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Optimal Treatment Strategy Based on for Pediatric AML

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Samsung Medical Center

Status and phase

Unknown
Phase 2

Conditions

Pediatric Acute Myeloid Leukemia

Treatments

Drug: Mitoxantrone
Procedure: Hematopoietic stem cell transplantation
Drug: Idarubicin
Drug: Cytarabine
Drug: Etoposide

Study type

Interventional

Funder types

Other

Identifiers

NCT02848183
2015-11-028

Details and patient eligibility

About

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

Full 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

Sex

All

Ages

Under 18 years old

Volunteers

No 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

Trial design

350 participants in 1 patient group

Pediatric de novo acute myeloid leukemia
Experimental group
Description:
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
Treatment:
Drug: Mitoxantrone
Procedure: Hematopoietic stem cell transplantation
Drug: Idarubicin
Drug: Cytarabine
Drug: Etoposide

Trial contacts and locations

3

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Central trial contact

Keon Hee Yoo, MD, PhD

Data sourced from clinicaltrials.gov

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