NCT02395822已完成2 期
MT2014-25: Haploidentical Donor Natural Killer (NK) Cell Infusion With Subcutaneous Recombinant Human IL-15 (rhIL-15) in Adults With Refractory or Relapsed Acute Myelogenous Leukemia (AML)
适应症
干预措施
试验速览
- 阶段
- 2 期
- 状态
- 已完成
- 入组人数
- 17
- 试验地点
- 1
- 主要终点
- < 5% Marrow Blast, no Circulating Peripheral Blasts and Neutrophil Count of > 1 x 10^9/L
研究概览
简要总结
A phase II trial of CD3/CD19 depleted, IL-15 activated, donor natural killer (NK) cells in adults and subcutaneous IL-15 given after a preparative regimen for the treatment of relapsed or refractory acute myelogenous leukemia (AML). The primary objective is to study the potential efficacy of NK cells and IL-15 to achieve complete remission while maintaining safety.
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
- 18 Years 至 70 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •(Recipient):
- •Meets ONE of the following disease criteria:
- •Primary AML induction failure: no CR after 2 or more induction attempts
- •Relapsed AML or Secondary AML (from MDS or treatment related): not in CR after 1 or more cycles of standard re-induction therapy
- •AML relapsed > 2 months after transplant: No re-induction required, and no more than 1 re-induction cycle is allowed.
- •Relapsed AML for patients > 60 years of age the 1 cycle of standard chemotherapy is not required if either of the following criteria is met:
- •Relapse within 6 months of last chemotherapy
- •BM blast count < 30% within 10 days of starting protocol therapy
- •Available related HLA-haploidentical donor (aged 14 to 75 years) by at least Class I serologic typing at the A&B locus
- •Karnofsky Performance Status ≥ 60%
- •Patients must have adequate organ within 14 days (28 days for pulmonary and cardiac) of study registration
- •Able to be off prednisone or other immunosuppressive medications for at least 3 days prior to NK cell infusion (excluding preparative regimen pre-medications).
- •Agrees to use contraception prior to study entry and for the duration of study participation.
排除标准
- •(Recipient):
- •Bi-phenotypic acute leukemia.
- •Transplant < 60 days prior to study enrollment.
- •Active autoimmune disease.
- •History of severe asthma
- •Uncontrolled intercurrent illness
- •New or progressive pulmonary infiltrates on screening chest x-ray or chest CT scan that has not been evaluated with bronchoscopy
- •Pleural effusion large enough to be detectable on chest x-ray.
- •Pregnant women
- •History of HIV, active or chronic hepatitis B, hepatitis C or HTLV-I infection
- •Known hypersensitivity to any of the study agents used
- •Received investigational drugs within the 14 days of study registration.
- •Known active CNS involvement.
- •Criteria For Initial Donor Selection:
- •Related donors (sibling, parent, offspring, parent or offspring of an HLA identical sibling).
- •14-75 years of age.
- •At least 40 kilogram body weight.
- •In general good health as determined by the evaluating medical provider.
- •HLA-haploidentical donor/recipient match by at least Class I serologic typing at the A&B locus.
- •Not pregnant.
- •Able and willing to undergo apheresis.
研究组 & 干预措施
Preparative Regimen and SubQ rHuIL-15
Experimental
Preparative Regimen of Fludarabine and Cyclophosphamide
IL-15 Activation of Donor NK Cells:
IL-15 to Facilitate NK Cell Survival and Expansion
干预措施: IL-15 (Biological)
结局指标
主要结局
< 5% Marrow Blast, no Circulating Peripheral Blasts and Neutrophil Count of > 1 x 10^9/L
时间窗: Day 42 post NK cell infusion
Without platelet recovery
次要结局
- In Vivo Expansion (>100) of NK Cells (Defined at CD56+/CD3- Lymphocytes)(Day 14 post NK cell infusion)
- Proportion of Patients Experiencing Grade, 3, 4, and 5 Toxicities (Assessed by CTCAE v. 4)(Days 1-5 and Days 8-12, 24 hours after the last IL-15 dose, Day +28, Day +42)
- Treatment Related Mortality(6 months post-therapy)
- Number of Subjects Achieving Complete Response, Defined as in Vivo Donor Derived NK Cell Expansion of > 100 Donor Derived NK Cells.(Day 42 post NK cell infusion)
研究者
研究点 (1)
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