Pilot Study of Umbilical Cord Blood Transplantation in Adult Patients With Advanced Hematopoietic Malignancies
试验速览
- 阶段
- 1 期
- 状态
- 已完成
- 入组人数
- 5
- 试验地点
- 1
- 主要终点
- Determine the safety and feasibility of performing donor umbilical cord blood transplantation (UCBT) in patients with advanced hematologic malignancies
研究概览
简要总结
RATIONALE: Giving chemotherapy, such as fludarabine, busulfan, and etoposide, before a donor umbilical cord blood stem cell transplant helps stop the growth of cancer 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 antithymocyte globulin before transplant and tacrolimus and prednisone after transplant may stop this from happening.
PURPOSE: This phase I trial is studying how well donor umbilical cord blood transplant works in treating patients with advanced hematologic cancer.
详细描述
OBJECTIVES:
Primary
- Determine the safety and feasibility of performing donor umbilical cord blood transplantation (UCBT) in patients with advanced hematologic malignancies, in terms of > 80% engraftment rate at day 100 post-transplant and ≤ 50% transplant-related mortality.
Secondary
- Determine the toxicity of a myeloablative preparative regimen comprising busulfan, fludarabine, and etoposide prior to UCBT in these patients.
- Determine the neutrophil and platelet recovery in patients treated with this regimen.
- Determine the event-free and overall survival of patients treated with this regimen.
- Evaluate lineage-specific chimerism after UCBT and assess the contribution of each individual cord blood unit to post-transplantation hematopoiesis in these patients.
- Determine the incidence, severity, and timing of acute and chronic graft-vs-host disease in patients treated with this regimen.
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 55 Years（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
干预措施: etoposide (Drug)
cord blood transplant
干预措施: anti-thymocyte globulin (Biological)
cord blood transplant
干预措施: sargramostim (Biological)
cord blood transplant
干预措施: busulfan (Drug)
cord blood transplant
干预措施: fludarabine phosphate (Drug)
cord blood transplant
干预措施: prednisone (Drug)
cord blood transplant
干预措施: tacrolimus (Drug)
cord blood transplant
干预措施: allogeneic hematopoietic stem cell transplantation (Procedure)
cord blood transplant
干预措施: umbilical cord blood transplantation (Procedure)
结局指标
主要结局
Determine the safety and feasibility of performing donor umbilical cord blood transplantation (UCBT) in patients with advanced hematologic malignancies
时间窗: up to 24 months post-transplant
Determine the safety and feasibility of performing donor umbilical cord blood transplantation (UCBT) in patients with advanced hematologic malignancies, in terms of \> 80% engraftment rate at day 100 post-transplant and ≤ 50% transplant-related mortality.
次要结局
未报告次要终点