NCT00394381已完成1 期
Autologous Cytokine-induced Killer Cell Adoptive Immunotherapy for Acute Myeloid Leukemia and Myelodysplastic Syndrome
适应症
试验速览
- 阶段
- 1 期
- 状态
- 已完成
- 入组人数
- 17
- 试验地点
- 2
- 主要终点
- blood count changes
研究概览
简要总结
A phase I/II study to explore the feasibility and efficacy of autologous CIK cells in patients with acute myeloid leukemia (AML)/ high grade myelodysplastic syndrome (MDS)
- Group 1: As adjuvant therapy in minimal residual disease state after autologous PBSCT.
- Group 2: As an adoptive immunotherapy in untreated disease state when conventional therapy with curative intent is not applicable
详细描述
This is a Phase I /II study on the feasibility / efficacy of adoptive immunotherapy with autologous CIK cells for the following 2 groups of patients who have AML or high grade MDS :
- Group 1 patients in minimal residual disease state post autologous peripheral blood stem cell transplant ( PBSCT ), and
- Group 2 patients with untreated high grade MDS or AML, who are not fit for standard curative intent chemotherapy.
The CIK cells will be generated by leukapheresis from patients and cultured in GMP facilities. Four repeated infusions will be given for a target dose of 1x10e10 T cell per infusion.
Efficacy will be assessed by
- Disease free survival compared to historical control in group 1 given CIK cells post autologous PBSCT as adjuvant immunotherapy (n=20 over 3 years), and
- Effect on the peripheral or marrow leukemia cell load in group 2 patients given CIK cells as alternative therapy in place of chemotherapy (n=10).
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
- 12 Years 至 75 Years（Child, Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •For Group 1: AML or MDS post autologous peripheral blood or marrow stem cell transplant.
- •For Group 2: High grade MDS ( RAEB or RAEBIT ) or AML, whom the haematologist in charge has assessed and deemed unfit for chemotherapy with curative intent.Patients must have fairly stable white cell count requiring only low dose or no myelosuppressive medication
- •Patients must understand the trial nature of this treatment and accept the possible absence of benefit.
排除标准
- •uncontrolled infection
- •life expectancy less than 6 weeks.
- •Contraindication to undergo one session of leukapheresis for PBMNC harvesting
结局指标
主要结局
blood count changes
时间窗: three months
T lymphocyte subsets
时间窗: three months
T cell functions
时间窗: 3 months
adverse reactions
时间窗: 24 hour
次要结局
- relapse rate(5 year)
- survival(5 year)
研究者
研究点 (2)
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