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

United Therapeutics

Status: Terminated

Conditions: Neuroblastoma

Treatments: Drug: Dinutuximab

Study type: Observational

Funder types: Industry

Identifiers

NCT02693171

DIV-NB-401

Details and patient eligibility

About

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.

Full description

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.

Enrollment: 13 patients

Sex: All

Ages: 1 to 18 years old

Volunteers: No Healthy Volunteers

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.

Trial design

13 participants in 1 patient group

Dinutuximab administered for 5 cycles

Description:

High-risk neuroblastoma patient treated with Unituxin as standard of care

Treatment:

Drug: Dinutuximab