Post-Marketing Assessment of Immunogenicity and Safety of Unituxin® in High-Risk Neuroblastoma Patients

• Status: Terminated
• Trial end date: 2016-12-19
• Target enrollment: 0
• Participant gender: All

Summary

The purpose of this study was to assess the incidence of human anti-chimeric antibody (HACA) in high-risk neuroblastoma patients treated with Unituxin combination therapy.

• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: United Therapeutics
• Treatments: Antibodies, Monoclonal; Dinutuximab

Criteria

Inclusion Criteria:

• 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.

Exclusion Criteria:

• 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.