Post Transplant Infusion of Allogeneic Cytokine Induced Killer Cells as Consolidative Therapy After Non-Myeloablative Allogeneic Transplantation in Patients With Myelodysplasia or Myeloproliferative Disorders
试验速览
- 阶段
- 2 期
- 状态
- 已完成
- 发起方
- 入组人数
- 44
- 试验地点
- 1
- 主要终点
- Full Donor Chimerism (FDC)
研究概览
简要总结
Allogeneic stem cell transplantation (transplant of blood cells from another individual) is a treatment option for patients with myelodysplasia or myeloproliferative Disorders. During the course of this study, it will be evaluated whether a particular type of blood cell, called a cytokine-induced killer (CIK) cell, may add benefit to allogeneic stem cell transplantation. CIK cells are present in small quantities in the bloodstream but their numbers can be expanded after a brief period of nurturing in a laboratory.
详细描述
Primary Objectives:
To determine the rate of conversion to FDC following infusion of allogeneic CIK cells among patients with MDS, therapy-related myeloid neoplasms, or MPD who receive non myeloablative preparative regimen of TLI / ATG followed by allogeneic HCT and consolidation with allogeneic CIK cells.
Secondary Objectives:
- To determine the 2 year overall survival (OS) and event free survival (EFS)
- To determine the incidence of acute GVHD following infusion of allogeneic CIK cells
- To assess the pre-transplant expression of NKG2D ligands in patients' bone marrow aspirates.
研究设计
- 研究类型
- Interventional
- 分配方式
- Na
- 干预模型
- Single Group
- 主要目的
- Treatment
- 盲法
- None
入排标准
- 年龄范围
- 50 Years 至 —（Adult, Older 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
Allogeneic Cytokine-induced Killer Cells (CIK)
Target dose of ≥ 5 x 10e6 CD34+ cells/kg of recipient body weight plus an additional 2 x10e9 mononuclear cells.
干预措施: CIK cells (Drug)
Allogeneic Cytokine-induced Killer Cells (CIK)
Target dose of ≥ 5 x 10e6 CD34+ cells/kg of recipient body weight plus an additional 2 x10e9 mononuclear cells.
干预措施: Cyclosporine (Drug)
Allogeneic Cytokine-induced Killer Cells (CIK)
Target dose of ≥ 5 x 10e6 CD34+ cells/kg of recipient body weight plus an additional 2 x10e9 mononuclear cells.
干预措施: Mycophenolate Mofetil (Drug)
Allogeneic Cytokine-induced Killer Cells (CIK)
Target dose of ≥ 5 x 10e6 CD34+ cells/kg of recipient body weight plus an additional 2 x10e9 mononuclear cells.
干预措施: Thymoglobulin (Drug)
Allogeneic Cytokine-induced Killer Cells (CIK)
Target dose of ≥ 5 x 10e6 CD34+ cells/kg of recipient body weight plus an additional 2 x10e9 mononuclear cells.
干预措施: Total Lymphoid Irradiation (TLI) (Radiation)
结局指标
主要结局
Full Donor Chimerism (FDC)
时间窗: 90 days
Proportion of patients achieving full donor T-cell chimerism (FDC) by on or before Day 90 post non-myeloablative allogeneic transplant with allogeneic cytokine-induced killer (CIK) cells will be determined. FDC is defined as the attainment of \>95% donor type CD3+ cells. The outcome will be reported as number of participants who achieved full donor chimerism, a number without dispersion.
次要结局
- Event-free Survival (EFS) Rate(2 years)
- Overall Survival (OS)(2 years)
- Number of Participants That Experience Grade 2 to 4 aGvHD Within 100 Days and 1 Year(1 year)
- Pre-transplant Expression of Natural-killer Group 2, Member D (NKG2D) Ligands(Pre-transplant)
研究者
Everett Meyer
Assistant Professor-Med
Stanford University