Transplantation of Haploidentical CD34+ Purified Peripheral Blood Stem Cells With NK-Cell Add-Back Following Conditioning With Total Body Irradiation, Thiotepa, Fludarabine and OKT3
试验速览
- 阶段
- 2 期
- 状态
- 终止
- 入组人数
- 1
- 试验地点
- 4
- 主要终点
- Risk of Developing Grades III-IV Acute Graft-vs-host Disease (GVHD)
研究概览
简要总结
RATIONALE: Giving chemotherapy and total-body irradiation before a donor peripheral blood stem cell and donor natural killer cell transplant helps stop the growth of cancer and abnormal cells and helps stop the patient's immune system from rejecting the donor's stem cells. When certain stem cells from a donor are infused into the patient they may help the patient's bone marrow make stem cells, red blood cells, white blood cells, and platelets. Sometimes the transplanted cells from a donor can make an immune response against the body's normal cells. Removing the T cells from the donor cells before transplant may stop this from happening.
PURPOSE: This phase II trial is studying how well giving a donor peripheral stem cell transplant and a donor natural killer cell transplant after total-body irradiation, thiotepa, fludarabine, and muromonab-CD3 works in treating patients with leukemia or other blood diseases.
详细描述
OBJECTIVES:
Primary
- Determine the effect of haploidentical donor CD34+ purified peripheral blood stem cells and donor natural killer (NK) cells on the risk of developing grades III-IV acute graft-vs-host disease in patients with leukemia or other hematologic diseases.
Secondary
- Determine the risk for mortality from infection before day 180 in patients treated with this regimen.
- Determine the risk for graft rejection in patients treated with this regimen.
- Determine the risk for life-threatening infections in patients treated with this regimen.
- Determine the concentration of subsets of NK, NK-T, T cells, and dendritic cells in the CD34+ NK/NK-T-enriched graft.
- Determine cytomegalovirus-specific T-cells in product and donor graft.
- Determine the genotype and phenotype of donor killer cell immunoglobulin-like receptor expression according to time after hematopoietic stem cell transplantation (HSCT).
- Determine the reconstitution of NK function according to time after HSCT.
- Determine the expression of NKG2 ligands of leukemic blasts.
研究设计
- 研究类型
- Interventional
- 主要目的
- Treatment
- 盲法
- None
入排标准
- 年龄范围
- — 至 45 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
结局指标
主要结局
Risk of Developing Grades III-IV Acute Graft-vs-host Disease (GVHD)
时间窗: Up to day 100
Count of participants with acute GVHD grades III-IV.
次要结局
- Risk for Life-threatening Infections(Up to day 100)
- Risk for Mortality From Infection Before Day 180(Up to day 180)
- Risk for Graft Failure(Engraftment documented day +20)
- Concentration of NK, NK-T, T-cells, and Dendritic Cell Subsets in the CD34+ NK/NK-T-enriched Graft(Up to 5 years)
- Cytomegalovirus-specific T Cells in Product and Donor Graft(Up to 5 years)
- Genotype and Phenotype of Donor Killer Cell Immunoglobulin-like Receptor Expression According to Time After Hematopoietic Stem Cell Transplantation (HSCT)(Up to 5 years)
- Reconstitution of NK Function According to Time After HSCT(Up to 5 years)
- Expression of NKG2 Ligands of Leukemic Blasts(Up to 5 years)
研究者
Ann Woolfrey
Principal Investigator
Fred Hutchinson Cancer Center