Optimal Treatment Strategy Based on for Pediatric AML

Samsung Medical Center

Status and phase: Unknown; Phase 2

Conditions: Pediatric Acute Myeloid Leukemia

Treatments: Drug: Mitoxantrone; Procedure: Hematopoietic stem cell transplantation; Drug: Idarubicin; Drug: Cytarabine; Drug: Etoposide

Study type: Interventional

Funder types: Other

Identifiers

NCT02848183

2015-11-028

Details and patient eligibility

About

The purpose of this study is to optimize therapy according to the known risk factors and treatment response in pediatric acute myeloid leukemia (AML)

Full 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

Sex: All

Ages: Under 18 years old

Volunteers: No Healthy Volunteers

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

Trial design

350 participants in 1 patient group

Pediatric de novo acute myeloid leukemia

Experimental group

Description:

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

Treatment:

Drug: Mitoxantrone

Procedure: Hematopoietic stem cell transplantation

Drug: Idarubicin

Drug: Cytarabine

Drug: Etoposide