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

Samsung Medical Center3 sites in 1 country350 target enrollmentJanuary 2016

ConditionsPediatric Acute Myeloid Leukemia

InterventionsCytarabine Idarubicin Mitoxantrone Etoposide Hematopoietic stem cell transplantation

DrugsCytarabine Idarubicin Mitoxantrone Etoposide

Overview

Phase: Phase 2
Intervention: Cytarabine
Conditions: Pediatric Acute Myeloid Leukemia
Sponsor: Samsung Medical Center
Enrollment: 350
Locations: 3
Primary Endpoint: Rate of event free survival
Last Updated: 9 years ago

Overview Investigators Eligibility Criteria Arms & Interventions Outcomes Sites Similar Trials

Overview

Brief 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

Registry

clinicaltrials.gov

Start Date

January 2016

End Date

December 2020

Last Updated

9 years ago

Study Type

Interventional

Study Design

Single Group

Sex

All

Investigators

Sponsor

Samsung Medical Center

Responsible Party

Sponsor

Eligibility Criteria

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

Arms & Interventions

Pediatric de novo acute myeloid leukemia

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

Intervention: Cytarabine