Allogeneic Hematopoietic Stem Cell Transplantation From an HLA-partially Matched Related or Unrelated Donor After TCR αβ+T Cells/CD19+ B Cell Depletion in Children and Young Adults Affected by Malignant or Non-Malignant Hematological Disorders
试验速览
- 阶段
- 不适用
- 状态
- 招募中
- 发起方
- 入组人数
- 204
- 试验地点
- 1
- 主要终点
- Number of participants with grade II-IV acute GvHD after HSCT
研究概览
简要总结
The purpose of the CliniMACS® TCRαβ-Biotin System and CliniMACS® CD19 is to improve the safety and efficacy of allogeneic HLA-partially matched related or unrelated donors HSCT when no matched donors are available, to treat malignant and nonmalignant disorders for which HSCT is the recommended best available therapy. Initially this device will be used in a single-center, open-label, single-arm, phase II clinical trial to evaluate the efficacy of haploidentical PBSC grafts depleted of TCRα/β+ and CD19+ cells using the CliniMACS® TCRαβ/CD19 System in children and adults with hematological and non-hematological malignancies.
研究设计
- 研究类型
- Interventional
- 分配方式
- Non Randomized
- 干预模型
- Parallel
- 主要目的
- Treatment
- 盲法
- None
入排标准
- 年龄范围
- 1 Month 至 60 Years（Child, Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- 未提供
排除标准
- 未提供
研究组 & 干预措施
Stem Cell Transplant -Malignant
The participant with a malignancy will undergo a stem cell transplant using donor cells that have been manipulated through an investigational device. Participants will be followed for outcomes for two years.
干预措施: Allogeneic Stem Cell Transplant (Biological)
Stem Cell Transplant -Malignant
The participant with a malignancy will undergo a stem cell transplant using donor cells that have been manipulated through an investigational device. Participants will be followed for outcomes for two years.
干预措施: CliniMACS TCR α/β Reagent Kit and CliniMACS CD19 (Device)
Stem Cell Transplant - Non-Malignant
The participant with a non-malignant disease will undergo a stem cell transplant using donor cells that have been manipulated through an investigational device. Participants will be followed for outcomes for two years.
干预措施: Allogeneic Stem Cell Transplant (Biological)
Stem Cell Transplant - Non-Malignant
The participant with a non-malignant disease will undergo a stem cell transplant using donor cells that have been manipulated through an investigational device. Participants will be followed for outcomes for two years.
干预措施: CliniMACS TCR α/β Reagent Kit and CliniMACS CD19 (Device)
Stem Cell Transplant - Compassionate
Patients with malignant or non-malignant disorders who do not qualify for experimental arms but who may still benefit from participation in this study may be enrolled in this arm.
干预措施: Allogeneic Stem Cell Transplant (Biological)
Stem Cell Transplant - Compassionate
Patients with malignant or non-malignant disorders who do not qualify for experimental arms but who may still benefit from participation in this study may be enrolled in this arm.
干预措施: CliniMACS TCR α/β Reagent Kit and CliniMACS CD19 (Device)
结局指标
主要结局
Number of participants with grade II-IV acute GvHD after HSCT
时间窗: Through Day 100 after HSCT
次要结局
- Leukemia-free survival after HSCT(1 and 2 years after HSCT)
- Number of participants with secondary graft failure at after HSCT(1 and 2 year after HSCT)
- Number of participants with grade III-IV acute GvHD after HSCT(Through Day 100 after HSCT)
- Incidence rate of primary graft failure after HSCT(Day 42 after HSCT)
- Incidence of moderate and severe chronic GvHD after HSCT(1 year after HSCT)
研究者
Alice Bertaina
Associate Professor of Pediatrics
Stanford University