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
干预措施
试验速览
- 阶段
- 不适用
- 状态
- 终止
- 入组人数
- 3
- 试验地点
- 1
- 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
- •Patients of any age who have previously undergone allogeneic hematopoietic transplantation and have evidence of donor cell engraftment (>20% donor cell within three months of study entry)
- •Expected survival >4 weeks
- •CML patients with molecular, cytogenetic or hematologic relapse following allogeneic transplantation
- •Molecular relapse- patients are eligible if bcr/abl is detectable at any time after day 180 post-allogeneic transplantation or if a negative bcr/abl PCR test was documented post-transplantation and the bcr/abl test is now positive by consecutive PCR determinations at least 4 weeks apart.
- •Cytogenetic relapse-patients are eligible if standard cytogenetics demonstrate >10% t (9,22) positive cells greater than 60 days after myeloablative transplantation or 10% t (9,22) positive cells greater than 100 days after nonmyeloablative transplantation.
- •CML patients with accelerated phase or blast crisis following allogeneic transplantation
- •Patients with CLL, NHL, MM, or HD who have evidence of disease relapse or persistent disease at 60 days post-allo BMT and/or:
- •MM- patients with a rising M-protein is detectable at 180 days post-transplant
- •NHL - patients with molecular evidence of disease (bcl-2, t (4,11), etc.) at 180 days post transplant
- •CLL, NHL or HD - patients with clear cut evidence of tumor growth at any time post-transplant are eligible
- •Patients undergoing an HLA -identical or 5/6 antigen match transplant from a related or unrelated donor
- •Patient's original donor must be available for lymphocyte donation
- •There must be no evidence of active acute or graft-versus-host disease and patients should be off all immunosuppressive agents for, at least, two weeks prior to DLI. Patients on stable dose of methylprednisolone (<16 mg/d) without evidence of active GVHD are also eligible.
- •Patients must have a Zubrod PS<2 (see appendix 7), Cr<2.5, bilirubin <3, and transaminases (SGPT, SGOT) <4x normal
- •Patient must be able to sign informed consent
排除标准
- 未提供
研究组 & 干预措施
CD8 DLI
Experimental
CD8 depleted DLI (Depleted Donor Lymphocyte Infusions)
干预措施: CD8 Depleted Donor Lymphocyte (Biological)
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 (1)
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