Transplantation of Unrelated Donor Umbilical Cord Blood in Patients With Hematological Malignancies Using a Non-Myeloablative Preparative Regimen
试验速览
- 阶段
- 2 期
- 状态
- 终止
- 入组人数
- 13
- 试验地点
- 1
- 主要终点
- Probability of Survival at 1 Year
研究概览
简要总结
RATIONALE: Giving low doses of chemotherapy and total-body irradiation before a donor umbilical cord blood transplant helps stop the growth of cancer or abnormal 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. Giving cyclosporine and mycophenolate mofetil before and after transplant may stop this from happening.
PURPOSE: This phase II trial is studying how well donor umbilical cord blood transplant with reduced intensity conditioning works in treating patients with advanced hematological cancer or other disease.
详细描述
OBJECTIVES:
Primary
- To estimate the probability of survival at 1 year in patients with advanced hematological malignancies or other diseases treated with non-myeloablative unrelated donor umbilical cord blood transplantation.
Secondary
- Six month non-relapse mortality.
- Chimerism at days 7, 14, 21, 28, 56, and 80, at 6 months, and at 1 and 2 years.
- To determine the incidence of neutrophil engraftment at day 42.
- To determine the incidence of platelet engraftment at 6 months.
- To determine the incidence of grade II-IV and III-IV acute graft-versus-host-disease (GVHD) at day 100.
- To determine the incidence of chronic GVHD at 1 year.
- To determine the incidence of clinically significant infections at 6 months and at 1 and 2 years.
- To determine the probability of progression-free survival at 1 and 2 years.
- To determine the probability of survival at 2 years.
- To determine the incidence of relapse or disease progression at 1 and 2 years.
研究设计
- 研究类型
- Interventional
- 分配方式
- Non Randomized
- 干预模型
- Parallel
- 主要目的
- Treatment
- 盲法
- None
入排标准
- 年龄范围
- — 至 69 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
Cyclophosphamide/Fludarabine/TBI
Subjects with hematological malignancies with prior autologous transplant, >2 cycles of multiagent chemotherapy, or severely immune suppressive therapy in last 3 months.
Refractory leukemia and lymphoma in aplasia after induction chemotherapy or radioimmunoconjugated monoclonal antibody therapy.
干预措施: cyclophosphamide (Drug)
Cyclophosphamide/Fludarabine/TBI
Subjects with hematological malignancies with prior autologous transplant, >2 cycles of multiagent chemotherapy, or severely immune suppressive therapy in last 3 months.
Refractory leukemia and lymphoma in aplasia after induction chemotherapy or radioimmunoconjugated monoclonal antibody therapy.
干预措施: cyclosporine (Drug)
Cyclophosphamide/Fludarabine/TBI
Subjects with hematological malignancies with prior autologous transplant, >2 cycles of multiagent chemotherapy, or severely immune suppressive therapy in last 3 months.
Refractory leukemia and lymphoma in aplasia after induction chemotherapy or radioimmunoconjugated monoclonal antibody therapy.
干预措施: fludarabine phosphate (Drug)
Cyclophosphamide/Fludarabine/TBI
Subjects with hematological malignancies with prior autologous transplant, >2 cycles of multiagent chemotherapy, or severely immune suppressive therapy in last 3 months.
Refractory leukemia and lymphoma in aplasia after induction chemotherapy or radioimmunoconjugated monoclonal antibody therapy.
干预措施: mycophenolate mofetil (Drug)
Cyclophosphamide/Fludarabine/TBI
Subjects with hematological malignancies with prior autologous transplant, >2 cycles of multiagent chemotherapy, or severely immune suppressive therapy in last 3 months.
Refractory leukemia and lymphoma in aplasia after induction chemotherapy or radioimmunoconjugated monoclonal antibody therapy.
干预措施: umbilical cord blood transplantation (Procedure)
Cyclophosphamide/Fludarabine/TBI
Subjects with hematological malignancies with prior autologous transplant, >2 cycles of multiagent chemotherapy, or severely immune suppressive therapy in last 3 months.
Refractory leukemia and lymphoma in aplasia after induction chemotherapy or radioimmunoconjugated monoclonal antibody therapy.
干预措施: total body irradiation (Radiation)
Cyclophosphamide/Fludarabine/TBI/ATG
Subjects with hematological malignancies with prior autologous transplant >12 mos or <1 cycle of multiagent chemotherapy or NO immune suppressive chemotherapy in last 3 months
干预措施: anti-thymocyte globulin (Biological)
Cyclophosphamide/Fludarabine/TBI/ATG
Subjects with hematological malignancies with prior autologous transplant >12 mos or <1 cycle of multiagent chemotherapy or NO immune suppressive chemotherapy in last 3 months
干预措施: cyclophosphamide (Drug)
Cyclophosphamide/Fludarabine/TBI/ATG
Subjects with hematological malignancies with prior autologous transplant >12 mos or <1 cycle of multiagent chemotherapy or NO immune suppressive chemotherapy in last 3 months
干预措施: cyclosporine (Drug)
Cyclophosphamide/Fludarabine/TBI/ATG
Subjects with hematological malignancies with prior autologous transplant >12 mos or <1 cycle of multiagent chemotherapy or NO immune suppressive chemotherapy in last 3 months
干预措施: fludarabine phosphate (Drug)
Cyclophosphamide/Fludarabine/TBI/ATG
Subjects with hematological malignancies with prior autologous transplant >12 mos or <1 cycle of multiagent chemotherapy or NO immune suppressive chemotherapy in last 3 months
干预措施: mycophenolate mofetil (Drug)
Cyclophosphamide/Fludarabine/TBI/ATG
Subjects with hematological malignancies with prior autologous transplant >12 mos or <1 cycle of multiagent chemotherapy or NO immune suppressive chemotherapy in last 3 months
干预措施: umbilical cord blood transplantation (Procedure)
Cyclophosphamide/Fludarabine/TBI/ATG
Subjects with hematological malignancies with prior autologous transplant >12 mos or <1 cycle of multiagent chemotherapy or NO immune suppressive chemotherapy in last 3 months
干预措施: total body irradiation (Radiation)
结局指标
主要结局
Probability of Survival at 1 Year
时间窗: 1 year post transplant
Kaplan-Meier estimate of the probability of survival at 1 year
次要结局
- Probability of Survival at 2 Years(2 years post transplant)
- Incidence of Non-relapse Mortality at 6 Months(6 months post transplant)
- Chimerism(7 days, 14 days, 21 days, 28 days, 56 days, and 80 days, 6 months, 1 and 2 years post transplant)
- Incidence of Neutrophil Engraftment at Day 42(Day 42 post transplant)
- Incidence of Platelet Engraftment at 6 Months(6 months post transplant)
- Incidence of Grade II-IV Acute Graft-versus-host-disease (GVHD) at Day 100(Day 100 post transplant)
- Incidence of Grade III-IV Acute Graft-versus-host-disease (GVHD) at Day 100(Day 100 post transplant)
- Incidence of Chronic Graft-versus-host-disease (GVHD) at 1 Year(1 year post transplant)
- Incidence of Clinically Significant Infections at 6 Months(6 months post transplant)
- Incidence of Clinically Significant Infections at 1 Year(1 year post transplant)
- Incidence of Clinically Significant Infections at 2 Years(2 years post transplant)
- Probability of Progression-free Survival at 1 Year(1 year post transplant)
- Probability of Progression-free Survival at 2 Years(2 years post transplant)
- Incidence of Relapse at 1 Year(1 year post transplant)
- Incidence of Relapse at 2 Years(2 years post transplant)
研究者
Colleen Delaney
Principal Investigator
Fred Hutchinson Cancer Center