Adjonction of Androgenotheapy for Post-Remission Treatment of Elderly Patients With Acute Myeloid Leukemia - Results of the Multicenter Goelams SA-2002 Trial.
试验速览
- 阶段
- 3 期
- 状态
- 已完成
- 发起方
- 入组人数
- 330
- 试验地点
- 1
- 主要终点
- The primary objective of this study was to assess the ability of androgens to increase DFS.
研究概览
简要总结
A multicenter randomized trial evaluating the possible benefit of androgens during post remission therapy in an attempt to improve the outcome of AML in older patients.All patients received the ICL regimen as induction and were randomized to receive, after achieving CR or PR, a maintenance therapy including or not androgens. Patients randomized with androgens additionally received 10 to 20 mg according to body weigh of norethandrolone daily for up to 2 years
详细描述
-
Induction Therapy:
-
Idarubicin, 8mg/m2 d1-5; Cytarabine, 100mg/m2 d1-7 and Lomustine, 200mg/m d1
-
if CR or PR: randomisation = maintenance therapy including or not androgens
-
Maintenance therapy :
-
6 courses of reinduction with idarubicin (8mg/m2 d1) and cytarabine (100mg/m2d1-5, subcutaneously) every 3 months, and, between these courses, a continuous regimen of methotrexate and 6-mercaptopurine.
-
Patients randomized with androgens additionally received 10 to 20 mg according to body weigh of norethandrolone daily for up to 2 years
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 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
- •Patients aged 60 years or more
- •"de novo" AML according to FAB criteria
- •AML with 20% or more myeloid marrow blasts
- •signed and dated informed consent
- •OMS score < 3
- •Life expectancy > 1 month
排除标准
- •Patients aged < 60 years
- •or AML M3
- •or not classificated according to FAB criteria
- •or extramedular localisation of AML
- •OMS score ≥ 3
- •clinical Abnormal Cardiac fonction or with left ejection fraction < 40 %
- •abnormal renal function with creatinine clearance < 50/ml/mn/m²
- •abnormal hepatic function
- •previous cerebral stroke
- •previous malignancy : prostate, breast cancer (males)
- •PSA dosage > 4
- •Any coexisting medical or psychological condition that would pleclude participation in the required study procedures
研究组 & 干预措施
B
- Induction therapy Idarubicin, 8mg/m2 d1-5; Cytarabine, 100mg/m2 d1-7 and Lomustine, 200mg/m d1) If CR ou PR
- maintenance therapy every 3 months = 6 courses of reinduction with :
-idarubicin (8mg/m2 d1),cytarabine (100mg/m2d1-5 ), subcutaneously
- between the courses, a continuous regimen of methotrexate and 6-mercaptopurine.
干预措施: chemotherapy treatment (see arms) (Drug)
A
-
Induction therapy Idarubicin, 8mg/m2 d1-5; Cytarabine, 100mg/m2 d1-7 and Lomustine, 200mg/m d1) If CR ou PR
-
maintenance therapy every 3 months = 6 courses of reinduction with :
-
idarubicin (8mg/m2 d1),cytarabine (100mg/m2d1-5, subcutaneously)
-
10 to 20 mg (according to body weigh) of norethandrolone daily
-
between the courses, a continuous regimen of methotrexate and 6-mercaptopurine.
干预措施: chemotherapy treatment (see arm) + norethandrolone (Drug)
结局指标
主要结局
The primary objective of this study was to assess the ability of androgens to increase DFS.
时间窗: 3 years
次要结局
- The secondary objective was to improved EFS and OS and to assess side effects and toxicity of androgenotherapy(3 years)