Optimal Treatment Strategy Based on for Pediatric AML

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

Status

UNKNOWN

Phases

Phase 2

Study type

Interventional

Source

ClinicalTrials.gov

Registry ID

NCT02848183

Enrollment

350

Registered

2016-07-28

Start date

2016-01-31

Completion date

Unknown

Last updated

2016-07-28

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Pediatric Acute Myeloid Leukemia

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

Interventions

DRUGCytarabine

DRUGIdarubicin

DRUGMitoxantrone

DRUGEtoposide

PROCEDUREHematopoietic stem cell transplantation

Study design

Allocation

Intervention model

SINGLE_GROUP

Primary purpose

TREATMENT

Eligibility

Sex/Gender

ALL

Age

No minimum to 18 Years

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

Design outcomes

Primary

Measure	Time frame
Rate of event free survival	Up to 5 years

Secondary

Measure	Time frame
Proportion of patients who achieved complete remission	Up to 3 months

Countries

South Korea

Contacts

Primary ContactKeon Hee Yoo, MD, PhD

hema2170@skku.edu82-2-3410-3532

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026