Multicenter Prospective Study of Safety and Efficacy MRD-associated Non-intensive But Non-interruptive Treatment of Ph-negative Acute Lymphoblastic Leukemia Adult Patients
试验速览
- 阶段
- 不适用
- 状态
- 招募中
- 入组人数
- 200
- 试验地点
- 1
- 主要终点
- Disease-free survival
研究概览
简要总结
Non-intensive But Non-interruptive Treatment based on previously study RALL-2016 of Adult Ph-negative Acute Lymphoblastic Leukemia: 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 remission (CR) with MRD-positive status after 2nd induction receive consolidation 1-3 with venetoclax (56 days), and B-ALL patients in complete remission (CR) with MRD-positive status after 2nd induction receive 1 consolidation with blinatumomab. After that consolidation bone samples are collected and tested for MRD and patients will continue therapy by protocol without HSCT if MRD-negative (by flow cytometry by aberrant immunophenotype in a centralized lab) status was achieved.
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 and B-ALL patients are being study MRD (by FCM) MRD-positive patients with T-ALL will receive 1-3 consolidation with venetoclax (400 mg/d), and B-ALL patients will receive1 additional consolidation by blinatumomab
- Non-interruptive 5 consolidation phases with dose modification according to WBC and platelets count after CR achievement. Rotation of consolidation is permitted
- 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 allo-HSCT
- Allo-HSCT is planned only for very high risk patients (11q23 ALL, MRD positivity after target therapy, ETP T-ALL)
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
- 18 Years 至 55 Years（Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •age 18-55 years old of patient,
- •Clinical diagnosis of non-treated Ph-negative ALL
排除标准
- •age more than 55 years old,
- •Clinical diagnosis of Ph-positive ALL
- •Clinical diagnosis of relapsed/refractory ALL,
研究组 & 干预措施
MRD-positive with Target therapy
MRD-positive patients after induction therapy in target therapy group (for B-ALL- blinatumomab, for T-ALL - venetoclax+ChT)
干预措施: blinatumomab for B-ALL, venetoclax for T-ALL (Drug)
结局指标
主要结局
Disease-free survival
时间窗: 3-year
Rate of Diseases-free survival in MRD-positive ALL patients
次要结局
- MRD-negativity after target therapy(1 month)
- Overall survival(3-yaers OS)