NCT00048100终止1 期
Anti-Leukemic Dendritic Cell Activated Donor Lymphocytes for Therapy of Relapsed Leukemia After Allogeneic Stem Cell Therapy
适应症
干预措施
试验速览
- 阶段
- 1 期
- 状态
- 终止
- 入组人数
- 2
- 试验地点
- 2
- 主要终点
- Participant Toxicity Levels
研究概览
简要总结
Objectives:
- Determine the toxicity of infusions of allogeneic donor lymphocytes activated by acute leukemia derived dendritic cells (DC/ADL) in relapsed patients after allo-stem cell transplants.
- Quantitate the alloreactivity of DC/ADL and circulating immune effector cells in patients after infusion.
- Assess efficacy of acute myelogenous leukemia (AML) or Chronic Myelogenous Leukemia in Blastic Crisis (CML-BC) derived dendritic cells and activated lymphocytes in promoting and sustaining remission in patients with relapse after allo-BMT or stem cell transplant.
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
- 18 Years 至 65 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •AML (any type except M3) or CIVIL in blast crisis with greater than or equal to 20% bone marrow blasts at the time of related donor marrow or stem cell transplantation or at relapse post transplant.
- •Willing to undergo a skin biopsy and either a leukodepletion apheresis or an additional marrow aspiration.
- •Stem cell or marrow donor willing to have apheresis for T-Cell collection.
- •Written voluntary informed consent must be obtained from patient and donor.
排除标准
- •Medical, social or psychologic factors which would prevent the patient from receiving or cooperating with the full course of therapy or understanding the informed consent procedure.
- •AML French-American-British (FAB) subtype M3.
研究组 & 干预措施
Apheresis + Transplant
Experimental
Skin biopsy & either a leukodepletion apheresis or an additional marrow aspiration prior to marrow or stem cell transplantation.
干预措施: Apheresis (Procedure)
Apheresis + Transplant
Experimental
Skin biopsy & either a leukodepletion apheresis or an additional marrow aspiration prior to marrow or stem cell transplantation.
干预措施: Stem Cell Transplant (Biological)
结局指标
主要结局
Participant Toxicity Levels
时间窗: From stem cell transplant baseline to 30 plus days post transplant.
Participant toxicity of infusions of allogeneic donor lymphocytes activated by acute leukemia derived dendritic cells (DC/ADL) in relapsed patients after allo-stem cell transplants.
次要结局
未报告次要终点
研究者
研究点 (2)
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