Nonmyeloablative Allogeneic Stem Cell Transplant for the Treatment of Hematologic Disorders
试验速览
- 阶段
- 2 期
- 状态
- 已完成
- 入组人数
- 25
- 主要终点
- durable engraftment
研究概览
简要总结
The purpose of this study is to provide allogeneic stem cell transplantation to patients who have not traditionally undergone this procedure because of it high incidence of treatment related side effects. We hope to decrease these side effects by decreasing the chemotherapy dose prior to transplant (non-myeloablative, smaller dose of chemotherapy given so bone marrow is not completely eliminated) and by using donated stem cells to treat cancer of the blood.
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 65 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
1
Study treatment arm with G-CSF
干预措施: Cyclophosphamide (Drug)
1
Study treatment arm with G-CSF
干预措施: fludarabine (Drug)
1
Study treatment arm with G-CSF
干预措施: cyclosporine (Drug)
1
Study treatment arm with G-CSF
干预措施: methotrexate (Drug)
1
Study treatment arm with G-CSF
干预措施: G-CSF (Biological)
结局指标
主要结局
durable engraftment
时间窗: 100 days
hematopoeitic reconstitution
时间窗: 3 years
evaluate the patterns of post-transplant chimerism among lymphoid and antigen presenting cells
时间窗: 3 years
次要结局
- disease free survival and overall survival(3 years)
- incidence of treatment related toxicity and acute and chronic graft versus host disease(100 days)
研究者
David McDermott
Associate Professor of Medicine
Beth Israel Deaconess Medical Center