Allogeneic Bone Marrow Transplantation Using Closely Matched Related and Unrelated Donors
试验速览
- 阶段
- 2 期
- 状态
- 已完成
- 入组人数
- 72
- 试验地点
- 1
- 主要终点
- event free survival (EFS)
研究概览
简要总结
RATIONALE: Giving chemotherapy and total-body irradiation before a donor bone marrow 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 stem cells from a related or unrelated donor, that closely matches the patient's blood, are infused into the patient they may help the patient's bone marrow to make stem cells, red blood cells, white blood cells, and platelets.
PURPOSE: This phase II trial is studying how well donor bone marrow transplant works in treating patients with leukemia, lymphoma, or nonmalignant hematologic disorders.
详细描述
OBJECTIVES:
- Determine the survival of allogeneic bone marrow transplantation using closely matched related and unrelated donors in patients with malignant or nonmalignant hematological disorders.
- Determine the incidence and severity of acute and chronic graft versus host disease with this treatment regimen in these patients.
- Determine the relapse rates with this treatment regimen in those patients with malignant disorders.
- Determine the incidence and severity of infectious complications associated with this treatment regimen in these patients.
OUTLINE: Patients receive cyclophosphamide IV over 1 hour on days -6 and -5, total body radiotherapy on days -3 through 0, and allogeneic bone marrow transplantation on day 0.
Patients with acute lymphocytic leukemia (ALL) receive intrathecal methotrexate at the beginning of the study. If CNS involvement is documented, patients receive a second dose of methotrexate 48 hours later followed by oral leucovorin calcium every 6 hours for 4 doses. Patients with ALL and/or CNS involvement receive intrathecal methotrexate every other week for 12 weeks after transplant.
Patients with prior CNS involvement receive radiotherapy for 2.5 weeks prior to transplant. Patients with ALL receive total body radiotherapy for 5 consecutive days prior to transplant.
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 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
Cy/TBI
cyclophosphamide and total body irradiation (TBI)
干预措施: cyclophosphamide (Drug)
Cy/TBI
cyclophosphamide and total body irradiation (TBI)
干预措施: TBI (Radiation)
结局指标
主要结局
event free survival (EFS)
时间窗: five year post transplant
EFS determined by the Kaplan-Meier product limit method
次要结局
- Incidence of graft versus host disease(five years post transplant)