Naxitamab Added to Induction for Newly Diagnosed High-Risk Neuroblastoma
ConditionNeuroblastoma
Trial statusRecruiting
Trial phasePhase 2
Trial typeInterventional
Biological sexAll
Age12-21
SponsorGiselle Sholler
About this trial
This is a prospective, multicenter clinical trial in subjects with newly diagnosed high-risk neuroblastoma to evaluate the efficacy and safety of administering naxitamab with standard induction therapy. The initial chemotherapy will include 5 cycles of multi-agent chemotherapy. Naxitamab will be added to all 5 Induction cycles. We hypothesize that the addition of anti-GD2 therapy to induction chemotherapy will result in improved end of induction responses and improved survival.
Eligibility criteria
Qualifiers
MYCN amplification (> 4-fold increase in MYCN signals as compared to reference signals), regardless of additional biologic features; OR
365 days to ≥ 547 days of age without MYCN amplification, but unfavorable biologic features such as unfavorable histology (INPC) or diploid tumor (DNA index=1) or the presence of any segmental chromosome aberration (SCA) (somatic copy number loss at 1p, 3p, 4p, or 11q or somatic copy number gain at 1q, 2p, or 17q); OR
Age > 547 days of age regardless of biologic features
MYCN amplification (> 4-fold increase in MYCN signals as compared to reference signals); OR
Disqualifiers
Subjects who are less than 1 year of age
Subjects who are 12-18 months of age with INRGSS Stage M and all stage L2 subjects with favorable biologic features (i.e., nonamplified MYCN, favorable pathology, and DNA index > 1) are not eligible.
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.
Treatment with immunosuppressive treatment (topical, inhaled and short-term emergency steroids excluded) within 4 weeks prior to enrollment
Trial design
Treatments tested in this trial
- Naxitamab
Treatment groups
93 Participants
are divided into 1 treatment groupSponsors and collaborators
Giselle Sholler
Lead sponsor
Milton S. Hershey Medical Center
Sponsor institution
Y-mAbs Therapeutics
Collaborator
Source ClinicalTrials.gov