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

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

Conditions

Neuroblastoma

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Study Overview

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Study Details

Study overview

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

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

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

Condition
Neuroblastoma
Intervention / Treatment

-

Contacts and Locations

Gainesville

University of Florida, Gainesville, Florida, United States, 32611

Chicago

University of Chicago, Chicago, Illinois, United States, 60637

Indianapolis

Riley Hospital for Children, Indianapolis, Indiana, United States, 46202

New York

Memorial Sloan Kettering Cancer Center, New York, New York, United States, 10065

Columbus

Nationwide Children's Hospital, Columbus, Ohio, United States, 43205

Houston

M.D. Anderson Cancer Center, Houston, Texas, United States, 77030

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.

For general information about clinical research, read Learn About Studies.

Eligibility 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
  • * 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

Ages Eligible for Study

1 Year to

Sexes Eligible for Study

ALL

Accepts Healthy Volunteers

No

Collaborators and Investigators

Y-mAbs Therapeutics,

Study Record Dates

2028-04