A Phase I Study Investigating the Combination of RAD001 With Standard Induction and Consolidation Therapy in Older Patients With Newly Diagnosed Acute Myeloid Leukemia (AML)
试验速览
- 阶段
- 1 期
- 状态
- 已完成
- 入组人数
- 11
- 试验地点
- 5
- 主要终点
- Maximum-tolerated dose of everolimus
研究概览
简要总结
RATIONALE: Drugs used in chemotherapy, such as mitoxantrone hydrochloride, cytarabine, etoposide, and idarubicin, work in different ways to stop the growth of cancer cells, either by killing the cells or by stopping them from dividing. Everolimus may stop the growth of cancer cells by blocking some of the enzymes needed for cell growth and by blocking blood flow to the cancer. Giving everolimus together with combination chemotherapy may kill more cancer cells.
PURPOSE: This phase I trial is studying the side effects and best dose of everolimus when given together with mitoxantrone hydrochloride, cytarabine, etoposide, and idarubicin in treating older patients with newly diagnosed acute myeloid leukemia.
详细描述
OBJECTIVES:
Primary
- To determine the maximum-tolerated dose of everolimus in combination with standard remission-induction therapy comprising mitoxantrone hydrochloride, cytarabine, and etoposide (MICE-regimen) followed by consolidation therapy comprising idarubicin, cytarabine, and etoposide in older patients with newly diagnosed acute myeloid leukemia.
Secondary
- To determine the safety profile of this regimen in these patients.
- To determine the anti-leukemic activity (complete remission rate [complete remission and complete remission with incomplete blood count recovery]) following one or two induction courses.
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
- 61 Years 至 75 Years（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
Everolimus
Everolimus mice-regimen
干预措施: cytarabine (Drug)
Everolimus
Everolimus mice-regimen
干预措施: etoposide (Drug)
Everolimus
Everolimus mice-regimen
干预措施: everolimus (Drug)
Everolimus
Everolimus mice-regimen
干预措施: idarubicin (Drug)
Everolimus
Everolimus mice-regimen
干预措施: mitoxantrone hydrochloride (Drug)
结局指标
主要结局
Maximum-tolerated dose of everolimus
时间窗: At one year from study entry
MTD of RAD given in combination with the MICE regimen
次要结局
- Safety(At one year from study entry)
- Complete remission rate(At one year from study entry)