IT With or Without Naxitamab and GM CSF in Patients With High-Risk Neuroblastoma
Last updated on July 2021Recruitment
- Recruitment Status
- Not yet recruiting
- Estimated Enrollment
- Same as current
Summary
- Conditions
- Neuroblastoma Recurrent
- Type
- Interventional
- Phase
- Phase 3
- Design
- Allocation: RandomizedIntervention Model: Parallel AssignmentIntervention Model Description: Randomization is handled via IWRSMasking: Single (Outcomes Assessor)Masking Description: Randomization is handled via IWRSPrimary Purpose: Treatment
Participation Requirements
- Age
- Between 12 years and 125 years
- Gender
- Both males and females
Description
This is an open label, randomized, controlled, multicenter phase 3 trial, in patients ? 12 months of age with high-risk NB with primary refractory disease or in first relapse. Patients will be randomized 2:1 to receive either IT + naxitamab + GM-CSF or IT alone. Patients randomized to treatment with...
This is an open label, randomized, controlled, multicenter phase 3 trial, in patients ? 12 months of age with high-risk NB with primary refractory disease or in first relapse. Patients will be randomized 2:1 to receive either IT + naxitamab + GM-CSF or IT alone. Patients randomized to treatment with IT alone who either develop progressive disease or do not achieve overall response at or during the initial 4 cycles or who discontinue IT treatment due to toxicity, will be offered treatment with naxitamab + GM-CSF; naxitamab treatment can be administered with IT (treatment group C) or without IT (Treatment group D), as applicable. The Follow-Up period ends 2 years after randomization.
Tracking Information
- NCT #
- NCT04560166
- Collaborators
- Not Provided
- Investigators
- Not Provided
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