NCT00151255已完成3 期
Phase III - Study on All-Trans Retinoic Acid in Combination With Standard Induction and Consolidation Therapy in Older Patients With Newly Diagnosed Acute Myeloid Leukemia
University of Ulm58 个研究点 分布在 2 个国家目标入组 500 人开始时间: 2004年6月1日最近更新:
适应症
相关药物
试验速览
- 阶段
- 3 期
- 状态
- 已完成
- 发起方
- 入组人数
- 500
- 试验地点
- 58
- 主要终点
- event-free survival
研究概览
简要总结
This is a study looking at all-trans retinoic acid in combination with standard induction and consolidation therapy in older patients with newly diagnosed acute myeloid leukemia (AML).
详细描述
First Induction Therapy:
-
Cytarabine 100 mg/m² cont. i.v. days 1-5
-
Idarubicin 12 mg/m² i.v. days 1, 3
-
ATRA 45 mg/m² p.o. days 4-6, ATRA 15 mg/m² p.o. days 7-28
Second Induction Therapy:
- Cytarabine 100 mg/m² cont. i.v. days 1-5
- Idarubicin 12 mg/m² i.v. days 1, 3
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
- 61 Years 至 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Newly diagnosed AML defined according to the World Health Organization (WHO) classification (excluding acute promyelocytic leukemia [APL])
- •Aged > 60 years
- •All patients have to be informed about the character of the study. Written informed consent of each patient at study entry.
- •Molecular and cytogenetical analyses on initial bone marrow and peripheral blood specimen have to be performed at the central reference laboratories.
排除标准
- •Bleeding independent of the AML
- •Acute promyelocytic leukemia
- •Uncontrolled infection
- •Participation in a concurrent clinical study
- •Insufficiency of the kidneys (creatinine > 1.5 x upper normal serum level), of the liver (bilirubin, AST or AP > 2 x upper normal serum level), severe obstruction or restrictive ventilation disorder, heart failure New York Heart Association [NYHA] III/IV
- •Severe neurological or psychiatric disorder interfering with ability of giving informed consent
- •No consent for the registration, storage and processing of data concerning the characteristics of the AML and the individual course
- •Performance status WHO > 2
结局指标
主要结局
event-free survival
时间窗: two years
次要结局
- overall survival(two years)
- kind, incidence, severity, temporal sequence and correlation of side effects of the study drugs(during therapy)
- cumulative incidence of relapse(two years)
- complete remission (CR) rate after induction therapy(after second induction cycle)
- cumulative incidence of death(two years)
研究者
Prof. Dr. Richard Schlenk
PD Dr.
University of Ulm
研究点 (58)
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