Comparison of Efficacy of Allogenic Bone Marrow Transplantation With Cytoreduction and Chemotherapy in ALL Patients
试验速览
- 阶段
- 2 期
- 状态
- 已完成
- 入组人数
- 30
- 试验地点
- 2
- 主要终点
- Efficacy of allogenic BMT compare with cytoreduction and chemotherapy in ALL patient
研究概览
简要总结
Patients with newly diagnosed Acute lymphoblastic leukemia after providing consent, will be screened for eligibility. Eligible patients will be treated with Vincristine (1 mg/m2 at Day 1 and Day 8), Dexamethasone 24 mg/d day 1-15 and IT at Days 1, 4, 8 and 12. At day 14 patients will be randomized in two group. BMT group who have donor and Chemotherapy group who don't have suitable donor. BMT group treated with allogenic Bone Marrow Transplantation and Chemotherapy treated with Cyclophosphamide at day 15, Daunorubicin at day 15-18, Vincristine at day 15 and 22 and Dexamethasone at day 12-28 followed by standard chemotherapy. In BMT group patients will be received CNS radiotherapy at +100 day after transplantation.
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
- 16 Years 至 50 Years（Child, Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Diagnose of Acute lymphoblastic leukemia
- •Age between 16 to 50 year
- •New case of ALL
排除标准
- •Primary CNS involvement
- •Primary Testis involvement
- •Previously treated
结局指标
主要结局
Efficacy of allogenic BMT compare with cytoreduction and chemotherapy in ALL patient
时间窗: 1 year
次要结局
- Overall Survival after BMT compare with chemotherapy.(1 year)
- Disease Free Survival after BMT compare with chemotherapy(1 year)