NCT00526305已完成4 期
LAL-Ph-2000: Treatment of Acute Lymphoblastic Leukemia Chromosome Philadelphia Positive
PETHEMA Foundation56 个研究点 分布在 1 个国家目标入组 100 人开始时间: 2000年1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
- 100
- 试验地点
- 56
- 主要终点
- To evaluate the efficacy of treatment in order to response rate, relapse free survival and overall survival
研究概览
简要总结
Due to ALL Ph+ patients should receive a different treatment, is proposed a therapeutical protocol with: intensification treatment of induction to increment the CR rate, allogenic transplantation in first CR, autologous transplantation follow by alfa interferon in patients cannot done allogenic transplantation.
详细描述
Remission Induction:
- Vincristine (VCR): 1,5 mg/m2 i.v., days 1 and 8
- Daunorubicin (DNR): 60 mg/m2 i.v., days 1 and 8.
- Prednisone (PDN): 60 mg/m2/day, i.v. or p.o., days 1 to 14
- L-asparaginase (L-ASA): 10.000 UI/m2, i.v.days 5-7 and 11-13
Results:
1. Standard response: The induction treatment will be completed with the same drugs, changing L-ASA to ARA-C, during two more weeks
2 Slow response. Chemotherapy with mitoxantrone and high dose ARA-C
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 65 Years（Child, Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •ALL BCR/ABL+ patients Age < 65 years No previous treatment
排除标准
- •Other LLA variability
- •Previous history of coronary valvular, hypertensive cardiopathy illness
- •Chronic hepatic illness
- •Chronic respiratory insufficiency
- •Renal insufficiency not caused by LLA
- •Severe neurological problems not caused by LLA
- •Severe affection of the performance status (grade 3-4 OMS gradation) not caused by LLA
结局指标
主要结局
To evaluate the efficacy of treatment in order to response rate, relapse free survival and overall survival
时间窗: 5 years
次要结局
未报告次要终点
研究者
研究点 (56)
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