NCT00526409已完成4 期
LAL-AR-N-2005: Study Treatment for Children High Risk Acute Lymphoblastic Leukemia
PETHEMA Foundation4 个研究点 分布在 1 个国家目标入组 40 人开始时间: 2005年6月1日最近更新:
适应症
相关药物
试验速览
- 阶段
- 4 期
- 状态
- 已完成
- 发起方
- 入组人数
- 40
- 试验地点
- 4
- 主要终点
- To improve the global results obtained in PETHEMA LAL-AR-93 study in terms of events free time
研究概览
简要总结
The study objective is to improve the global results obtained with LAL-AR-93 study, reaching an event free survival between 60-70%.
Identify patients with bad prognosis, with minimal residual disease,who can benefit of allogenic bone marrow transplantation
详细描述
INDUCTION TREATMENT
Systemic chemotherapy:
PREDNISOLONE 60 mg/m2 /day, oral or i.v. x 21 days (1 to 22) 30 mg/m2 /day, oral or i.v. x 7 days (23 to 29)
DAUNORUBICIN 30 mg/m2 , i.v. days 1,8,15 and 22
VINCRISTINE 1,5 mg/m2, i.v. days 1,8,15 and 22
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
- — 至 16 Years（Child）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •High risk children with acute lymphoblastic leukemia
排除标准
- •Mature B-ALL (FABL3)
- •Mixed forms of ALL
- •Patients with coronary disorders, valvular or hypertensive cardiopathy
- •Patients with chronic liver disorders
- •Chronic pulmonary disorders
- •Renal insufficiency
- •Neurologic disfunctions
- •ECOG 3 and 4
结局指标
主要结局
To improve the global results obtained in PETHEMA LAL-AR-93 study in terms of events free time
时间窗: 2 years
次要结局
未报告次要终点
研究者
研究点 (4)
Loading locations...
相似试验
Unknown
4 期
Malaysia-Singapore Acute Lymphoblastic Leukemia 2010 StudyAcute Lymphoblastic Leukemia (ALL)NCT02894645National University Hospital, Singapore500
招募中
2 期
International Study for Treatment of High Risk Childhood Relapsed ALL 2010Acute Lymphoblastic Leukemia (ALL)NCT03590171Charite University, Berlin, Germany250
已完成
3 期
International Study for Treatment of Standard Risk Childhood Relapsed ALL 2010Acute Lymphoblastic Leukemia (ALL)NCT01802814Charite University, Berlin, Germany700
招募中
不适用
The Pediatric ALL Evaluation and TrialACL InjuryACL TearNCT04825587Ann & Robert H Lurie Children's Hospital of Chicago240
已完成
3 期
NOPHO-AML 2004 Study for Children With Acute Myeloid LeukemiaAcute Myeloid LeukemiaNCT00476541University of Aarhus250