A Post-Marketing Study to Further Assess the Immunogenicity and Safety of Unituxin® in High-Risk Neuroblastoma Patients
试验速览
- 阶段
- 不适用
- 状态
- 终止
- 发起方
- 入组人数
- 13
- 试验地点
- 18
- 主要终点
- To Determine the Incidence of Human Anti-chimeric Antibody (HACA) in High-risk Neuroblastoma Patients Treated With Unituxin Combination Therapy.
研究概览
简要总结
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.
详细描述
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.
研究设计
- 研究类型
- Observational
- 观察模型
- Cohort
- 时间视角
- Prospective
入排标准
- 年龄范围
- 1 Year 至 18 Years（Child, Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •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.
排除标准
- •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.
研究组 & 干预措施
Dinutuximab administered for 5 cycles
High-risk neuroblastoma patient treated with Unituxin as standard of care
干预措施: Dinutuximab (Drug)
结局指标
主要结局
To Determine the Incidence of Human Anti-chimeric Antibody (HACA) in High-risk Neuroblastoma Patients Treated With Unituxin Combination Therapy.
时间窗: Approximately 6 months
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)
次要结局
- To Determine the Incidence of Neutralizing Antibody (NAb) in Patients With Human Anti-chimeric Antibody (HACA) Positive Samples.(Approximately 6 months)
- To Determine the Incidence of Targeted Immune-related Adverse Events (AEs) During Treatment With Dinutuximab Combination Therapy in High-risk Neuroblastoma Subjects.(Approximately 6 months)
- To Determine the Effect of HACA on Dinutuximab Plasma Concentrations.(Approximately 6 months)