Treatment of Newly Diagnosed High Risk Acute Lymphoblastic Leukemia in Children
试验速览
- 阶段
- 2 期
- 发起方
- 入组人数
- 110
- 试验地点
- 1
- 主要终点
- event-free survival of SER group
研究概览
简要总结
Treatment of pediatric acute lymphoblastic leukemia (ALL) has advanced and the overall survival exceeds 80% nowadays. However the overall survival of high risk ALL remains 75-90%, thus recent studies focus on treatment intensification according to the risk group. According to the previous reports, we designed a multicenter prospective trial for pediatric ALL.
详细描述
Purpose of the study
- For slow early responder (SER), to confirm if the augmented interim maintenance using intravenous high dose methotrexate will improve the treatment outcome.
- For slow early responder (SER), to confirm if removal of prophylactic radiotherapy will relieve long term complications.
- To predict the treatment response and prognosis high risk pediatric ALL by monitoring of minimal residual disease (MRD).
Inclusion criteria
-
Diagnosis
-
Newly diagnosed B-precursor ALL meeting criteria 1.2
-
Newly diagnosed B-precursor ALL who was previously treated with steroid.
-
Newly diagnosed T cell ALL, excluding early T-cell precursor (ETP) leukemia
研究设计
- 研究类型
- Interventional
- 分配方式
- Non Randomized
- 干预模型
- Single Group
- 主要目的
- Treatment
- 盲法
- None
入排标准
- 年龄范围
- 1 Year 至 21 Years（Child, Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Newly diagnosed B-precursor ALL meeting criteria 1.2
- •Newly diagnosed B-precursor ALL who was previously treated with steroid.
- •Newly diagnosed T cell ALL, excluding early T-cell precursor (ETP) leukemia
- •1.2 Initial WBC count
- •from 1 years old to 9 years old : WBC ≥ 50,000/μL
- •from 10 years old to 21 years old : Any WBC
- •from 1 years old to 21 years old : Any WBC with Testicular leukemia or CNS leukemia (CNS3)
排除标准
- •Philadelphia chromosome (+) or bcr/abl rearrangement (+)
- •Chromosome <45 by cytogenetics
- •Induction failure (Day 28 M3 marrow (>25% blasts))
- •t(4:11) (as identified by cytogenetics, FISH or molecular studies)
- •Early T-cell precursor leukemia
- •Down syndrome ALL
研究组 & 干预措施
Slow early responder group
Includes : SER, Testis(+), CNS 3, T-cell (non ETP), Initial PB WBC ≥ 100,000/μL
- SER Consolidation
- Intrathecal triple chemotherapy at d0, 7, 14, 21 2. SER Interim Maintenance #1
- high dose methotrexate included
- Intrathecal triple chemotherapy at d0, 28 3. SER Delayed Intensification #1
- Intrathecal triple chemotherapy at d0, 28, 35 4. SER Interim Maintenance #2
- high dose methotrexate included
- Intrathecal triple chemotherapy at d0, 28 5. SER Delayed Intensification #2
- Intrathecal triple chemotherapy at d0, 28, 35 6. SER Maintenance
- Intrathecal triple chemotherapy at d0
干预措施: high dose methotrexate (Drug)
Slow early responder group
Includes : SER, Testis(+), CNS 3, T-cell (non ETP), Initial PB WBC ≥ 100,000/μL
- SER Consolidation
- Intrathecal triple chemotherapy at d0, 7, 14, 21 2. SER Interim Maintenance #1
- high dose methotrexate included
- Intrathecal triple chemotherapy at d0, 28 3. SER Delayed Intensification #1
- Intrathecal triple chemotherapy at d0, 28, 35 4. SER Interim Maintenance #2
- high dose methotrexate included
- Intrathecal triple chemotherapy at d0, 28 5. SER Delayed Intensification #2
- Intrathecal triple chemotherapy at d0, 28, 35 6. SER Maintenance
- Intrathecal triple chemotherapy at d0
干预措施: Intrathecal triple chemotherapy (Drug)
结局指标
主要结局
event-free survival of SER group
时间窗: 5 years from diagnosis
次要结局
- Number of adverse events(5 years from diagnosis)
研究者
Hee Young Shin
KSPHO
The Korean Society of Pediatric Hematology Oncology