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Optimal Treatment Strategy Based on for Pediatric AML

Primary Purpose

Pediatric Acute Myeloid Leukemia

Status
Unknown status
Phase
Phase 2
Locations
Korea, Republic of
Study Type
Interventional
Intervention
Cytarabine
Idarubicin
Mitoxantrone
Etoposide
Hematopoietic stem cell transplantation
Sponsored by
Samsung Medical Center
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Pediatric Acute Myeloid Leukemia

Eligibility Criteria

undefined - 18 Years (Child, Adult)All SexesDoes not accept 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

Sites / Locations

  • Chonnam National University Hwasun HospitalRecruiting
  • Samsung Medical CenterRecruiting
  • St. Mary HospitalRecruiting

Arms of the Study

Arm 1

Arm Type

Experimental

Arm Label

Pediatric de novo acute myeloid leukemia

Arm 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

Outcomes

Primary Outcome Measures

Rate of event free survival

Secondary Outcome Measures

Proportion of patients who achieved complete remission

Full Information

First Posted
July 26, 2016
Last Updated
July 26, 2016
Sponsor
Samsung Medical Center
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1. Study Identification

Unique Protocol Identification Number
NCT02848183
Brief Title
Optimal Treatment Strategy Based on for Pediatric AML
Official Title
Optimal Treatment Strategy Based on Prognostic Groups for Pediatric de Novo Acute Myeloid Leukemia
Study Type
Interventional

2. Study Status

Record Verification Date
July 2016
Overall Recruitment Status
Unknown status
Study Start Date
January 2016 (undefined)
Primary Completion Date
December 2020 (Anticipated)
Study Completion Date
undefined (undefined)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Samsung Medical Center

4. Oversight

Data Monitoring Committee
No

5. Study Description

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: Low risk features + Delayed response-1 Standard risk features + Good response Standard risk features + Delayed response-1 Poor prognosis group: Any high risk features irrespective of treatment response Any delayed response-2 irrespective of risk features Any refractory state irrespective of risk features 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

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Pediatric Acute Myeloid Leukemia

7. Study Design

Primary Purpose
Treatment
Study Phase
Phase 2
Interventional Study Model
Single Group Assignment
Allocation
N/A
Enrollment
350 (false)

8. Arms, Groups, and Interventions

Arm Title
Pediatric de novo acute myeloid leukemia
Arm Type
Experimental
Arm 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
Intervention Type
Drug
Intervention Name(s)
Cytarabine
Intervention Type
Drug
Intervention Name(s)
Idarubicin
Intervention Type
Drug
Intervention Name(s)
Mitoxantrone
Intervention Type
Drug
Intervention Name(s)
Etoposide
Intervention Type
Procedure
Intervention Name(s)
Hematopoietic stem cell transplantation
Primary Outcome Measure Information:
Title
Rate of event free survival
Time Frame
Up to 5 years
Secondary Outcome Measure Information:
Title
Proportion of patients who achieved complete remission
Time Frame
Up to 3 months

10. Eligibility

Sex
All
Maximum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
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
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Keon Hee Yoo, MD, PhD
Phone
82-2-3410-3532
Email
hema2170@skku.edu
Facility Information:
Facility Name
Chonnam National University Hwasun Hospital
City
Chonnam
Country
Korea, Republic of
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Hoon Kook, MD, PhD
Email
hoonkook@chonnam.ac.kr
Facility Name
Samsung Medical Center
City
Seoul
Country
Korea, Republic of
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Keon Hee, MD, PhD
Phone
82-2-3410-3532
Email
hema2170@skku.edu
Facility Name
St. Mary Hospital
City
Seoul
Country
Korea, Republic of
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Bin Cho, MD, PhD
Email
chobinkr@catholic.ac.kr

12. IPD Sharing Statement

Plan to Share IPD
No

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Optimal Treatment Strategy Based on for Pediatric AML

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