Naxitamab and Granulocyte-Macrophage Colony Stimulating Factor (GM-CSF) Combined With Isotretinoin for Maintenance Treatment of Patients With High-Risk Neuroblastoma in First Complete Response.

PHASE4Not yet recruitingINTERVENTIONAL
Enrollment

62

Participants

Timeline

Start Date

October 31, 2023

Primary Completion Date

June 15, 2027

Study Completion Date

August 15, 2027

Conditions
Neuroblastoma
Interventions
DRUG

Naxitamab

"Naxitamab + GM-CSF:~Cycles 1-5: Patients will receive naxitamab IV at 3 mg/kg/infusion on Day 1, 3 and 5 and GM-CSF sc at 5 µg/kg/day on Days -4 to 0 and at 10 µg/kg/day on Days 1-5 for 5 cycles.~Isotretinoin:~Cycles 3-8: Patients will receive isotretinoin PO at 160 mg/m2/day divided into two daily doses on Days 15-28 for 6 cycles."

Sponsors
All Listed Sponsors
lead

SciClone Pharmaceuticals

INDUSTRY