Optimal Treatment Strategy Based on for Pediatric AML

Samsung Medical Center350 enrolled

Overview

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

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

Study Type

INTERVENTIONAL

Allocation

Purpose

TREATMENT

Enrollment

350

Conditions

Pediatric Acute Myeloid Leukemia

Interventions

CytarabineDRUG

IdarubicinDRUG

MitoxantroneDRUG

EtoposideDRUG

Eligibility

Sex: ALLMax age: 18 Years

Medical Language ↔ Plain English

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

Locations (3)

Chonnam National University Hwasun Hospital

Chonnam, South Korea

RECRUITING

Samsung Medical Center

Seoul, South Korea

RECRUITING

St. Mary Hospital

Seoul, South Korea

RECRUITING

Outcomes

Primary Outcomes

Rate of event free survival

Time frame: Up to 5 years

Secondary Outcomes

Proportion of patients who achieved complete remission

Time frame: Up to 3 months

Central Contacts

Keon Hee Yoo, MD, PhD

CONTACT

82-2-3410-3532 hema2170@skku.edu

Data from ClinicalTrials.gov

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