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Keep this study
Lead
United Therapeutics
This was a multi-center, non-randomized, open-label study in patients with high-risk neuroblastoma to assess the immunogenicity, safety and tolerability of Unituxin combination therapy. Patients enrolled in the study were prescribed Unituxin for the treatment of high-risk neuroblastoma.
Age
1–18
Sex
ALL
Healthy volunteers
Not accepted
You may be eligible if
Patient had been diagnosed with high-risk neuroblastoma.
Patient had been prescribed Unituxin and plans to start Unituxin therapy within 30 days of study entry.
Patient started Unituxin therapy no later than 200 days after Autologous Stem Cell Transplantation (ASCT).
Written informed consent / assent was obtained in accordance with institutional and International Conference on Harmonisation (ICH) guidelines.
You may not be if
Patient had received prior anti-disialoganglioside (anti-GD2) antibody therapy.
Patient had participated in an investigational clinical trial with tumor therapeutic intent within 30 days of informed consent.
Patient underwent Autologous Stem Cell Transplantation (ASCT) more than 200 days prior to receiving Unituxin therapy.
Clareo Health | Post-Marketing Assessment of Immunogenicity and Safety of Unituxin® in High-Risk Neuroblastoma Patients
