Non-intensive But Non-interruptive Treatment of Adult Ph-negative Acute Lymphoblastic Leukemia With Randomization for Maintenance or Autologous Hematopoietic Stem Cell Transplantation (HSCT) Followed by Maintenance in T-cell ALL Patients
试验速览
- 阶段
- 不适用
- 入组人数
- 350
- 试验地点
- 2
- 主要终点
- Disease-free survival
研究概览
简要总结
No high-dose methotrexate (MTX) and high-dose cytarabine (ARA-C) consolidation blocks, L-asparaginaseis scheduled for 1 year of treatment, 21 intrathecal injections through the whole treament, T-ALL patients in complete remossion (CR) after the informed consent are randomized to: auto-HSCT vs no auto-HSCT, - with the similar further maintenance. Stem cell harvest is performed after the 3rd consolidation by G-SCF disregarding minimal residual disease (MRD) level. Auto-HSCT is planned after the 5th consolidation phase. All primary bone samples are collected and tested for cytogenetics and molecular markers, all included patients are monitored by flow cytometry by aberrant immunophenotype in a centralized lab.
详细描述
- 7 days prednisolone prephase
- 8 weeks induction with de-escalation of induction chemotherapy: 3 instead of 4 dauno/vncr pulses,
- instead of 2 Cph injections during induction,
- instead of 4 ARA-C blocks, distribution of of L-asp injections through all phases
- After CR achievement T-cell ALL patients are being randomized to auto-HSCT vs no auto-HSCT
- Non-interruptive 5 consolidation phases with dose modification according to WBC and platelets count after CR achievement. Rotation of consolidation is permitted
- After the 3rd consolidation stem cells harvesting is carried out for T-cell ALL patients randomized to auto-HSCT
- Auto-HSCT after the 5th consolidation phase with non-myeloablative CEAM conditioning
- 2 years maintenance for all patients
- 21 TIT through the whole treatment with higher intensity during induction|consolidation
- Centralized MRD monitoring at +70 d, + 133 d, + 190 days; before and after auto-HSCT
- Allo-HSCT is planned only for very high risk patients (11q23 ALL, MRD positivity at day +190)
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Factorial
- 主要目的
- Treatment
- 盲法
- Single (Investigator)
入排标准
- 年龄范围
- 18 Years 至 55 Years（Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •age 18-55 yy, newly diagnosed non-treated Ph-negative ALL
排除标准
- •age > 55 yy, Ph-positivity, relapsed|refractory ALL, pretreated ALL
研究组 & 干预措施
no Auto-HSCT
After completing prolonged consolidation T-cell ALL patients will continue with 2 years maintenance
Auto-HSCT
After completing prolonged consolidation T-cell ALL patients will get autologous HSCT followed by 2 years maintenance
干预措施: Autologous HSCT (Procedure)
结局指标
主要结局
Disease-free survival
时间窗: 5-years
Impact of autologous HSCT on DFS in T-cell ALL patients
次要结局
- MRD-negativity after consolidation(6 months)
- Overall survival(5-years)