NCT01289678终止2 期
Phase II Trial of Daily Pulse Interleukin-2 With Famotidine in Acute Myelogenous Leukemia
Leo W. Jenkins Cancer Center1 个研究点 分布在 1 个国家目标入组 18 人开始时间: 2006年7月最近更新:
适应症
干预措施
相关药物
试验速览
- 阶段
- 2 期
- 状态
- 终止
- 发起方
- 入组人数
- 18
- 试验地点
- 1
- 主要终点
- Event-free Survival
研究概览
简要总结
Assess the immunotherapy benefit of interleukin-2 in acute myelogenous leukemia treatment during lymphocyte recovery.
详细描述
Upon lymphocyte recovery after myeloablative induction standard chemotherapy pulse Interleukin-2 administered
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
- •Confirmed hematopathology diagnosis of AML receiving marrow suppressive treatment
- •Total WBC recovery of 500 mm3 prior to IL-2 treatment
- •Platelet count of at least 20,000 mm3 prior to starting IL-2 treatment
- •Active infection controlled prior to starting IL-2 treatment
- •Stable systolic blood pressure > 90mm Hg prior to starting IL-2 treatment
- •O2 saturation >90% prior to starting treatment
- •Stable cardiopulmonary status prior to starting IL-2 treatment
- •Serum creatinine < or equal to 2.0 mg/dl
- •Total bilirubin and AST <3x upper limits normal
排除标准
- •Acute Promyelocytic Leukemia
- •Active thrombocytopenic bleeding
- •Cardiac ejection fraction below 45%
- •Pregnancy and/or lactation
研究组 & 干预措施
interleukin-2
Experimental
interleukin-2 therapy during lymphocyte recovery
干预措施: Interleukin-2 (Drug)
结局指标
主要结局
Event-free Survival
时间窗: 3 years
Event-free survival (EFS) = all patients; measured from the date of entry onto study until treatment failure, AML relapse, or death
次要结局
未报告次要终点
研究者
研究点 (1)
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