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

United Therapeutics13 enrolled

Overview

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.

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.

Study Type

OBSERVATIONAL

Enrollment

Conditions

Neuroblastoma

Interventions

DinutuximabDRUG

Unituxin was administered along with cytokines according to the prescribing information

Eligibility

Sex: ALLMin age: 1 YearMax age: 18 Years

Medical Language ↔ Plain English

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.

Locations (18)

University Of Alabama At Birmingham

Birmingham, Alabama, United States

Arkansas Children's Hospital

Little Rock, Arkansas, United States

Outcomes

Primary Outcomes

To Determine the Incidence of Human Anti-chimeric Antibody (HACA) in High-risk Neuroblastoma Patients Treated With Unituxin Combination Therapy.

Seven blood samples were collected at the following time points for the evaluation of HACA levels: * Course 1- Prior to the first Unituxin infusion * Course 2- Prior to the first Unituxin infusion * Course 3- Prior to the first Unituxin infusion * Course 4- Prior to the first Unituxin infusion * Course 5- Prior to the first Unituxin infusion * Course 6- Prior to the first dose of 13-cis-retinoic acid (RA) * Study termination (approximately 2 weeks following the final 13-cis-retinoic acid dose)

Time frame: Approximately 6 months

Secondary Outcomes

To Determine the Incidence of Targeted Immune-related Adverse Events (AEs) During Treatment With Dinutuximab Combination Therapy in High-risk Neuroblastoma Subjects.

The incidence of targeted immune-related adverse events (AEs) during treatment with dinutuximab combination therapy in high-risk neuroblastoma subjects were summarized and listed.

Time frame: Approximately 6 months

To Determine the Incidence of Neutralizing Antibody (NAb) in Patients With Human Anti-chimeric Antibody (HACA) Positive Samples.

Incidence of neutralizing antibody (NAb) in patients with human anti-chimeric antibody (HACA) positive samples was summarized and listed.

Time frame: Approximately 6 months

To Determine the Effect of HACA on Dinutuximab Plasma Concentrations.

Ten blood samples were collected at the following time points for the evaluation of dinutuximab plasma concentrations: * Course 1- Prior to the first Unituxin infusion * Course 2- Prior to the first Unituxin infusion * Course 3- Prior to the first Unituxin infusion * Course 4- Prior to the first Unituxin infusion * Course 5- Prior to the first Unituxin infusion * Course 6- Prior to the first dose of 13-cis-retinoic acid (RA) * Study termination (approximately 2 weeks following the final 13-cis-retinoic acid dose). An additional 3 blood samples were obtained for the evaluation of dinutuximab plasma concentrations. Each of these blood samples was obtained immediately following the fourth dinutuximab infusion in Courses 1, 3, and 5.

Data from ClinicalTrials.gov

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