Low-Dose Allogeneic Peripheral Blood Stem Cell Transplantation for High-Risk Low Grade Hematologic Malignancies
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 25
- 试验地点
- 2
- 主要终点
- Toxicity and survival
研究概览
简要总结
RATIONALE: Giving low doses of chemotherapy, such as fludarabine and busulfan, before a donor bone marrow or 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 antithymocyte globulin before transplant and methotrexate and tacrolimus after the transplant may stop this from happening.
PURPOSE: This phase I trial is studying the side effects of donor stem cell transplant in treating older or frail patients with hematologic cancer.
详细描述
OBJECTIVES:
Primary
- Determine the safety of non-myeloablative allogeneic peripheral blood stem cell transplantation, in terms of regimen-related organ toxicity and toxicity from acute graft-vs-host disease (GVHD), in older or medically frail patients with high-risk indolent hematologic malignancies.
- Determine overall survival, disease-free survival, and relapse risk at 1, 2, and 3 years post-transplantation in these patients.
Secondary
- Determine the engraftment of donor hematopoiesis at 6 weeks, 3 and 6 months, and 1 year post-transplantation in these patients.
- Determine the incidence and severity of chronic GVHD in older and medically infirm patients treated with this regimen.
- Determine the safety and efficacy of collecting peripheral blood stem cells from older donors (age > 60 years).
- Determine the need and efficacy of donor lymphocyte infusions in patients with residual disease after transplant.
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
- 18 Years 至 75 Years（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
stem cell transplant
干预措施: methotrexate (Drug)
stem cell transplant
干预措施: anti-thymocyte globulin (Biological)
stem cell transplant
干预措施: filgrastim (Biological)
stem cell transplant
干预措施: therapeutic allogeneic lymphocytes (Biological)
stem cell transplant
干预措施: busulfan (Drug)
stem cell transplant
干预措施: fludarabine phosphate (Drug)
stem cell transplant
干预措施: tacrolimus (Drug)
stem cell transplant
干预措施: nonmyeloablative allogeneic hematopoietic stem cell transplantation (Procedure)
stem cell transplant
干预措施: peripheral blood stem cell transplantation (Procedure)
结局指标
主要结局
Toxicity and survival
时间窗: up to 36 months post transplant
次要结局
未报告次要终点