A Prospective Trial to Evaluate the Role of In Vivo T Cell Depletion by Campath® (Alemtuzumab) in Reduction of Transplant Related Mortality in Transplantation From HLA-Class I or Class II Mismatched, Unrelated Donors
试验速览
- 阶段
- 1 期
- 状态
- 终止
- 入组人数
- 1
- 试验地点
- 2
- 主要终点
- Lowest Dose of Alemtuzumab Associated With Transplant-related Mortality
研究概览
简要总结
RATIONALE: Monoclonal antibodies, such as alemtuzumab, can find cancer cells and either kill them or deliver cancer-killing substances to them without harming normal cells. Giving chemotherapy drugs, such as busulfan and cyclophosphamide, before a donor 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 tacrolimus and methotrexate after the transplant may stop this from happening.
PURPOSE: This phase I/II trial is studying the best dose of alemtuzumab when given together with busulfan and cyclophosphamide followed by a donor stem cell transplant and to see how well it works in treating patients with hematologic cancer.
详细描述
OBJECTIVES:
Primary
- Identify the lowest dose of alemtuzumab that is associated with day 180 transplant-related mortality ≤ 45%.
Secondary
- Determine the incidence of life-threatening infection in patients receiving this treatment.
- Determine the incidence of grades III-IV acute graft-vs-host disease (GVHD) in patients receiving this treatment.
- Determine the survival at 1 year in patients receiving this treatment.
- Determine the incidence of disease relapse at 1 year in patients receiving this treatment.
- Determine the incidence of extensive chronic GVHD at 1 year in patients receiving this treatment.
- Determine the incidence of graft failure at day 100 in patients receiving this treatment.
研究设计
- 研究类型
- Interventional
- 主要目的
- Treatment
入排标准
- 年龄范围
- — 至 50 Years（Child, 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
Alemtuzumab
Alemtuzumab given together with busulfan and cyclophosphamide followed by a donor stem cell transplant.
干预措施: alemtuzumab (Biological)
Alemtuzumab
Alemtuzumab given together with busulfan and cyclophosphamide followed by a donor stem cell transplant.
干预措施: busulfan (Drug)
Alemtuzumab
Alemtuzumab given together with busulfan and cyclophosphamide followed by a donor stem cell transplant.
干预措施: cyclophosphamide (Drug)
Alemtuzumab
Alemtuzumab given together with busulfan and cyclophosphamide followed by a donor stem cell transplant.
干预措施: methotrexate (Drug)
Alemtuzumab
Alemtuzumab given together with busulfan and cyclophosphamide followed by a donor stem cell transplant.
干预措施: tacrolimus (Drug)
Alemtuzumab
Alemtuzumab given together with busulfan and cyclophosphamide followed by a donor stem cell transplant.
干预措施: allogeneic hematopoietic stem cell transplantation (Procedure)
Alemtuzumab
Alemtuzumab given together with busulfan and cyclophosphamide followed by a donor stem cell transplant.
干预措施: peripheral blood stem cell transplantation (Procedure)
结局指标
主要结局
Lowest Dose of Alemtuzumab Associated With Transplant-related Mortality
时间窗: Up to day 180
Lowest dose of alemtuzumab associated with transplant-related mortality at day 180
次要结局
- Life-threatening Infection(Up to 180 days)
- Grades III-IV Acute Graft-vs-host Disease (GVHD)(Up to 100 days)
- Overall Survival(Up to 1 year)
- Disease Relapse(Up to 1 year)
- Extensive Chronic GVHD(Up to 1 year)
- Graft Failure(Up to day 100)
研究者
Ann Woolfrey
Principal Investigator
Fred Hutchinson Cancer Center