Allogeneic Sibling and Unrelated Donor Hematopoietic Cell Transplantation for Patients With Hematologic Malignancies Using Busulfan, Etoposide and Cyclophosphamide
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 120
- 试验地点
- 2
- 主要终点
- efficacy of therapy
研究概览
简要总结
The purpose of this study is to determine the tolerability and efficacy in treating patients aged 51-60 with acute leukemia and in treating myelodysplastic syndromes (MDS) or myeloproliferative disorders (MPD).
详细描述
To learn whether a new preparative regimen to prepare patients for bone marrow transplantation is useful in patients above 50 years of age and whether it is useful in patients with myelodysplastic syndromes.
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
- 51 Years 至 60 Years（Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Patients aged 51-60 with acute non-lymphocytic leukemia in first or subsequent remission and acute lymphocytic leukemia in first remission with high risk features which include elevated white blood cell count at presentation, cytogenetic abnormalities, extramedullary leukemia, ALL in greater than first remission and patients with chronic myelogenous leukemia at any stage who have a histocompatible sibling donor.
- •Patients with myelodysplastic syndrome including patients with refractory anemia with excess blasts or refractory anemia with excess blasts in transformation.
- •Patients with myeloproliferative disorders which give them poor long-term disease-free survival, such as myeloid metaplasia or myeloid fibrosis.
- •Patients with secondary myelodysplasia following cytotoxic chemotherapy.
排除标准
- •Organ dysfunction
研究组 & 干预措施
CIK cell
The initial dose utilized will be 1x107 expanded cells/kg. The dose will be increased to 5x107 expanded cells/kg and 1x108 expanded cells/kg in successive escalations based on no significant infusional toxicity or GVHD.
干预措施: ablative allogeneic hematopoietic cell transplantation (Procedure)
结局指标
主要结局
efficacy of therapy
tolerability
次要结局
- compare efficacy of this treatment to historical controls
研究者
Robert Negrin
Professor of Lymphatic Research and Medicine
Stanford University