Allogeneic Hematopoietic Cell Transplantation for Patients With Acute Myelogenous Leukemia in Remission Using HLA-Matched Sibling Donors, HLA-Matched Unrelated Donors, or HLA-Mismatched Familial Donors - A Phase 2 Study
试验速览
- 阶段
- 2 期
- 状态
- 已完成
- 入组人数
- 263
- 试验地点
- 2
- 主要终点
- Efficacy of the treatment measured in terms of frequency of relapse and duration of remission
研究概览
简要总结
RATIONALE: Giving chemotherapy before a donor bone marrow or peripheral blood stem cell transplant helps stop the growth of cancer cells. It also helps stop the patient's immune system from rejecting the donor's stem 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 cyclosporine and methotrexate before and after transplant may stop this from happening.
PURPOSE: This phase II trial is studying how well donor stem cell transplant or bone marrow transplant works in treating patients with acute myeloid leukemia in remission.
详细描述
OBJECTIVES:
Primary
- Evaluate the efficacy of allogeneic hematopoietic stem cell transplantation (HSCT) or bone marrow transplantation (BMT) from a HLA-matched sibling donor, HLA-matched unrelated donor, or HLA-mismatched familial donor, in terms of the frequency of relapse and duration of remission, in patients with acute myeloid leukemia (AML) who have either achieved complete remission (CR1) after induction chemotherapy or who experienced recurrent AML then achieved second CR (CR2) after salvage chemotherapy.
Secondary
- Determine the engraftment, donor chimerism, and secondary graft failure in these patients.
- Assess acute and chronic graft-vs-host disease, immune recovery, and infections in these patients.
- Determine transplantation-related mortality, leukemia-free survival, and overall survival of these patients.
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
- 15 Years 至 75 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
transplantation
perform allogeneic HCT for patients with AML in CR1; then analyze various pre-transplantation variable, including donor type, for correlation to outcomes
干预措施: anti-thymocyte globulin (Biological)
transplantation
perform allogeneic HCT for patients with AML in CR1; then analyze various pre-transplantation variable, including donor type, for correlation to outcomes
干预措施: busulfan (Drug)
transplantation
perform allogeneic HCT for patients with AML in CR1; then analyze various pre-transplantation variable, including donor type, for correlation to outcomes
干预措施: cyclophosphamide (Drug)
transplantation
perform allogeneic HCT for patients with AML in CR1; then analyze various pre-transplantation variable, including donor type, for correlation to outcomes
干预措施: cyclosporine (Drug)
transplantation
perform allogeneic HCT for patients with AML in CR1; then analyze various pre-transplantation variable, including donor type, for correlation to outcomes
干预措施: fludarabine phosphate (Drug)
transplantation
perform allogeneic HCT for patients with AML in CR1; then analyze various pre-transplantation variable, including donor type, for correlation to outcomes
干预措施: methotrexate (Drug)
transplantation
perform allogeneic HCT for patients with AML in CR1; then analyze various pre-transplantation variable, including donor type, for correlation to outcomes
干预措施: allogeneic hematopoietic stem cell transplantation (Procedure)
结局指标
主要结局
Efficacy of the treatment measured in terms of frequency of relapse and duration of remission
时间窗: up to 2 years after transplantation
duration of CR, leukemia recurrence
次要结局
- Treatment-related mortality(up to 2 years after transplantation)
- Acute and chronic graft-versus-host disease(up to 100 days for acute GVHD and up to 2 years for chronic GVHD)
- Engraftment(up to 35 days after transplantation)
- Leukemia-free survival and overall survival(up to 2 years after transplantation)
研究者
Kyoo-Hyung Lee
Professor of Internal Medicine
Asan Medical Center