A Pilot Study of Nuclear Factor-kappa B (NFkB) Inhibition During Induction Chemotherapy for Patients With Acute Myelogenous Leukemia (AML)
试验速览
- 阶段
- 1 期
- 状态
- 终止
- 入组人数
- 15
- 试验地点
- 1
- 主要终点
- Temporal changes in leukemic cell NF-kB activity
研究概览
简要总结
RATIONALE: Studying samples of blood from patients with cancer in the laboratory may help doctors learn more about changes that occur in cancer cells. It may also help doctors understand how cancer cells respond to treatment with choline magnesium trisalicylate.
PURPOSE: This pilot clinical trial is studying gene expression in cancer cells during chemotherapy and the safety of choline magnesium trisalicylate in treating patients with newly diagnosed acute myeloid leukemia.
详细描述
OBJECTIVES:
Primary
- Determine temporal changes in leukemic cell NF-kB activity when choline magnesium trisalicylate is administered during induction chemotherapy in patients with newly diagnosed acute myeloid leukemia.
- Determine toxicities of this regimen in these patients.
Secondary
- Determine patterns of leukemic cell gene expression in patients treated with this regimen.
- Determine if NF-kB modulation results in enhanced apoptosis in patients treated with this regimen.
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
- 18 Years 至 —（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
Dexamethasone plus Choline Magnesium Trisalicylate
Dexamethasone plus Choline Magnesium Trisalicylate
干预措施: choline magnesium trisalicylate (Drug)
Dexamethasone plus Choline Magnesium Trisalicylate
Dexamethasone plus Choline Magnesium Trisalicylate
干预措施: Dexamethasone (Drug)
Choline Magnesium Trisalicylate
Choline Magnesium Trisalicylate
干预措施: choline magnesium trisalicylate (Drug)
结局指标
主要结局
Temporal changes in leukemic cell NF-kB activity
时间窗: 5 years
次要结局
- Apoptosis related to NF-kB modulation(5 years)
- Patterns of leukemic cell gene expression after administration of choline magnesium trisalicylate(5 years)