Optimal Treatment Strategy Based on for Pediatric AML

July 26, 2016 updated by: Samsung Medical Center

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

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

Study Overview

Status

Unknown

Conditions

Intervention / Treatment

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

Study Type

Interventional

Enrollment

350

Phase

  • Phase 2

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Korea, Republic of
      • Chonnam, Korea, Republic of
        • Recruiting
        • Chonnam National University Hwasun Hospital
        • Contact:
      • Seoul, Korea, Republic of
        • Recruiting
        • Samsung Medical Center
        • Contact:
      • Seoul, Korea, Republic of

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

No older than 18 years (Child, Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

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

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: N/A
  • Interventional Model: Single Group Assignment

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: 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
Drug: Mitoxantrone
Drug: Cytarabine
Drug: Etoposide
Drug: Idarubicin
Procedure: Hematopoietic stem cell transplantation

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Time Frame
Rate of event free survival
Time Frame: Up to 5 years
Up to 5 years

Secondary Outcome Measures

Outcome Measure
Time Frame
Proportion of patients who achieved complete remission
Time Frame: Up to 3 months
Up to 3 months

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Samsung Medical Center

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

January 1, 2016

Primary Completion (Anticipated)

December 1, 2020

Study Registration Dates

First Submitted

July 26, 2016

First Submitted That Met QC Criteria

July 26, 2016

First Posted (Estimate)

July 28, 2016

Study Record Updates

Last Update Posted (Estimate)

July 28, 2016

Last Update Submitted That Met QC Criteria

July 26, 2016

Last Verified

July 1, 2016

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

  • 2015-11-028

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

NO

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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