NCT02483312进行中（未招募）1 期
Phase I Study of Autologous Acute Myelogenous Leukemia (AML) Cells Containing Lentivirus Engineering Expression of IL-12
适应症
干预措施
试验速览
- 阶段
- 1 期
- 状态
- 进行中（未招募）
- 入组人数
- 9
- 试验地点
- 1
- 主要终点
- Number of side effects by type and severity
研究概览
简要总结
This is a phase 1 study (the first stage in testing a new treatment to see how safe and tolerable the treatment is) which will include patients with acute myeloid leukemia (AML) that has either returned or has a more than a 70% chance of coming back and cannot have a bone marrow transplant.
This study will see whether modifying a patient's AML cells to produce IL-12 and giving it back to the patient is safe and useful in patients with AML that cannot have bone marrow transplants.
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 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Patient with AML and >=18 years of age.
- •Agrees to participate in the study and signs the informed consent
- •Viable cells are available for successful modification
- •First or higher complete remission and have high risk features of relapse.
- •Patients who have received prior treatment and are not in remission must have stable white blood cell count and are not receiving any chemotherapy or desiring further intensive treatment.
- •Less than 10% blast cells in the bone marrow following induction or re-induction therapy and not desiring further intensive treatment.
- •Acceptable creatinine, Aspartate transaminase (AST), Alkaline phosphatase (ALP), bilirubin lab results.
- •Agree to use contraception
- •Not pregnant
- •Able to comply with study procedures
排除标准
- •Eastern Cooperative Oncology Group (ECOG) performance status >2
- •Known persistent infection
- •Known central nervous system (CNS) disease
- •Greater than 10% blasts in the bone marrow or circulating blast cells
- •Life expectancy < 2 months
- •Receiving any chemotherapy, corticosteroids, Cox2 inhibitors or any non-drug therapies with the intent of altering the immune response or kill leukemic cells within one week prior to infusion of IL-12, except azacytidine.
- •Patients who are HIV positive.
研究组 & 干预措施
IL-12
Experimental
A single dose of IL-12, given intravenously.
干预措施: IL-12 (Biological)
结局指标
主要结局
Number of side effects by type and severity
时间窗: 2 years
次要结局
- Length of time patient is alive(2 years)
- Levels of acute myeloid leukemia (AML)(Day 28 to 2 years)
- Levels of IL-12(Day 28 to 2 years)
研究者
研究点 (1)
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