Optimal Treatment Strategy Based on for Pediatric AML

Pediatric Acute Myeloid Leukemia Clinical Trial

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

Status Recruiting

Clinical Trial 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)

Clinical Trial 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 ;

Study Design

Endpoint Classification: Safety/Efficacy Study, Intervention Model: Single Group Assignment, Primary Purpose: Treatment

Related Conditions & MeSH terms

• Leukemia
• Leukemia, Myeloid
• Leukemia, Myeloid, Acute
• Pediatric Acute Myeloid Leukemia

• NCT number: NCT02848183
• Study type: Interventional
• Source: Samsung Medical Center
• Contact: Keon Hee Yoo, MD, PhD
• Phone: 82-2-3410-3532
• Email: hema2170@skku.edu
• Status: Recruiting
• Phase: Phase 2
• Start date: January 2016