Long-Term Follow-up Protocol for Subjects Treated With Gene-Modified T Cells
试验速览
- 阶段
- 2 期
- 状态
- 招募中
- 发起方
- Celgene
- 入组人数
- 1,541
- 试验地点
- 227
- 主要终点
- Incidence of delayed Adverse Events (AEs)
研究概览
简要总结
This is a prospective study for the long-term follow-up (LTFU) of safety and efficacy for all pediatric and adult participants exposed to Gene-modified (GM) T-cell therapy participating in a previous Celgene sponsored or Celgene alliance partner sponsored study.
Participants who received at least one infusion of GM T cells will be asked to enroll in this LTFU protocol upon either premature discontinuation from, or completion of the prior parent treatment protocol.
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
- •Received at least one gene-modified (GM) T-cell infusion in a previous Celgene sponsored, Juno Therapeutics, other affiliates of BMS, or Celgene alliance partner-sponsored trial, and have discontinued, or completed the post-treatment follow-up period in the parent treatment protocol, as applicable.
- •Must understand and voluntarily sign an Informed Consent Form/Informed Assent Form prior to any study-related assessments/procedures being conducted.
排除标准
- •Not Applicable
- •Other protocol-defined inclusion/exclusion criteria apply
研究组 & 干预措施
Participants exposed to Gene-modified (GM) T cell therapy
干预措施: Gene-modified (GM) T cell therapy (Genetic)
结局指标
主要结局
Incidence of delayed Adverse Events (AEs)
时间窗: Up to 15 years from last gene-modified (GM) T cell infusion
Analysis of vector integration sites
时间窗: Up to 15 years from last GM T cell infusion
Incidence of replication-competent lentiviruses
时间窗: Up to 15 years from last GM T cell infusion
Physical growth as assessed by physical examination (pediatric participants only)
时间窗: Up to 15 years from last GM T cells infusion or until Tanner Stage 5 is reached
Incidence of sexual maturation as assessed by the Tanner staging system (pediatric participants only)
时间窗: Up to 15 years from last GM T cells infusion or until Tanner Stage 5
Proportion of participants who progressed on the study: participants with original diagnosis of malignancies
时间窗: Up to 15 years from last GM T cells infusion
Overall Survival (participants with original diagnosis of malignancies)
时间窗: Up to 15 years from last GM T cells infusion
Persistence of GM T cell drug products
时间窗: Up to 15 years from last GM T cell infusion
次要结局
- Lymphocyte count (B-cell)(Up to 15 years)