patient will receive treatment for up to 101 weeks following the first Naxitamab administration. After the end of trial visit, each patient will enter a long-term follow-up where they will be mon...
Eligibility Criteria
Inclusion
- Diagnosis of neuroblastoma as defined per International Neuroblastoma Response Criteria
- 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.
- Life expectancy ≥ 6 months
Exclusion
- Any systemic anti-cancer therapy, including chemotherapy or immunotherapy, within 3 weeks before 1st dose of GM-CSF
- Evaluable neuroblastoma outside bone and bone marrow
- Existing major organ dysfunction \> Grade 2, with the exception of hearing loss, hematological status, kidney and liver function
- Active life-threatening infection
Key Trial Info
Start Date :
April 3 2018
Trial Type :
INTERVENTIONAL
Allocation :
ESTIMATED
End Date :
April 1 2028
Estimated Enrollment :
122 Patients enrolled
Trial Details
Trial ID
NCT03363373
Start Date
April 3 2018
End Date
April 1 2028
Last Update
August 17 2025
Active Locations (26)
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1
University of Florida
Gainesville, Florida, United States, 32611
2
University of Chicago
Chicago, Illinois, United States, 60637
3
Riley Hospital for Children
Indianapolis, Indiana, United States, 46202
4
Memorial Sloan Kettering Cancer Center
New York, New York, United States, 10065