NCT00038818终止不适用
CD8 Depleted Donor Lymphocyte Infusions for Patients With Relapse Or Residual Disease Following Allogeneic Stem Cell Transplantation
适应症
试验速览
- 阶段
- 不适用
- 状态
- 终止
- 入组人数
- 3
- 试验地点
- 2
- 主要终点
- Patient Response Rates of Acute or Chronic GVHD
研究概览
简要总结
Primary Objectives:
To evaluate response rates of acute or chronic Graft-versus-host disease (GVHD) following CD8 depleted DLI (Depleted Donor Lymphocyte Infusions) in patients with Chronic myelomonocytic leukemia (CMML), chronic lymphoid leukemia (CLL), Non-Hodgkin's lymphoma (NLM), Multiple Myeloma (MM) and Hodgkin's Lymphoma (HD).
Secondary Objectives:
- To evaluate safety and treatment related mortality after CD8 depleted DLI.
- To evaluate the time to onset of GVHD following DLI and response to GVHD treatment.
- To evaluate the incidence and timing of pancytopenia following DLI.
- To evaluate disease-free survival, overall survival and relapse rates in three cohorts of patients; early relapse CML, late relapse CML and lymphoproliferative disorders (HD, CLL, NHL and MM).
- To evaluate the need and efficacy of second or subsequent CD8 depleted donor lymphocyte infusions.
- To evaluate the number of apheresis procedures needed to collect appropriate doses of CD4+ cells.
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
- 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
结局指标
主要结局
Patient Response Rates of Acute or Chronic GVHD
时间窗: 2 years
次要结局
未报告次要终点
研究者
研究点 (2)
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