NCT02848183

Optimal Treatment Strategy Based on for Pediatric AML

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

• Status: Unknown
• Phase: Phase 2
• Study type: Interventional
• Enrollment: 350 (planned)
• Sponsor: Samsung Medical Center · Academic / Other
• Sex: All
• Age: 18 Years
• Healthy volunteers: Not accepted

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

Conditions

• Pediatric Acute Myeloid Leukemia

Interventions

Type	Name	Description
DRUG	Cytarabine
DRUG	Idarubicin
DRUG	Mitoxantrone
DRUG	Etoposide
PROCEDURE	Hematopoietic stem cell transplantation

Timeline

• Start date: 2016-01-01
• Primary completion: 2020-12-01
• First posted: 2016-07-28
• Last updated: 2016-07-28

Locations

3 sites across 1 country: South Korea