drugset / Trial / NCT04909515
Naxitamab and Granulocyte-Macrophage Colony Stimulating Factor (GMCSF) and Isotretinoin for Consolidation of Patients With High-Risk Neuroblastoma in First Remission.
NaSingle-groupOpen-labelTreatment
Summary
This is a single-arm, uncontrolled, international, multi-center, clinical,phase 2 trial, in patients ≥ 12 months of age with high-risk neuroblastoma in first remission. 120 patients will be enrolled to receive naxitamab + GM-CSF in combination with isotretinoin.
Timeline
- Start
- 2021-12-02
- Primary completion
- 2026-06
- Completion
- 2027-04
Drugs
| Evaluation | Drug | Modality | Dose | Route |
|---|---|---|---|---|
| Subject | Isotretinoin | Other / unclassified | 160 mg/m2 | — |
| Subject | Naxitamab | Monoclonal antibody | 3 mg/kg | — |
| Subject | sargramostim | Protein / enzyme biologic | 250 ug/m2 | — |
| Subject | sargramostim | Protein / enzyme biologic | 500 ug/m2 | — |