Trials / Withdrawn
WithdrawnNCT04909515
Naxitamab and Granulocyte-Macrophage Colony Stimulating Factor (GMCSF) and Isotretinoin for Consolidation of Patients With High-Risk Neuroblastoma in First Remission.
Naxitamab and Granulocyte-Macrophage Colony Stimulating Factor (GMCSF) and Isotretinoin for Consolidation of Patients With High-Risk Neuroblastoma in First Remission. An International, Open-Label,Uncontrolled, Single-Arm, Multicenter, Phase 2 Trial
- Status
- Withdrawn
- Phase
- Phase 2
- Study type
- Interventional
- Enrollment
- 0 (actual)
- Sponsor
- Y-mAbs Therapeutics · Industry
- Sex
- All
- Age
- 1 Year
- Healthy volunteers
- Not accepted
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.
Conditions
Interventions
| Type | Name | Description |
|---|---|---|
| DRUG | Naxitamab | 3.0 mg/kg/day = 9.0 mg/kg/cycle |
| DRUG | GM-CSF | 250 - 500 microgram/m2/day |
| DRUG | Isotretinoin | 160 mg/m2/day |
Timeline
- Start date
- 2021-12-02
- Primary completion
- 2026-06-01
- Completion
- 2027-04-01
- First posted
- 2021-06-01
- Last updated
- 2022-09-01
Locations
9 sites across 4 countries: Hong Kong, Russia, Singapore, South Korea
Regulatory
- FDA-regulated drug study
Source: ClinicalTrials.gov record NCT04909515. Inclusion in this directory is not an endorsement.