Phase 1/2 Study of Cord Blood Transplantation From Unrelated Donor for Adult Patients With Hematologic Malignancies Using Myeloablative Conditioning Regimen
试验速览
- 阶段
- 1 期
- 状态
- 已完成
- 入组人数
- 33
- 试验地点
- 2
- 主要终点
- Non-relapse mortality at 1 year
研究概览
简要总结
The primary purpose of this study is to evaluate the safety and efficacy of cord blood transplantation for adult patients with hematologic malignancies including refractory acute leukemia. The transplant procedure was determined in detail according to the previously published report showing a high survival, so that the investigators could expect a similar result.
详细描述
Although cord blood is considered as an alternative donor source for allogeneic hematopoietic stem cell transplantation, its procedure has yet to be standardized. Recently, a single institute result of cord blood transplantation for adult patients with hematologic malignancies have been reported by Takahashi et al (Blood 2004:104;3813-3820), in which the survival was significantly better than that of bone marrow transplantation from unrelated donor. The purpose of this study was to reevaluate the safety and efficacy of cord blood transplantation for adult patients with hematologic malignancies using the same transplant procedures in a multi-institutional setting.
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
- 20 Years 至 55 Years（Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Clinical diagnosis of acute leukemia, chronic myelogenous leukemia, and myelodysplastic syndrome
- •Lack of HLA-identical or 1 locus mismatched related donor
- •Age over 20, and under 55
- •Performance status 0 or 1
- •No moderate or sever organ dysfunction (liver, kidney, heart, lungs)
- •No anti-HLA antibody
- •Informed consent was obtained
排除标准
- •Uncontrollable diabetes
- •Uncontrollable hypertension
- •Active infection
- •TPHA, HBs-Ag, HCV-Ab positive
- •HTLV-I, HIV positive
结局指标
主要结局
Non-relapse mortality at 1 year
时间窗: 1 year
次要结局
- Engraftment(day 56)
- Disease free survival(1 year)
- Overall survival(1 year)
- Incidence of acute and chronic graft-versus-host disease(day100 and 1 year)
- Incidence of infectious complication(1year)
- Duration of hospitalization(1 year)
- Immune reconstitution after transplantation(1 year)
研究者
Takehiko Mori, M.D., Ph.D.
Dr.
Keio University