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Naxitamab and Granulocyte-Macrophage Colony Stimulating Factor (GMCSF) and Isotretinoin for Consolidation of Patients With High-Risk Neuroblastoma in First Remission.

NCT04909515 · Status: WITHDRAWN · Phase: PHASE2 · Type: INTERVENTIONAL

Last updated 2022-09-01

No results posted yet for this study

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

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

Sponsors & Collaborators

  • Y-mAbs Therapeutics

    lead INDUSTRY

Study Design

Allocation
NA
Purpose
TREATMENT
Masking
NONE
Model
SINGLE_GROUP

Eligibility

Min Age
1 Year
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2021-12-02
Primary Completion
2026-06-30
Completion
2027-04-30
FDA Drug
Yes

Countries

  • Hong Kong
  • Russia
  • Singapore
  • South Korea

Study Locations

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Entities

Drugs
Diseases

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT04909515 on ClinicalTrials.gov