Trial Radar
Sign in

NCT lookup

Pull any trial record directly from ClinicalTrials.gov.

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

NCT03363373

Active Not RecruitingPhase 2

Sponsor: Y-mAbs Therapeutics

Conditions: Neuroblastoma

Interventions: GM-CSF + Naxitamab

Countries: United States, Canada, Denmark, Germany, Hong Kong, India, Italy, Spain

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

Eligibility overview

Sex: ALL

Age: 1 Year to —

Healthy volunteers: No

Study type: INTERVENTIONAL

Eligibility criteria
Inclusion Criteria:

* 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 Criteria:

* 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
Locations (20)
  • Indianapolis, Indiana, United States
  • New York, New York, United States
  • Toronto, Canada
  • Copenhagen, Denmark
  • Hamburg, Germany
  • Mainz, Germany
  • Regensburg, Germany
  • Hong Kong, Hong Kong
  • Hong Kong, Hong Kong
  • Mumbai, India
  • Genoa, Genoa, Italy
  • Milan, Milan, Italy
  • Rome, Italy
  • Barcelona, Spain
  • Madrid, Spain
  • Seville, Spain
  • Valencia, Spain
  • Glasgow, United Kingdom
  • Leeds, United Kingdom
  • Southampton, United Kingdom