Long-term Follow-up Study of Patients Receiving CAR-T Cells
试验速览
- 阶段
- 不适用
- 状态
- 招募中
- 入组人数
- 500
- 试验地点
- 1
- 主要终点
- Change from baseline in the incidence of a new malignancy at 5 years.
研究概览
简要总结
This protocol is designed as a long-term follow-up study of participants who will receive CAR-T cells as part of a clinical trial at the Medical College of Wisconsin/ Froedtert Hospital. The clinical trials include the following:
Phase 1 Study of CAR-20/19-T Cells in Patients with Relapsed Refractory B Cell Malignancies (NCT03019055); Phase I Trial of BCMA-TGF-BETA CAR-T Cells in Relapsed, Refractory Myeloma (NCT05976555); CAR20.19.22 T-cells in Relapsed, Refractory B-cell Malignancies (NCT05094206); LV20.19 CAR T-Cells in Combination With Pirtobrutinib for Relapsed, Refractory B-cell Malignancies (NCT05990465); CAR-20/19-T Cells in Patients With Relapsed Refractory B Cell Malignancies (NCT04186520)
详细描述
The objective is to follow participants receiving CAR-T cells from years 2 to 15 post-treatment for persistence of CAR-T cells, development of secondary malignancies, or other medical complications.
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
- 18 Years 至 80 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •All participants who enrolled in a CAR-T study at Froedtert Hospital & the Medical College of Wisconsin.
排除标准
- •There are no exclusion criteria for this study.
结局指标
主要结局
Change from baseline in the incidence of a new malignancy at 5 years.
时间窗: Baseline to five years.
The number of subjects with new malignancy.
Change from baseline in the incidence of a new malignancy at 10 years.
时间窗: Baseline to 10 years.
The number of subjects with new malignancy.
Change from baseline in the incidence of a new malignancy at 15 years.
时间窗: Baseline to 15 years.
The number of subjects with new malignancy.
次要结局
未报告次要终点
研究者
Nirav Shah
Associate Professor
Medical College of Wisconsin