This clinical trial will evaluate the safety of chemoimmunotherapy with Naxitamab and COG-type induction chemotherapy in newly-diagnosed patients with high-risk neuroblastoma. We aim to recruit 10 patients over the next 2 years.
Age - 12 months to 21 years at protocol enrollment
Newly diagnosed high risk neuroblastoma.
BOTH stage M (INRG - International Neuroblastoma Risk Group) and age ≥547 days.
Patients ≥ 547 days of age who were initially diagnosed with INRG L1 or L2 disease but progress to Stage M without chemotherapy
Subjects who have had prior systemic therapy except for localized emergency radiation to sites of life-threatening or function-threatening disease and/or no more than 1 cycle of chemotherapy.
This will not restrict the emergency regimen at initial diagnosis.
Patients who are 365-546 days of age with INRG Stage M and MYCN non-amplified NBL, irrespective of additional biologic features.
Patients ≥547 days of age with INRG Stage L2, MYCN non-amplified NBL, regardless of additional biologic features.
Shaare Zedek Medical Center
Lead sponsor
Y-mAbs Therapeutics
Collaborator