Treatment of BCR-ABL Negative ALL in Adults According to MRD and Genetics
试验速览
- 阶段
- 不适用
- 状态
- 招募中
- 发起方
- 入组人数
- 300
- 试验地点
- 83
- 主要终点
- Overall survival
研究概览
简要总结
After consolidation therapy adult patients (≥18 yr) with Ph-negative ALL will be treated with continuation chemotherapy or allogeneic hematopoietic stem cell transplantation (alloHSCT) according to both measurable residual disease (MRD) and results of genetic study performed at baseline.
详细描述
Patients will be uniformly treated with four drug-induction: vincristine (VCR), prednisone (PDN), pegylated asparaginase (PegASP), daunorubicin (DNR).
Resistant patients will receive a second induction with fludarabine, Ara-C, G-Colony-Stimulating Factor (G-CSF) and idarubicin (FLAG-IDA).
Patients with adequate MRD clearance after induction will receive 3 blocks of early consolidation. If adequate MRD clearance and good genetic background, the patients will proceed to delayed intensification, reinduction and maintenance. The remaining patients will receive early or delayed alloHSCT.
研究设计
- 研究类型
- Interventional
- 分配方式
- Non Randomized
- 干预模型
- Parallel
- 主要目的
- Treatment
- 盲法
- None
入排标准
- 年龄范围
- 18 Years 至 60 Years（Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Patients 18-60 yr with de novo Ph-neg ALL
- •Eastern Cooperative Oncology Group (ECOG) 0-2 (or >2 if due to ALL)
- •Informed consent
排除标准
- •Mature B-ALL, Ph+ ALL or blast crisis of chronic myeloid leukemia (CML), ALL of ambiguous lineage
- •ECOG >2 not due to ALL
- •Impaired cardiac, respiratory, hepatic or renal function not due to ALL
- •Pregnancy
- •HIV positivity
- •Severe psychiatric disease
- •Negative to sign informed consent.
研究组 & 干预措施
CHEMOTHERAPY
Pediatric-type of chemotherapy
干预措施: Pediatric-type of chemotherapy (Drug)
allogeneic HSCT
allogeneic HSCT
干预措施: allogeneic HSCT (Procedure)
结局指标
主要结局
Overall survival
时间窗: 3 years
Time from diagnosis to death or last follow-up
次要结局
- Complete remission (CR) rate(4 or 8 weeks after treatment onset)
- MRD status after induction and consolidation(After induction (4-8 weeks) and consolidation (16-20 weeks))