Pilot Study Of Haplo-Identical Natural Killer Cell Transplantation For Acute Myeloid Leukemia
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 49
- 试验地点
- 1
- 主要终点
- Number of Patients Experiencing Grade 3 or 4 Toxicities During Conditioning and up to 100 Days Post-transplant
研究概览
简要总结
The purpose of this study is to assess the safety and efficacy of infusing natural killer cells from a donor as treatment for patients with acute myeloid leukemia in remission or who have experienced relapse.
详细描述
Natural killer (NK) cells extracted from a [parental] donor are infused intravenously. Most patients are given a multi-agent chemotherapeutic conditioning regimen prior to the infusion. The conditioning regimen may be omitted for patients who have previously received traditional stem cell transplant.
Details of Treatment Plan:
Stratum 1 (AML in complete remission)
Cyclophosphamide 60 mg/kg IV Day -7 Fludarabine 25 mg/m2/day IV Days -6 through -2 Donor pheresis Day -1 Start IL-2 on Day -1, then 3 times per week x 2 weeks NK Cell purification and infusion on Day 0
Stratum 2 (AML that is refractory or relapsed or AML with increasing minimal residual disease)
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
- — 至 21 Years（Child, Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Participants with AML that is in complete remission, is relapsed or refractory, or with increasing minimal residual disease.
- •Participants in complete remission must have recovered from toxicity of previous therapy and have evidence of bone marrow recovery
- •Participants who had prior stem cell transplant (SCT) must have no evidence of GVHD and 60 or more days have elapsed since the SCT.
排除标准
- •Participants who are pregnant
- •Participants with inadequate renal, liver, or pulmonary functions
研究组 & 干预措施
Stratum 1
Stratum 1 (AML in complete remission)
Cyclophosphamide 60 mg/kg IV Day -7 Fludarabine 25 mg/m2/day IV Days -6 through -2 Donor pheresis Day -1 Start IL-2 on Day -1, then 3 times per week x 2 weeks NK Cell purification and infusion on Day 0
干预措施: Cyclophosphamide, Fludarabine, Clofarabine, Etoposide, Interleukin-2 (Drug)
Stratum 1
Stratum 1 (AML in complete remission)
Cyclophosphamide 60 mg/kg IV Day -7 Fludarabine 25 mg/m2/day IV Days -6 through -2 Donor pheresis Day -1 Start IL-2 on Day -1, then 3 times per week x 2 weeks NK Cell purification and infusion on Day 0
干预措施: Natural Killer Cell Infusion (Procedure)
Stratum 1
Stratum 1 (AML in complete remission)
Cyclophosphamide 60 mg/kg IV Day -7 Fludarabine 25 mg/m2/day IV Days -6 through -2 Donor pheresis Day -1 Start IL-2 on Day -1, then 3 times per week x 2 weeks NK Cell purification and infusion on Day 0
干预措施: CliniMACS System (Device)
Stratum 2
Stratum 2 (AML that is refractory or relapsed or AML with increasing minimal residual disease)
Clofarabine 40 mg/m2 IV, days -6 through -2 Etoposide 100 mg/m2 IV, days -6 through -2 Cyclophosphamide 400 mg/m2 IV, days -6 through 02 Donor pheresis Day -1 Start IL-2 Day -1, and then 3 times per week x 2 weeks NK Cell purification and infusion on Day 0.
干预措施: Cyclophosphamide, Fludarabine, Clofarabine, Etoposide, Interleukin-2 (Drug)
Stratum 2
Stratum 2 (AML that is refractory or relapsed or AML with increasing minimal residual disease)
Clofarabine 40 mg/m2 IV, days -6 through -2 Etoposide 100 mg/m2 IV, days -6 through -2 Cyclophosphamide 400 mg/m2 IV, days -6 through 02 Donor pheresis Day -1 Start IL-2 Day -1, and then 3 times per week x 2 weeks NK Cell purification and infusion on Day 0.
干预措施: Natural Killer Cell Infusion (Procedure)
Stratum 2
Stratum 2 (AML that is refractory or relapsed or AML with increasing minimal residual disease)
Clofarabine 40 mg/m2 IV, days -6 through -2 Etoposide 100 mg/m2 IV, days -6 through -2 Cyclophosphamide 400 mg/m2 IV, days -6 through 02 Donor pheresis Day -1 Start IL-2 Day -1, and then 3 times per week x 2 weeks NK Cell purification and infusion on Day 0.
干预措施: CliniMACS System (Device)
结局指标
主要结局
Number of Patients Experiencing Grade 3 or 4 Toxicities During Conditioning and up to 100 Days Post-transplant
时间窗: Beginning at on therapy through 100 days post-transplant
Document the number of patients experiencing grade 3 or 4 toxicities during conditioning and up to 100 days post-transplant. Toxicities were identified using Common Toxicity Criteria V 3.0 criteria.
Proportion of Patients Experiencing Grade 3 or 4 Toxicities During Conditioning and up to 100 Days Post-transplant
时间窗: Beginning at on therapy through 100 days post-transplant
Document the proportion of patients experiencing grade 3 or 4 toxicities during conditioning and up to 100 days post-transplant. Toxicities were identified using Common Toxicity Criteria V 3.0 criteria.
次要结局
- Duration of Engraftment of Natural Killer (NK) Cells(Measured at days 2, 7, 14, 21 and 28 after NK cell transplantation, and up to 189 days post transplant as clinically indicated)
- Percent of Peak NK Cell Chimerism(Days 2, 7, 14, 21 and 28 after NK cell transplantation)
- Percent of Detectable Donor NK Cells at Day 28(At 28 days)
- Day That Maximum NK Cell Engraftment Was Reached(Day 0 through Day 28 post NK cell transplantation)
- Number of KIR-mismatched NK Cells(Day 2 and day 14 post NK cell transplantation)
- Number of Participants With Evidence of NK Cells Lysing a Target Cell Line (K562)(Days 2, 7, 14, 21, and 28 after NK cell transplantation)
- Relapse-free Survival(Up to 2 years post NK cell transplantation)
- Overall Survival(Up to 2 years post NK cell transplantation)