NCT00301951已完成1 期
Pilot Study of Reduced-Intensity Umbilical Cord Blood Transplantation in Adult Patients With Advanced Hematopoietic Malignancies
适应症
干预措施
相关药物
试验速览
- 阶段
- 1 期
- 状态
- 已完成
- 入组人数
- 7
- 试验地点
- 1
- 主要终点
- Safety and Feasibility of donor cord blood transplant
研究概览
简要总结
RATIONALE: Giving chemotherapy before a donor umbilical cord blood transplant helps stop both the growth of cancer cells and 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. Sometimes the transplanted cells from a donor can make an immune response against the body's normal cells. Giving chemotherapy, such as fludarabine and busulfan, and antithymocyte globulin before transplant and tacrolimus and mycophenolate mofetil after transplant may stop this from happening.
PURPOSE: This clinical trial is studying how well giving low-dose fludarabine and busulfan together with anti-thymocyte globulin, followed by donor umbilical cord blood transplant works in treating patients with advanced hematologic cancer.
详细描述
OBJECTIVES:
Primary
- Assess the feasibility of performing umbilical cord blood transplants in older patients or younger infirm patients with advanced hematologic malignancies using a reduced-intensity preparative regimen, as determined by > 80% engraftment rate at day 180 and a < 50% transplant-related mortality rate at day 100.
Secondary
- Describe the time to neutrophil and platelet recovery in patients treated with this regimen.
- Determine disease-specific, event-free, and overall survival rate at days 180 and 360.
- Determine the incidence, severity, and timing of acute and chronic graft-versus-host disease in patients treated with this regimen.
- Evaluate T-cell, B-cell, and natural killer cell recovery in patients treated with this regimen.
- Assess lineage-specific chimerism after transplantation and describe the contribution of each individual cord blood unit to post-transplantation hematopoiesis.
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 70 Years（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
cord blood transplant
Experimental
干预措施: anti-thymocyte globulin (Biological)
cord blood transplant
Experimental
干预措施: sargramostim (Biological)
cord blood transplant
Experimental
干预措施: busulfan (Drug)
cord blood transplant
Experimental
干预措施: fludarabine phosphate (Drug)
cord blood transplant
Experimental
干预措施: mycophenolate mofetil (Drug)
cord blood transplant
Experimental
干预措施: tacrolimus (Drug)
cord blood transplant
Experimental
干预措施: umbilical cord blood transplantation (Procedure)
结局指标
主要结局
Safety and Feasibility of donor cord blood transplant
时间窗: up to 36 months post transplant
as determined by \> 80% engraftment rate at day 180 and a \< 50% transplant-related mortality rate at day 100
次要结局
未报告次要终点
研究者
研究点 (1)
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