Non-Myeloablative Allogeneic Hematopoietic Peripheral Blood Stem Cell Transplantation for Hematologic Malignancies and Disorders
试验速览
- 阶段
- 2 期
- 状态
- 已完成
- 入组人数
- 41
- 试验地点
- 1
- 主要终点
- Day 100 Best Response
研究概览
简要总结
RATIONALE: Giving low doses of chemotherapy before a donor peripheral blood stem cell transplant helps stop the growth of cancer cells. It also stops the patient's immune system from rejecting the donor's stem cells. The donated stem cells may replace the patient's immune system and help destroy any remaining cancer cells (graft-versus-tumor effect). Giving an infusion of the donor's T cells (donor lymphocyte infusion) after the transplant may help increase this effect. Sometimes the transplanted cells from a donor can also make an immune response against the body's normal cells. Giving immunosuppressive therapy before or after the transplant may stop this from happening.
PURPOSE: This phase II trial is studying how well chemotherapy followed by donor peripheral stem cell transplant works in treating patients with hematologic cancer or aplastic anemia.
详细描述
OBJECTIVES:
- Determine the safety and toxic effects of nonmyeloablative allogeneic peripheral blood stem cell transplantation in patients with a hematologic malignancy or aplastic anemia.
- Determine clinical response and overall outcome of patients treated with this regimen.
- Determine the incidence of graft-vs-tumor effect, graft-vs-host disease, and chimerism in patients treated with this regimen.
OUTLINE:
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Preparative regimen:
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Matched related and unrelated donor transplantation:
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
- 4 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
All patients
All patients enrolled on study
干预措施: anti-thymocyte globulin (Biological)
All patients
All patients enrolled on study
干预措施: graft-versus-tumor induction therapy (Biological)
All patients
All patients enrolled on study
干预措施: sargramostim (Biological)
All patients
All patients enrolled on study
干预措施: therapeutic allogeneic lymphocytes (Biological)
All patients
All patients enrolled on study
干预措施: cyclophosphamide (Drug)
All patients
All patients enrolled on study
干预措施: fludarabine phosphate (Drug)
All patients
All patients enrolled on study
干预措施: methylprednisolone (Drug)
All patients
All patients enrolled on study
干预措施: mycophenolate mofetil (Drug)
All patients
All patients enrolled on study
干预措施: tacrolimus (Drug)
All patients
All patients enrolled on study
干预措施: allogeneic bone marrow transplantation (Procedure)
All patients
All patients enrolled on study
干预措施: peripheral blood stem cell transplantation (Procedure)
All patients
All patients enrolled on study
干预措施: umbilical cord blood transplantation (Procedure)
结局指标
主要结局
Day 100 Best Response
时间窗: from start of conditioning on day -6 or -5 through day +100 after HSC infusion
Best disease response measured within 100 days from hematopoietic stem cell (HSC) infusion on day 0 using disease specific response criteria defined in the protocol
Day 100 TRM
时间窗: from start or conditioning (day -6 or -5) through day +100 after HSC infusion
treatment related mortality within 100 days from hematopoietic stem cell (HSC) infusion on day 0
次要结局
- PFS(1 year)
- Acute GvHD(Day +100)
- OS(1 year)