Allogeneic Natural Killer Cells in Patients With Relapsed Acute Myelogenous Leukemia
试验速览
- 阶段
- 2 期
- 状态
- 已完成
- 入组人数
- 21
- 试验地点
- 1
- 主要终点
- Number of Patients With Natural Killer (NK) Cell Expansion
研究概览
简要总结
RATIONALE: Giving chemotherapy before a donor peripheral blood stem cell transplant helps stop the growth of cancer cells. It also helps stop the patient's immune system from rejecting the donor's stem cells. When the healthy stem cells and natural killer (NK) 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.
PURPOSE: This clinical trial is studying how well a peripheral stem cell transplant using NK cells from a donor works in treating patients with relapsed acute myeloid leukemia.
详细描述
OBJECTIVES:
Primary
- Evaluate the in vivo expansion of natural killer (NK) cells 14 days after treatment with allogeneic NK cell-enriched peripheral blood stem cell transplantation in patients with relapsed acute myeloid leukemia.
Secondary
- Determine the response rate, in terms of complete remission, in patients treated with this regimen.
- Correlate complete remission rate with NK cell expansion, interleukin-15 levels, and donor/recipient killer immunoglobulin receptor (KIR) ligand matching status in patients treated with this regimen.
- Determine the overall and progression-free survival of patients treated with this regimen.
- Determine the toxicity of this regimen in these patients.
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
- 2 Years 至 —（Child, Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Diagnosis of acute myeloid leukemia (AML) meeting 1 of the following criteria:
- •Primary refractory disease (no complete response [CR] after ≥ 2 induction therapies)
- •Relapsed disease not in CR after ≥ 1 course of standard reinduction therapy
- •Secondary AML from myelodysplastic syndromes
- •Disease relapsed ≥ 2 months after transplant and no option of donor lymphocyte infusions (e.g., recipients of autologous or umbilical cord blood transplants)
- •Chronic myelogenous leukemia with myeloid blast crisis not in second chronic phase after at least one cycle of standard chemotherapy and imatinib
- •Over 60 years of age with relapse within 6 months after completion of last chemotherapy
- •Over 60 years of age with blast count < 30% within 10 days before study entry
- •Related HLA-haploidentical natural killer cell donor available
- •No severe organ damage (by clinical or laboratory assessment)
- •Performance status 50-100%
- •No evidence of active infection on chest X-ray
- •No active fungal infection
排除标准
- •Active central nervous system (CNS) leukemia
- •Pleural effusions large enough to be detectable by chest x-ray
- •Pregnant or nursing (positive pregnancy test)
- •Fertile patients must use effective contraception
- •Less than 60 days since prior transplant
- •Less than 3 days since prior prednisone
- •Less than 3 days since other prior immunosuppressive medication
研究组 & 干预措施
Intent-to-Treat
All patients treated with natural killer (NK) cells (at a dose of 1.5-8 x 10^7/kg.)
干预措施: aldesleukin (Biological)
Intent-to-Treat
All patients treated with natural killer (NK) cells (at a dose of 1.5-8 x 10^7/kg.)
干预措施: therapeutic allogeneic lymphocytes (Biological)
Intent-to-Treat
All patients treated with natural killer (NK) cells (at a dose of 1.5-8 x 10^7/kg.)
干预措施: cyclophosphamide (Drug)
Intent-to-Treat
All patients treated with natural killer (NK) cells (at a dose of 1.5-8 x 10^7/kg.)
干预措施: fludarabine phosphate (Drug)
Intent-to-Treat
All patients treated with natural killer (NK) cells (at a dose of 1.5-8 x 10^7/kg.)
干预措施: in vitro treated peripheral blood stem cell transplantation (Procedure)
结局指标
主要结局
Number of Patients With Natural Killer (NK) Cell Expansion
时间窗: Study Day 14
Evaluation of expansion of donor allogeneic natural killer (NK) cells at day 14 following infusion (\>100 donor-derived NK cells per uL of patient blood detectable at day +14).
次要结局
- Overall Survival Time of Patients With Complete Remission(From Day 1 of Treatment until death or patient received bone marrow transplant.)
- Number of Patients With Complete Remission and Natural Killer Cell Expansion(Day 14)
- Number of Patients With Complete Remission(Day 28-35)
- Median Time to Disease Relapse (Months)(From 1st Day of treatment until death or receipt of bone marrow transplant.)