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| Name | Class |
|---|---|
| Asan Medical Center | OTHER |
| Seoul National University Hospital | OTHER |
| Seoul St. Mary's Hospital | OTHER |
| Severance Hospital |
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Aim of this study is to investigate the outcome of NGS MRD based risk stratified treatment for high risk acute lymphoblastic leukemia in children and adolescents.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Standard-low (SL) | Experimental | Induction-> SL Consolidation(4weeks)-> Interim Maintenance 1st-> Delayed Intesificaion-> Interim Maintenance 2nd-> Maintenance |
|
| Standard-average (SA) | Experimental | Induction-> SH Consolidation(4weeks)-> Intensified Consolidation(4weeks)-> Interim Maintenance 1st-> Delayed Intesificaion-> Interim Maintenance 2nd-> Maintenance |
|
| Standard-high 1 (SH1) | Experimental | Induction-> SL Consolidation(4weeks)-> Intesified Consolidattion(4weeks)-> Interim Maintenance 1st-> Delayed Intesificaion 1st-> Interim Maintenance 2nd-> Delayed Intestificaion 2nd-> Maintenance |
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| induction: vincristine, L-asparaginase, dexamethasone, intrathecal Ara-C, intrathecal Methotrexate | Drug | vincristine 1.5mg/m2 L-asparaginase 6,000U/m2 Dexamethasone 6mg/m2 Intrathecal Cytarabine Intrathecal Methotreate |
| Measure | Description | Time Frame |
|---|---|---|
| 5-year event free survival rate | Up to 5-years |
| Measure | Description | Time Frame |
|---|---|---|
| Confirmation of the therapeutic effect of the initial treatment response | Relapse-free survival between two groups(NGS-MRD positive vs. NGS MRD negative after induction) offsets by NGS MRD based stratified treatment | Up to 5-years |
| Disease prognosis-related factor |
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<Inclusion Criteria>
Newly diagnosed pediatric/adolescent acute lymphomblastic leukemia patient with NCL standard risk that stratifies all 1-4 of following
A. Kidney function (satisfies i or ii) i. Creatinine clearance (or radioisotope-measured GFR) ≥ 70mL/min/1.73m2 ii. Creatinine value according to age/sec satisfies the following:
1 to < 2 years: Male: 0.6 / Female: 0.6, 2 to < 6 years: Male: 0.8 / Female: 0.8, 6 to < 10 years: Male: 1 / Female: 1, 10 to < 13 years: Male: 1.2 / Female: 1.2, 13 to < 16 years: Male: 1.5 / Female: 1.4, ≥ 16 years: Male: 1.7 / Female: 1.4 However, subjects who meet the selection criteria within 1 week before registration after receiving appropriate conservative treatment, including fluid therapy, can be registered.
B. Liver function i. Direct bilirubin < 3.0mg/dL
<Exclusion Criteria>
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| Name | Role | Phone | Extension | |
|---|---|---|---|---|
| Hee Young Ju, MD, Phd | Contact | 82-2-3410-0865 | heeyoung.ju@samsung.com | |
| hyunjung Shin | Contact | 82-2-3410-6763 | hjds.shin@samsung.com |
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| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Asan Medical Center | Recruiting | Seoul | Other (Non U.s.) | 03174 | South Korea |
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| OTHER |
| Pusan National University Yangsan Hospital | OTHER |
| Korea University Anam Hospital | OTHER |
| Chonnam National University Hospital | OTHER |
| Jeju National University Hospital | OTHER |
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| Standard-high 2 (SH2) | Experimental | Induction-> SH Consolidation(4weeks)-> Intensified Consolidation(4weeks)-> Interim Maintenance 1st-> Delayed Intesificaion 1st-> Interim Maintenance 2nd-> Delayed Intestificaion 2nd-> Maintenance |
|
| Consolidation: Vincristine, Mecaptopurine, Intrathecal Methotrexate | Drug | Vincristine 1.5mg/m2 Mecaptopurine 50mg/m2 Cyclophosphamide 1,000mg/m2 Cytarabine 75mg/m2 L-asparaginase 6,000U/m2 Intrathecal Methotrexate |
|
| Consolidation: Vincristine, Mecaptopurine, Cyclophosphamide, Cytarabine, L-asparaginase, Intrathecal Methotrexate | Drug | Vincristine 1.5mg/m2 Mecaptopurine 50mg/m2 Cyclophosphamide 1,000mg/m2 Cytarabine 75mg/m2 L-asparaginase 6,000IU/m2 Intrathecal Methotrexate |
|
| Interim Maintenance(IM): Vincristine, Methotrexate, Intrathecal Methotrexate | Drug | Vincristine 1.5mg/m2 Methotrexate 5,000mg/m2 Intrathecal Methotrexate |
|
| Interim Maintenance(IM): Vincristine, Methotrexate, Mercaptopurine, Intrathecal Methotrexate | Drug | Vincristine 1.5mg/m2 Methotrexate 5,000mg/m2 Mecaptopurine: 25mg/m2 Intrathecal Methotrexate |
|
| Delayed Intesification(DI): Vincristine, Mercaptopurine, L-asparaginase, Doxorubicin, Cyclophosphamide, Cytarabine, Dexamethasone, Intrathecal Methotrexate | Drug | Vincristine 1.5mg/m2 Mercaptopurine 50mg/m2 L-asparaginase 6,000IU/m2 Doxorubicin 25mg/m2 Cyclophosphamide 1,000mg/m2 Cytarabine 75mg/m2 Dexamethasone 10mg/m2 Intrathecal Methotrexate |
|
| Delayed Intesification(DI): Vincristine, L-asparaginase, Doxorubicin, Cyclophosphamide, Cytarabine, Dexamethasone, Intrathecal Methotrexate | Drug | Vincristine 1.5mg/m2 L-asparaginase 6,000IU/m2 Doxorubicin 25mg/m2 Cyclophosphamide 1,000mg/m2 Cytarabine 100mg/m2 Dexamethasone 6mg/m2 Intrathecal Methotrexate |
|
| Maintenance: Vincristine, Mercaptopurine, Methotrexate, Dexamethasone, Intrathecal Methotrexate | Drug | Vincristine 1.5mg/m2 Mercaptopurine 50mg/m2 Methotrexate 20mg/m2 Dexamethasone 6mg/m2 Intrathecal Methotrexate |
|
Relapse-free survival according to presence or absence of known good prognosis factors(high hyperdilpoidy, ETV6/RUNX1, Trisomy 4/10/17) have no clinical significance when NGS MRD based stratified treatment is performed. |
| Up to 5-years |
| Samsung Medical Center | Recruiting | Seoul | Other (Non U.s.) | 03174 | South Korea |
|
| Pusan National University Yangsan Hospital | Recruiting | Yangsan | Yangsan-si | 50612 | South Korea |
|
| Chonnam National University Hwasun Hospital | Not yet recruiting | Hwasun | 58128 | South Korea |
|
| Jeju National University Hospital | Not yet recruiting | Jeju City | 63241 | South Korea |
|
| Korea University Anam Hospital | Not yet recruiting | Seoul | 02841 | South Korea |
|
| Seoul National University Hospital | Recruiting | Seoul | 03080 | South Korea |
|
| Severance Hospital | Recruiting | Seoul | 03722 | South Korea |
|
| Seoul saint Mary's Hospital | Recruiting | Seoul | 06591 | South Korea |
|
| ID | Term |
|---|---|
| D001215 | Asparaginase |
| D003907 | Dexamethasone |
| D003520 | Cyclophosphamide |
| D003561 | Cytarabine |
| D008727 | Methotrexate |
| D015122 | Mercaptopurine |
| D004317 | Doxorubicin |
| ID | Term |
|---|---|
| D000581 | Amidohydrolases |
| D006867 | Hydrolases |
| D004798 | Enzymes |
| D045762 | Enzymes and Coenzymes |
| D011246 | Pregnadienetriols |
| D011245 | Pregnadienes |
| D011278 | Pregnanes |
| D013256 | Steroids |
| D000072473 | Fused-Ring Compounds |
| D011083 | Polycyclic Compounds |
| D013259 | Steroids, Fluorinated |
| D010752 | Phosphoramide Mustards |
| D009588 | Nitrogen Mustard Compounds |
| D009150 | Mustard Compounds |
| D006846 | Hydrocarbons, Halogenated |
| D006838 | Hydrocarbons |
| D009930 | Organic Chemicals |
| D063088 | Phosphoramides |
| D009943 | Organophosphorus Compounds |
| D003562 | Cytidine |
| D011741 | Pyrimidine Nucleosides |
| D011743 | Pyrimidines |
| D006573 | Heterocyclic Compounds, 1-Ring |
| D006571 | Heterocyclic Compounds |
| D001087 | Arabinonucleosides |
| D009705 | Nucleosides |
| D009706 | Nucleic Acids, Nucleotides, and Nucleosides |
| D000630 | Aminopterin |
| D011622 | Pterins |
| D011621 | Pteridines |
| D006574 | Heterocyclic Compounds, 2-Ring |
| D000072471 | Heterocyclic Compounds, Fused-Ring |
| D013438 | Sulfhydryl Compounds |
| D013457 | Sulfur Compounds |
| D011687 | Purines |
| D003630 | Daunorubicin |
| D018943 | Anthracyclines |
| D009279 | Naphthacenes |
| D011084 | Polycyclic Aromatic Hydrocarbons |
| D006841 | Hydrocarbons, Aromatic |
| D006844 | Hydrocarbons, Cyclic |
| D000617 | Aminoglycosides |
| D006027 | Glycosides |
| D002241 | Carbohydrates |
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