A Phase 2 Study of Imatinib Mesylate (Gleevec) as Maintenance Therapy After Induction and Consolidation Chemotherapy in Patients With Newly Diagnosed C-kit Positive Acute Myeloid Leukemia
试验速览
- 阶段
- 2 期
- 状态
- 已完成
- 入组人数
- 32
- 试验地点
- 4
- 主要终点
- Median Progression-free Survival (PFS) for Patients Less Than 60 Years of Age
研究概览
简要总结
RATIONALE: Imatinib mesylate may stop the growth of cancer cells by blocking some of the enzymes needed for cell growth.
PURPOSE: This phase II trial is studying how well imatinib mesylate works in treating patients with newly diagnosed acute myeloid leukemia who have received chemotherapy.
详细描述
OBJECTIVES:
Primary
- To determine whether adding imatinib mesylate as maintenance therapy improves progression-free survival in patients with c-kit positive acute myeloid leukemia (AML) compared with historical controls.
Secondary
- To assess the feasibility of administering imatinib mesylate as maintenance therapy after the completion of induction and consolidation therapy in these patients.
- To evaluate potential mechanisms of relapse/resistance in c-kit positive AML by examining multidrug resistance gene expression and AF1q gene expression and to determine whether these levels correlate with c-kit expression.
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
- 未提供
排除标准
- 未提供
研究组 & 干预措施
Imatinib Mesylate
干预措施: imatinib mesylate (Drug)
Imatinib Mesylate
干预措施: gene expression analysis (Genetic)
Imatinib Mesylate
干预措施: mutation analysis (Genetic)
Imatinib Mesylate
干预措施: polymerase chain reaction (Genetic)
Imatinib Mesylate
干预措施: flow cytometry (Other)
Imatinib Mesylate
干预措施: biopsy (Procedure)
结局指标
主要结局
Median Progression-free Survival (PFS) for Patients Less Than 60 Years of Age
时间窗: up to 5 years from the End of Treatment
PFS measured from the date of Complete Response (CR) to the date of relapse or death. Progression defined as any of the following event: progression to accelerated phase or blast crisis, death, loss of CHR or MCyR, or in patients not achieving a CHR an increasing WBC despite appropriate therapeutic management This outcome will be reported as median progression-free survival in months for participants less than 60 years of age.
Percent of Participants 60 Years of Age or Older With PFS at 8 and 13 Months Post-treatment
时间窗: at 8 and 13 months after treatment.
Percent of participants 60 years of age or older with PFS at 8 and 13 months post-treatment
Progression-free Survival for Patients 60 Years of Age and Older
时间窗: up to 5 years from the End of Treatment
Progression free survival will be measured from the date of Complete Response (CR) to the date of relapse or death.
Percent of Participants Less Than 60 Years of Age With PFS at 8 and 13 Months Post-treatment
时间窗: at 8 and 13 months after treatment.
Percent of participants less than 60 years of age with PFS at 8 and 13 months post-treatment
次要结局
- Toxicity as Measured by NCI CTC v. 3.0(13 months from start of treatment)