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Optimal Treatment Strategy Based on for Pediatric AML

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ClinicalTrials.gov Identifier: NCT02848183
Recruitment Status : Recruiting
First Posted : July 28, 2016
Last Update Posted : July 28, 2016
Sponsor:
Information provided by (Responsible Party):
Samsung Medical Center

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)

Condition or disease Intervention/treatment Phase
Pediatric Acute Myeloid Leukemia Drug: Cytarabine Drug: Idarubicin Drug: Mitoxantrone Drug: Etoposide Procedure: Hematopoietic stem cell transplantation Phase 2

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


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Study Type : Interventional  (Clinical Trial)
Enrollment : 350 participants
Intervention Model: Single Group Assignment
Primary Purpose: Treatment
Official Title: Optimal Treatment Strategy Based on Prognostic Groups for Pediatric de Novo Acute Myeloid Leukemia
Study Start Date : January 2016
Estimated Primary Completion Date : December 2020


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



Primary Outcome Measures :
  1. Rate of event free survival [ Time Frame: Up to 5 years ]

Secondary Outcome Measures :
  1. Proportion of patients who achieved complete remission [ Time Frame: Up to 3 months ]


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Ages Eligible for Study:   up to 18 Years   (Child, Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02848183


Contacts
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Contact: Keon Hee Yoo, MD, PhD 82-2-3410-3532 hema2170@skku.edu

Locations
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Korea, Republic of
Chonnam National University Hwasun Hospital Recruiting
Chonnam, Korea, Republic of
Contact: Hoon Kook, MD, PhD       hoonkook@chonnam.ac.kr   
Samsung Medical Center Recruiting
Seoul, Korea, Republic of
Contact: Keon Hee, MD, PhD    82-2-3410-3532    hema2170@skku.edu   
St. Mary Hospital Recruiting
Seoul, Korea, Republic of
Contact: Bin Cho, MD, PhD       chobinkr@catholic.ac.kr   
Sponsors and Collaborators
Samsung Medical Center

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Responsible Party: Samsung Medical Center
ClinicalTrials.gov Identifier: NCT02848183     History of Changes
Other Study ID Numbers: 2015-11-028
First Posted: July 28, 2016    Key Record Dates
Last Update Posted: July 28, 2016
Last Verified: July 2016
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No
Additional relevant MeSH terms:
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Leukemia
Leukemia, Myeloid
Leukemia, Myeloid, Acute
Neoplasms by Histologic Type
Neoplasms
Cytarabine
Etoposide
Mitoxantrone
Idarubicin
Etoposide phosphate
Antineoplastic Agents, Phytogenic
Antineoplastic Agents
Topoisomerase II Inhibitors
Topoisomerase Inhibitors
Enzyme Inhibitors
Molecular Mechanisms of Pharmacological Action
Antimetabolites, Antineoplastic
Antimetabolites
Antiviral Agents
Anti-Infective Agents
Immunosuppressive Agents
Immunologic Factors
Physiological Effects of Drugs
Analgesics
Sensory System Agents
Peripheral Nervous System Agents
Antibiotics, Antineoplastic