Minimal Ablation and Cellular Immune Therapy of Chronic Lymphocytic Leukemia, Prolymphocytic Leukemia, Low-Grade Non-Hodgkin's Lymphoma, and Mantle Cell Lymphoma With Allogeneic Donor Stem Cells
试验速览
- 阶段
- 2 期
- 状态
- 已完成
- 发起方
- 入组人数
- 47
- 试验地点
- 19
- 主要终点
- Treatment-related mortality within the first 6 months post-transplant
研究概览
简要总结
RATIONALE: Giving chemotherapy drugs, such as fludarabine and cyclophosphamide, before a donor peripheral blood stem cell transplant helps stop the growth of cancer cells. It also helps stop the patient's immune system from rejecting the donor's stem cells. When the healthy stem cells from a donor are infused into the patient they may help the patient's bone marrow make stem cells, red blood cells, white blood cells, and platelets.
PURPOSE: This phase II trial is studying how well fludarabine and cyclophosphamide followed by peripheral stem cell transplant works in treating patients with leukemia or lymphoma.
详细描述
OBJECTIVES:
- Determine the feasibility of fludarabine and cyclophosphamide followed by allogeneic peripheral blood stem cell transplantation, in terms of 6-month treatment-related mortality, in patients with chronic lymphocytic leukemia, prolymphocytic leukemia, low-grade non-Hodgkin's lymphoma, or mantle cell lymphoma.
- Determine the 6-month and 12-month probabilities of response in patients treated with this regimen.
- Determine the time to disease progression in patients responding to this regimen.
- Determine the percentage of donor chimerism achieved in patients treated with this regimen.
- Determine the risk of acute and chronic graft-versus-host disease in patients treated with this regimen.
- Determine the toxic effects of this regimen in these patients.
- Determine the overall survival and disease-free survival of patients treated with this regimen.
OUTLINE: This is a multicenter study.
Patients receive fludarabine IV over 30 minutes on days -7 to -3 and cyclophosphamide IV over 1 to 2 hours on days -5 to -3. Patients undergo allogeneic peripheral blood stem cell transplantation on days 0-1. Patients then receive filgrastim (G-CSF) subcutaneously daily beginning on day 5 and continuing until blood counts recover.
Patients with no signs of active graft-versus host disease and stable or progressive disease receive donor lymphocytes IV over 2 hours beginning after day 120. Patients may receive a total of 3 infusions at least 8 weeks apart if disease remains stable or progressive.
研究设计
- 研究类型
- Interventional
- 分配方式
- Non Randomized
- 干预模型
- Single Group
- 主要目的
- Treatment
- 盲法
- None
入排标准
- 年龄范围
- — 至 69 Years（Child, 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 Stem Cell Tx
minimal ablation and cellular immune therapy with allogeneic donor stem cell therapy
干预措施: fludarabine phosphate (Drug)
Allogeneic Stem Cell Tx
minimal ablation and cellular immune therapy with allogeneic donor stem cell therapy
干预措施: Cyclophosphamide (Drug)
Allogeneic Stem Cell Tx
minimal ablation and cellular immune therapy with allogeneic donor stem cell therapy
干预措施: PBSC (Biological)
Allogeneic Stem Cell Tx
minimal ablation and cellular immune therapy with allogeneic donor stem cell therapy
干预措施: G-CSF (Drug)
Allogeneic Stem Cell Tx
minimal ablation and cellular immune therapy with allogeneic donor stem cell therapy
干预措施: Donor lymphocytes (Biological)
结局指标
主要结局
Treatment-related mortality within the first 6 months post-transplant
时间窗: 6 months post chemo initiation
次要结局
- Response(6 months & 12 months)
- Percentage of patients achieving complete donor chimerism or mixed donor chimerism(90 days post transplant)
- Survival(5 years post study entry)