Optimal Treatment Strategy Based on for Pediatric AML

Study Overview
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Brief Summary
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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
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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 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

Official Title
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Optimal Treatment Strategy Based on Prognostic Groups for Pediatric de Novo Acute Myeloid Leukemia

Conditions
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Pediatric Acute Myeloid Leukemia

Intervention / Treatment
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* Drug: Cytarabine
* Drug: Idarubicin
* Drug: Mitoxantrone
* Drug: Etoposide
* Procedure: Hematopoietic stem cell transplantation


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: 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% Exclusion Criteria: 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

Ages Eligible for Study
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Maximum Age: 18 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Intervention Model: Single Group Assignment


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Pediatric de novo acute myeloid leukemia<br>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 | Drug: Cytarabine<br> <br> Drug: Idarubicin<br> <br> Drug: Mitoxantrone<br> <br> Drug: Etoposide<br> <br> Procedure: Hematopoietic stem cell transplantation<br> <br> |

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Rate of event free survival |  | Up to 5 years | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Proportion of patients who achieved complete remission |  | Up to 3 months |