T Cell-Reduced Unrelated Donor Allogeneic Peripheral Blood Stem Cell Transplantation With Pentostatin and Low-Dose Total Body Irradiation
试验速览
- 阶段
- 1 期
- 状态
- 撤回
- 主要终点
- Stable donor engraftment
研究概览
简要总结
RATIONALE: Giving low doses of chemotherapy and total-body irradiation before a donor peripheral blood stem cell transplant helps stop the growth of cancer cells. It may also stop the patient's immune system from rejecting the donor's stem cells. The donated stem cells may replace the patient's immune cells and help destroy any remaining cancer cells (graft-versus-tumor effect). Sometimes the transplanted cells from a donor can also make an immune response against the body's normal cells. Removing the T cells from the donor cells before transplant and giving cyclosporine and mycophenolate mofetil after transplant may stop this from happening.
PURPOSE: This phase I/II trial is studying the side effects of giving a donor stem cell transplant after pentostatin and total-body irradiation and to see how well it works in treating patients with hematological cancer.
详细描述
OBJECTIVES:
Primary
- To determine the safety of pentostatin and low-dose total body irradiation followed by T-cell-reduced unrelated donor peripheral blood stem cell transplantation, in terms of regimen-related toxicity, in patients with hematological malignancies.
- To evaluate the efficacy of this regimen, measured as engraftment rate and establishment of donor hematopoietic chimerism, in these patients.
Secondary
- To determine the incidence of acute and chronic graft-versus-host disease in patients treated with this regimen.
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
- 19 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
Donor Stem Cell Transplant, Pentostatin & Total-Body Irradiation for Hematological Cancer
This phase I/II trial is studying the side effects of giving a donor stem cell transplant after pentostatin and total-body irradiation and to see how well it works in treating patients with hematological cancer.
干预措施: cyclosporine (Drug)
Donor Stem Cell Transplant, Pentostatin & Total-Body Irradiation for Hematological Cancer
This phase I/II trial is studying the side effects of giving a donor stem cell transplant after pentostatin and total-body irradiation and to see how well it works in treating patients with hematological cancer.
干预措施: mycophenolate mofetil (Drug)
Donor Stem Cell Transplant, Pentostatin & Total-Body Irradiation for Hematological Cancer
This phase I/II trial is studying the side effects of giving a donor stem cell transplant after pentostatin and total-body irradiation and to see how well it works in treating patients with hematological cancer.
干预措施: pentostatin (Drug)
Donor Stem Cell Transplant, Pentostatin & Total-Body Irradiation for Hematological Cancer
This phase I/II trial is studying the side effects of giving a donor stem cell transplant after pentostatin and total-body irradiation and to see how well it works in treating patients with hematological cancer.
干预措施: cytogenetic analysis (Genetic)
Donor Stem Cell Transplant, Pentostatin & Total-Body Irradiation for Hematological Cancer
This phase I/II trial is studying the side effects of giving a donor stem cell transplant after pentostatin and total-body irradiation and to see how well it works in treating patients with hematological cancer.
干预措施: fluorescence in situ hybridization (Genetic)
Donor Stem Cell Transplant, Pentostatin & Total-Body Irradiation for Hematological Cancer
This phase I/II trial is studying the side effects of giving a donor stem cell transplant after pentostatin and total-body irradiation and to see how well it works in treating patients with hematological cancer.
干预措施: protein analysis (Genetic)
Donor Stem Cell Transplant, Pentostatin & Total-Body Irradiation for Hematological Cancer
This phase I/II trial is studying the side effects of giving a donor stem cell transplant after pentostatin and total-body irradiation and to see how well it works in treating patients with hematological cancer.
干预措施: flow cytometry (Other)
Donor Stem Cell Transplant, Pentostatin & Total-Body Irradiation for Hematological Cancer
This phase I/II trial is studying the side effects of giving a donor stem cell transplant after pentostatin and total-body irradiation and to see how well it works in treating patients with hematological cancer.
干预措施: immunoenzyme technique (Other)
Donor Stem Cell Transplant, Pentostatin & Total-Body Irradiation for Hematological Cancer
This phase I/II trial is studying the side effects of giving a donor stem cell transplant after pentostatin and total-body irradiation and to see how well it works in treating patients with hematological cancer.
干预措施: laboratory biomarker analysis (Other)
Donor Stem Cell Transplant, Pentostatin & Total-Body Irradiation for Hematological Cancer
This phase I/II trial is studying the side effects of giving a donor stem cell transplant after pentostatin and total-body irradiation and to see how well it works in treating patients with hematological cancer.
干预措施: reduced-intensity transplant conditioning procedure (Other)
Donor Stem Cell Transplant, Pentostatin & Total-Body Irradiation for Hematological Cancer
This phase I/II trial is studying the side effects of giving a donor stem cell transplant after pentostatin and total-body irradiation and to see how well it works in treating patients with hematological cancer.
干预措施: nonmyeloablative allogeneic hematopoietic stem cell transplantation (Procedure)
Donor Stem Cell Transplant, Pentostatin & Total-Body Irradiation for Hematological Cancer
This phase I/II trial is studying the side effects of giving a donor stem cell transplant after pentostatin and total-body irradiation and to see how well it works in treating patients with hematological cancer.
干预措施: peripheral blood stem cell transplantation (PBSC) (Procedure)
Donor Stem Cell Transplant, Pentostatin & Total-Body Irradiation for Hematological Cancer
This phase I/II trial is studying the side effects of giving a donor stem cell transplant after pentostatin and total-body irradiation and to see how well it works in treating patients with hematological cancer.
干预措施: total-body irradiation (Radiation)
结局指标
主要结局
Stable donor engraftment
时间窗: by day 70
Stable donor engraftment
Severe transplant-related toxicity
时间窗: before day 100
Severe transplant-related toxicity (grade III-IV adverse events) as assessed by NCI CTCAE v2.0
Mortality
时间窗: at day 100
Death
次要结局
- Incidence of grade III-IV acute graft-versus-host disease(at day 100)