PETHEMA LAL-RI/96: Treatment for Patients With Standard Risk Acute Lymphoblastic Leukemia
试验速览
- 阶段
- 4 期
- 状态
- 已完成
- 发起方
- 入组人数
- 374
- 试验地点
- 99
- 主要终点
- Efficacy of treatment in adults with standard risk acute lymphoblastic leukemia
研究概览
简要总结
The objective of current protocol is try improve the results of chemotherapy treatment in patients with ALL wich is not indicated the peripheral stem cell transplant in first remission, with an intensive consolidation follow by re-inductions.
详细描述
Induction therapy:
Patients with standard risk receive vincristine (1,5 mg/m2)IV on days 1, 8, 15 and 22;daunorubicin (30 mg/m2)IV on days 1, 8, 15 and 22; oral or IV prednisone 60 mg/m2/day, days 1 to 27 and 30 mg/m2/day, days 28 to 35;asparaginase 10.000 UI/m2 IM or IV, days 10 to 12, 17 to 19 and 24 to 26;cyclophosphamide (500 mg/m2)IV days 1, 2 and 29; methotrexate, cytosine arabinoside and hydrocortisone, days 1 to 22.
Patients older than 55 years are not treated with asparaginase and cyclophosphamide.
Consolidation therapy (1):
Standard risk: Mercaptopurine 50 mg/m2, PO, days 1 to 7, 28-35 and 56-63; methotrexate (3g/m2)IV/24 hours, day 1, 28 and 56; VM-26 (150 mg/m2)/12 hours, IV, days 14 and 42; ARA-C (500 mg/m2)/12 hours, IV days 14-15 and 42-43; intrathecally treatment, days 1, 28 and 56.
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
- 15 Years 至 —（Child, Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Adults (over 15 years) with ALL standard risk no prior antiblastic chemotherapy
排除标准
- •Mature B-ALL (FABL3) or with cytogenetic ALL "Burkitt-like" alterations (t[8;14], t[2;8], t[8;22])
- •Mixed forms of ALL
- •Acute Leukemia no differentiate
- •Patients with coronary disorders, valvular or hypertensive cardiopathy
- •Patients with chronic liver disorders
- •Chronic pulmonary disorders
- •Renal insufficiency
- •Neurologic disfunctions
- •ECOG 3 and 4
- •No signed consent form
结局指标
主要结局
Efficacy of treatment in adults with standard risk acute lymphoblastic leukemia
时间窗: 2 years
次要结局
- Demonstrate that in this group of patients, the CNS relapse is not frequently and is not necessary cranial radiotherapy(2 years)
- To evaluate the treatment tolerance(1 year)