Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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UNKNOWN
PHASE2
350 participants
INTERVENTIONAL
2016-01-31
Brief Summary
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Detailed Description
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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
Conditions
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Study Design
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NA
SINGLE_GROUP
TREATMENT
Study Groups
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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
Cytarabine
Idarubicin
Mitoxantrone
Etoposide
Hematopoietic stem cell transplantation
Interventions
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Cytarabine
Idarubicin
Mitoxantrone
Etoposide
Hematopoietic stem cell transplantation
Eligibility Criteria
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Inclusion Criteria
* Patients who had recurrent cytogenetic abnormalities of AML even though the bone marrow blast percent is lower than 20%
Exclusion Criteria
* 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
18 Years
ALL
No
Sponsors
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Samsung Medical Center
OTHER
Responsible Party
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Locations
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Chonnam National University Hwasun Hospital
Chonnam, , South Korea
Samsung Medical Center
Seoul, , South Korea
St. Mary Hospital
Seoul, , South Korea
Countries
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Central Contacts
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Facility Contacts
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Other Identifiers
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2015-11-028
Identifier Type: -
Identifier Source: org_study_id
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