A Phase II Study of CLAG Regimen in Combination With Imatinib Mesylate (Gleevec) in Refractory or Relapsed Acute Myeloid Leukemia
试验速览
- 阶段
- 2 期
- 状态
- 撤回
- 入组人数
- 20
- 试验地点
- 1
- 主要终点
- Establishing the overall response rate and the safety of combining imatinib mesylate with CLAG regimen
研究概览
简要总结
The purpose of this study is to evaluate the safety of combined chemotherapy treatment (CLAG regimen) with Imatinib Mesylate (Gleevec) in patients with AML.
详细描述
In relapsed or resistant acute myeloid leukemia (type of blood cancer where immature blood cells are increased, blocking normal blood cells production) no standard therapy exits. Response rates are similar for different chemotherapy treatments. Allogenic stem cell transplant remains the only curative option
The purpose of this study is to evaluate the safety of combined chemotherapy treatment (CLAG regimen) with Imatinib Mesylate (Gleevec). The CLAG regimen is a combination of the chemotherapy drugs cladribine and cytarabine, as well as, neupogen which increases the white blood counts.
Imatinib Mesylate is believed to work by interfering with the abnormal protein by blocking it from telling the body to keep making more and more abnormal white blood cells. Imatinib Mesylate is approved by the FDA for the treatment of chronic myeloid leukemia (CML) and some types of acute lymphoblastic leukemia (ALL). Its use in combination with CLAG regimen is considered experimental for the treatment of Acute Myeloid Leukemia / CML blast crisis
The goal of the study is to find out what effects (good and bad) Imatinib Mesylate (Gleevec)combined with chemotherapy (CLAG regimen) on acute myeloid leukemia.
研究设计
- 研究类型
- Interventional
- 分配方式
- Non Randomized
- 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
- 未提供
排除标准
- 未提供
研究组 & 干预措施
Single Arm - treatment period
Drug Name/Days Administered
Neupogen/Days 1-6
CLAG/Days 2-6
Gleevec/Days 2-15
干预措施: Imatinib Mesylate (Drug)
Single Arm - treatment period
Drug Name/Days Administered
Neupogen/Days 1-6
CLAG/Days 2-6
Gleevec/Days 2-15
干预措施: CLAG (Drug)
结局指标
主要结局
Establishing the overall response rate and the safety of combining imatinib mesylate with CLAG regimen
时间窗: The amount of time it takes to enroll 20 pts. About 1 year
次要结局
- The sample size is calculated based on two stage Phase II clinical design. Ten patients will be accrued during stage 1 and 10 during stage 2).(1 year)
