Long-Term Follow-up of Patients Treated With Miltenyi Cell and Gene Therapies
试验速览
- 阶段
- 不适用
- 状态
- 招募中
- 入组人数
- 40
- 试验地点
- 7
- 主要终点
- Adverse Events
研究概览
简要总结
The goal of this Long-Term Follow-Up Trial is to assess long-term safety and efficacy of Miltenyi CAR T treatment.
详细描述
The focus in this trial is on the occurrence of any late adverse reactions (AR), serious adverse events (SAE), serious adverse reactions (SAR) and adverse events of special interest (AESI), i.e. relapse or progression of the underlying disease, life-threatening infections, death due to any case, new and secondary malignancies, lymphocyte counts, detection of the transgene of the CAR T cells, detection of replication-competent lentivirus (RCL), developmental tracking in pediatric patients and furthermore, assessment of the primary status of disease progression and overall survival.
研究设计
- 研究类型
- Interventional
- 分配方式
- Na
- 干预模型
- Single Group
- 主要目的
- Other
- 盲法
- None
入排标准
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Patient underwent treatment with a Miltenyi CAR T cell therapy in one of the parent trials at least 12 months prior to enrollment in long-term follow-up.
- •Patient has provided informed consent prior to enrollment.
排除标准
- •No exclusion criteria
研究组 & 干预措施
Long-term follow-up of CAR T cell therapy
Assessment of long-term safety and efficacy of Miltenyi CAR T treatment.
干预措施: MB-CART19.1 (Biological)
Long-term follow-up of CAR T cell therapy
Assessment of long-term safety and efficacy of Miltenyi CAR T treatment.
干预措施: MB-CART20.1 (Biological)
Long-term follow-up of CAR T cell therapy
Assessment of long-term safety and efficacy of Miltenyi CAR T treatment.
干预措施: MB-CART2019.1 (Biological)
结局指标
主要结局
Adverse Events
时间窗: through study completion, up to 14 years
Percentage of patients with late-onset adverse reactions (AR), serious adverse events (SAE), serious adverse reactions (SAR) and adverse events of special interest (AESI) including relapse or progression of the underlying disease, life-threatening infections, death due to any cause, new and secondary malignancies
次要结局
- Height(through study completion, up to 14 years)
- Relapse / Progression(through study completion, up to 14 years)
- Lymphocyte count(through study completion, up to 14 years)
- Weight(through study completion, up to 14 years)
- Detectable Transgene levels(through study completion, up to 14 years)
- Tanner staging for pediatric patients(through study completion, up to 14 years)
- Menstruation status for pediatric patients(through study completion, up to 14 years)
- RCL(through study completion, up to 14 years)