NCT00775593已完成2 期
An Open Label Phase II Trial of Clofarabine and Temsirolimus in Older Patients With Relapsed or Refractory Acute Myeloid Leukemia (AML)
适应症
相关药物
试验速览
- 阶段
- 2 期
- 状态
- 已完成
- 入组人数
- 60
- 试验地点
- 19
- 主要终点
- Complete Response Rate
研究概览
简要总结
RATIONALE: Drugs used in chemotherapy, such as clofarabine, work in different ways to stop the growth of cancer cells, either by killing the cells or by stopping them from dividing. Temsirolimus may stop the growth of cancer cells by blocking some of the enzymes needed for cell growth. Giving clofarabine together with temsirolimus may kill more cancer cells.
PURPOSE: This phase II trial is studying how well giving clofarabine together with temsirolimus works in treating older patients with relapsed or refractory acute myeloid leukemia.
详细描述
OBJECTIVES:
Primary
- To determine the complete response rate in older patients with relapsed or refractory acute myeloid leukemia when treated with low-dose clofarabine and temsirolimus.
Secondary
- To determine the tolerability and safety of this regimen.
- To determine the duration of response.
- To determine the duration of survival.
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
- 60 Years 至 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •DISEASE CHARACTERISTICS:
- •Cytologically confirmed acute myeloid leukemia (AML) meeting the following criteria:
- •At least 20% of blasts in the bone marrow
- •AML in first relapse OR refractory to no more than one prior combination of intensive chemotherapy induction regimen
- •No acute promyelocytic leukemia
- •No blast transformation of chronic myeloid leukemia or other myeloproliferative disorders
- •No active CNS leukemia
- •PATIENT CHARACTERISTICS:
- •WHO performance status 0-2
- •Life expectancy ≥ 4 weeks
- •Serum total bilirubin ≤ 1.5 times upper limit of normal (ULN)*
- •AST and ALT ≤ 2.5 times ULN*
- •Serum creatinine ≤ 1.0 mg/dL* OR estimated glomerular filtration rate > 60 mL/min
- •No active uncontrolled systemic infection
- •No concurrent active malignancy
- •No HIV positivity
- •No severe concurrent medical condition or psychiatric disorder that would preclude study participation NOTE: *Unless due to organ leukemic involvement
- •PRIOR CONCURRENT THERAPY:
- •See Disease Characteristics
- •More than 2 weeks since prior myelosuppressive chemotherapy
- •At least 48 hours since prior hydroxyurea
- •No prior clofarabine or temsirolimus
- •No prior allogeneic stem cell transplantation
- •No investigational drug within the past 30 days
排除标准
- 未提供
结局指标
主要结局
Complete Response Rate
时间窗: At 2 years from study entry
次要结局
- Number of Serious Adverse Events Within 2 Years(At 2 years from study entry)
- Duration of Survival(At 2 years from study entry)
- Duration of Response(At 2 years from study entry)
研究者
研究点 (19)
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