Optimal Treatment Strategy Based on Prognostic Groups for Pediatric de Novo Acute Myeloid Leukemia
试验速览
- 阶段
- 2 期
- 入组人数
- 350
- 试验地点
- 3
- 主要终点
- Rate of event free survival
研究概览
简要总结
The purpose of this study is to optimize therapy according to the known risk factors and treatment response in pediatric acute myeloid leukemia (AML)
详细描述
I. Risk group assessment Favorable prognosis group: Low risk features + Good response
Intermediate prognosis group:
- Low risk features + Delayed response-1
- Standard risk features + Good response
- Standard risk features + Delayed response-1
Poor prognosis group:
- Any high risk features irrespective of treatment response
- Any delayed response-2 irrespective of risk features
- Any refractory state irrespective of risk features
- Any early relapse
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
入排标准
- 年龄范围
- — 至 18 Years（Child, Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Patients who were newly diagnosed with de novo AML
- •Patients who had recurrent cytogenetic abnormalities of AML even though the bone marrow blast percent is lower than 20%
排除标准
- •Acute promyelocytic leukemia
- •Down syndrome AML
- •Therapy-related AML
- •AML developed from myelodysplastic syndrome or other marrow failure syndrome
- •Isolated myeloid sarcoma without bone marrow involvement
- •Patients who cannot undergo chemotherapy as scheduled due to serious complications at diagnosis
研究组 & 干预措施
Pediatric de novo acute myeloid leukemia
I. Chemotherapy Induction-1: Cytarabine + idarubicin Induction-2: High dose (HD) cytarabine + mitoxantrone Consolidation-1: Cytarabine + idarubicin Consolidation-2: HD cytarabine + etoposide Consolidation-3: HD cytarabine + mitoxantrone Consolidation-4: HD cytarabine + etoposide
II. Allogeneic hematopoietic stem cell transplantation (HSCT) Favorable prognosis group: chemotherapy only Intermediate prognosis group: chemotherapy or HSCT with reduced intensity conditioning Poor prognosis group: HSCT with myeloablative conditioning
干预措施: Cytarabine (Drug)
Pediatric de novo acute myeloid leukemia
I. Chemotherapy Induction-1: Cytarabine + idarubicin Induction-2: High dose (HD) cytarabine + mitoxantrone Consolidation-1: Cytarabine + idarubicin Consolidation-2: HD cytarabine + etoposide Consolidation-3: HD cytarabine + mitoxantrone Consolidation-4: HD cytarabine + etoposide
II. Allogeneic hematopoietic stem cell transplantation (HSCT) Favorable prognosis group: chemotherapy only Intermediate prognosis group: chemotherapy or HSCT with reduced intensity conditioning Poor prognosis group: HSCT with myeloablative conditioning
干预措施: Idarubicin (Drug)
Pediatric de novo acute myeloid leukemia
I. Chemotherapy Induction-1: Cytarabine + idarubicin Induction-2: High dose (HD) cytarabine + mitoxantrone Consolidation-1: Cytarabine + idarubicin Consolidation-2: HD cytarabine + etoposide Consolidation-3: HD cytarabine + mitoxantrone Consolidation-4: HD cytarabine + etoposide
II. Allogeneic hematopoietic stem cell transplantation (HSCT) Favorable prognosis group: chemotherapy only Intermediate prognosis group: chemotherapy or HSCT with reduced intensity conditioning Poor prognosis group: HSCT with myeloablative conditioning
干预措施: Mitoxantrone (Drug)
Pediatric de novo acute myeloid leukemia
I. Chemotherapy Induction-1: Cytarabine + idarubicin Induction-2: High dose (HD) cytarabine + mitoxantrone Consolidation-1: Cytarabine + idarubicin Consolidation-2: HD cytarabine + etoposide Consolidation-3: HD cytarabine + mitoxantrone Consolidation-4: HD cytarabine + etoposide
II. Allogeneic hematopoietic stem cell transplantation (HSCT) Favorable prognosis group: chemotherapy only Intermediate prognosis group: chemotherapy or HSCT with reduced intensity conditioning Poor prognosis group: HSCT with myeloablative conditioning
干预措施: Etoposide (Drug)
Pediatric de novo acute myeloid leukemia
I. Chemotherapy Induction-1: Cytarabine + idarubicin Induction-2: High dose (HD) cytarabine + mitoxantrone Consolidation-1: Cytarabine + idarubicin Consolidation-2: HD cytarabine + etoposide Consolidation-3: HD cytarabine + mitoxantrone Consolidation-4: HD cytarabine + etoposide
II. Allogeneic hematopoietic stem cell transplantation (HSCT) Favorable prognosis group: chemotherapy only Intermediate prognosis group: chemotherapy or HSCT with reduced intensity conditioning Poor prognosis group: HSCT with myeloablative conditioning
干预措施: Hematopoietic stem cell transplantation (Procedure)
结局指标
主要结局
Rate of event free survival
时间窗: Up to 5 years
次要结局
- Proportion of patients who achieved complete remission(Up to 3 months)