Optimal Treatment Strategy Based on for Pediatric AML | NCT02848183

Studies
Optimal Treatment Strategy Based on for Pediatric AML

NCT02848183

Sponsor

Samsung Medical Center

Status

Unknown status

Last Update Posted

Jul 28, 2016Estimated

Enrollment

350

Phase

Phase 2

Conditions

Pediatric Acute Myeloid Leukemia

Interventions

Cytarabine
Idarubicin
Mitoxantrone
Etoposide
Hematopoietic stem cell transplantation

Countries

South Korea

Protocol Section

Identification Module Status Module Sponsor/Collaborators Module Oversight Module Description Module Conditions Module Design Module Arms/Interventions Module Outcomes Module Eligibility Module Contacts/Locations Module References Module IPD Sharing Statement Module

Results Section

Participant Flow Module Baseline Characteristics Module Outcome Measures Module Adverse Events Module More Info Module

Annotation Section

Annotation Module

Document Section

Large Document Module

Derived Section

Miscellaneous Info Module Condition Browse Module Intervention Browse Module

Protocol Section

Identification Module

NCT ID

Results Section

No data available

No data is available for this block.

Annotation Section

No data available

No data is available for this block.

Document Section

No data available

No data is available for this block.

Derived Section

Miscellaneous Info Module

Version Holder

Status Module

Record Verification Date

Jul 2016

Overall Recruitment Status or Expanded Access Status

Unknown status

Last Known Status

Recruiting

Delayed Posting

Not provided

Why Stopped

Not provided

Expanded Access Info

Start Date

Jan 2016

Primary Completion Date

Dec 2020Estimated

Completion Date

Not provided

First Submitted Date

Jul 26, 2016

First Submission Date that Met QC Criteria

Jul 26, 2016

First Posted Date

Jul 28, 2016Estimated

Results Waived

Not provided

Results First Submitted Date

Not provided

Results First Submitted that Met QC Criteria

Not provided

Results First Posted Date

Not provided

Certification/Extension (aka Delayed Results) First Submitted Date

Not provided

Certification/Extension First Submitted that Passed QC Review

Not provided

Certification/Extension First Posted Date

Not provided

Last Update Submitted Date

Jul 26, 2016

Last Update Posted Date

Jul 28, 2016Estimated

Oversight Module

Has Data Monitoring Committee (DMC)

Is FDA Regulated Drug

Not provided

Is FDA Regulated Device

Not provided

Is Unapproved Device

Not provided

Pediatric Postmarket Surveillance of a Device Product

Not provided

Product Exported from US

Not provided

FDAAA801 Violation

Not provided

Description Module

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

Design Module

Study Type

Interventional

Number of References to an Expanded Access Study

Not provided

Expanded Access Types

Not provided

Patient Registry

Not provided

Target Follow-Up Duration

Not provided

Phases

Phase 2

Interventional Study Design

Allocation

Biospecimen

No data available

No data is available for this block.

Enrollment

350

Arms/Interventions Module

Arm Groups

Label	Type	Description	Intervention Names
Pediatric de novo acute myeloid leukemia	Experimental	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: Cytarabine Drug: Idarubicin Drug: Mitoxantrone Drug: Etoposide Procedure: Hematopoietic stem cell transplantation

Interventions

Name	Type	Description	Arm Group Labels	Other Names
Cytarabine	Drug		Pediatric de novo acute myeloid leukemia
Idarubicin

Outcomes Module

Primary Outcomes

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

Secondary Outcomes

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

Other Outcomes

Not provided

Eligibility Module

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

Accepts Healthy Volunteers

Sex

All

Sex/Gender Based

Not provided

Sex/Gender Description

Not provided

Minimum Age

Not provided

Maximum Age

18 Years

Standard Ages

ChildAdult

Study Population

Not provided

Sampling Method

Not provided

Contacts/Locations Module

Central Contacts

Name	Role	Phone	Extension	Email
Keon Hee Yoo, MD, PhD	Contact	82-2-3410-3532		hema2170@skku.edu

Overall Officials

Not provided

Locations

Facility	Status	City	State	ZIP	Country	Contacts
Chonnam National University Hwasun Hospital	Recruiting	Chonnam			South Korea

IPD Sharing Statement Module

Plan to Share IPD

Description

Not provided

Types

Not provided

Time Frame

Not provided

Access Criteria

Not provided

URL

Not provided

Intervention Browse Module

MeSH Terms

ID	Term
D003561	Cytarabine
D015255	Idarubicin
D008942	Mitoxantrone
D005047	Etoposide
D018380	Hematopoietic Stem Cell Transplantation

Ancestor Terms

ID	Term
D003562	Cytidine
D011741	Pyrimidine Nucleosides
D011743	Pyrimidines
D006573	Heterocyclic Compounds, 1-Ring

Browse Leaves

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Browse Branches

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