NCT00080925已完成1 期
T-Cell Depleted, Reduced-Intensity Allogeneic Stem Cell Transplantation From Haploidentical Related Donors For Hematologic Malignancies
适应症
相关药物
试验速览
- 阶段
- 1 期
- 状态
- 已完成
- 入组人数
- 20
- 试验地点
- 2
研究概览
简要总结
RATIONALE: Donor peripheral stem cell transplantation may be able to replace bone marrow and immune cells that were destroyed by chemotherapy. Sometimes the transplanted cells from a donor are rejected by the body's normal cells. Eliminating the T cells from the donor cells before transplanting them and giving cyclosporine may prevent this from happening.
PURPOSE: This phase I trial is studying the side effects of T-cell-depleted allogeneic stem cell transplantation after immunoablative induction chemotherapy and reduced-intensity transplantation conditioning (chemotherapy) in treating patients with hematologic malignancies.
详细描述
OBJECTIVES:
Primary
- Determine engraftment in patients with hematologic malignancies treated with T-cell-depleted allogeneic stem cell transplantation after immunoablative induction chemotherapy and reduced-intensity transplantation conditioning.
Secondary
- Determine the incidence of acute graft-versus-host disease (GVHD), and nonrelapse mortality (within 100 days after transplantation) in these patients.
- Correlate levels of host immunosuppression before transplantation conditioning, as evaluated by peripheral blood CD4 counts, with graft rejection/failure within 100 days after transplantation and the level of donor hematopoietic chimerism 28 days after transplantation in these patients.
- Correlate donor-versus-recipient natural killer cell alloreactivity with graft rejection/failure, acute GVHD, and relapse of malignant disease in patients treated with this regimen.
- Determine the development of allospecific cytotoxic T-lymphocytes after transplantation in patients with myeloid or lymphoid leukemia.
- Correlate serum interleukin-7 and interleukin-15 levels with in vivo changes in host lymphocyte subpopulations in these patients during sequential immunoablative chemotherapy, before allogeneic stem cell transplantation, and during immune reconstitution after transplantation.
研究设计
- 研究类型
- Interventional
- 主要目的
- Treatment
入排标准
- 年龄范围
- 18 Years 至 55 Years（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
研究者
研究点 (2)
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