Optimal Treatment Strategy Based on for Pediatric AML
- Conditions
- Pediatric Acute Myeloid Leukemia
- Interventions
- Procedure: Hematopoietic stem cell transplantation
- Registration Number
- NCT02848183
- Lead Sponsor
- Samsung Medical Center
- Brief Summary
The purpose of this study is to optimize therapy according to the known risk factors and treatment response in pediatric acute myeloid leukemia (AML)
- Detailed Description
I. Risk group assessment Favorable prognosis group: Low risk features + Good response
Intermediate prognosis group:
1. Low risk features + Delayed response-1
2. Standard risk features + Good response
3. Standard risk features + Delayed response-1
Poor prognosis group:
1. Any high risk features irrespective of treatment response
2. Any delayed response-2 irrespective of risk features
3. Any refractory state irrespective of risk features
4. Any early relapse
II. 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
III. 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
Recruitment & Eligibility
- Status
- UNKNOWN
- Sex
- All
- Target Recruitment
- 350
- 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%
- 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
Study & Design
- Study Type
- INTERVENTIONAL
- Study Design
- SINGLE_GROUP
- Arm && Interventions
Group Intervention Description Pediatric de novo acute myeloid leukemia Hematopoietic stem cell transplantation 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 Pediatric de novo acute myeloid leukemia Cytarabine 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 Pediatric de novo acute myeloid leukemia Idarubicin 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 Pediatric de novo acute myeloid leukemia Etoposide 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 Pediatric de novo acute myeloid leukemia Mitoxantrone 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
- Primary Outcome Measures
Name Time Method Rate of event free survival Up to 5 years
- Secondary Outcome Measures
Name Time Method Proportion of patients who achieved complete remission Up to 3 months
Trial Locations
- Locations (3)
Chonnam National University Hwasun Hospital
🇰🇷Chonnam, Korea, Republic of
St. Mary Hospital
🇰🇷Seoul, Korea, Republic of
Samsung Medical Center
🇰🇷Seoul, Korea, Republic of