GIMEMA LAL 0496: High-dose Anthracycline in the Induction Regimen for the Treatment of Adult Acute Lymphoblastic Leukemia. A Prospective Multicentric GIMEMA Trial.
试验速览
- 阶段
- 2 期
- 主要终点
- Number of patients with complete response
研究概览
简要总结
The present study aims at verifying the state of the art in what this illness concerns and at organizing a centralized samples analysis.
详细描述
The present trial is a prospective multicentric GIMEMA study, in which adult ALL patients are extensively analyzed at diagnosis by a multiparametric approach including CC and molecular analysis for the following gene rearrangements: BCR-ABL, MLL-AF4, E2A-PBX1, TEL-AML1, MLL, p15 and p16 deletion in order to give place to a carefully characterization of the genetic lesions occurring in adult ALL and to evaluate their prognostic significance in a large cohort of patients homogeneously treated.
This study requires a central handling and analysis of bone marrow (BM) or peripheral blood samples at presentation.
研究设计
- 研究类型
- Interventional
- 分配方式
- Na
- 干预模型
- Single Group
- 主要目的
- Treatment
- 盲法
- None
入排标准
- 年龄范围
- 16 Years 至 60 Years（Child, Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Patients aged 16-60
- •Diagnosed with previously untreated T-ALL and B-ALL
排除标准
- •previously treated ALL patients
研究组 & 干预措施
High-dose anthracycline
干预措施: High-dose anthracycline (Drug)
结局指标
主要结局
Number of patients with complete response
Patients are followed-up for response till death
次要结局
- Number of patients that reach disease-free-survival