Treatment of Newly Diagnosed Standard Risk Acute Lymphoblastic Leukemia in Children
Study Details
Study Description
Brief Summary
Aim of this study is to investigate the outcome of NGS MRD based risk stratified treatment for standard risk acute lymphoblastic leukemia in children and adolescents.
Condition or Disease | Intervention/Treatment | Phase |
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Phase 2 |
Study Design
Arms and Interventions
Arm | Intervention/Treatment |
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Experimental: Standard-low (SL) Induction-> SL Consolidation(4weeks)-> Interim Maintenance 1st-> Delayed Intesificaion-> Interim Maintenance 2nd-> Maintenance |
Drug: induction: vincristine, L-asparaginase, dexamethasone, intrathecal Ara-C, intrathecal Methotrexate
vincristine 1.5mg/m2 L-asparaginase 6,000U/m2 Dexamethasone 6mg/m2 Intrathecal Cytarabine Intrathecal Methotreate
Drug: Consolidation: Vincristine, Mecaptopurine, Intrathecal Methotrexate
Vincristine 1.5mg/m2 Mecaptopurine 50mg/m2 Cyclophosphamide 1,000mg/m2 Cytarabine 75mg/m2 L-asparaginase 6,000U/m2 Intrathecal Methotrexate
Drug: Interim Maintenance(IM): Vincristine, Methotrexate, Intrathecal Methotrexate
Vincristine 1.5mg/m2 Methotrexate 5,000mg/m2 Intrathecal Methotrexate
Drug: Delayed Intesification(DI): Vincristine, Mercaptopurine, L-asparaginase, Doxorubicin, Cyclophosphamide, Cytarabine, Dexamethasone, Intrathecal Methotrexate
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
Drug: Maintenance: Vincristine, Mercaptopurine, Methotrexate, Dexamethasone, Intrathecal Methotrexate
Vincristine 1.5mg/m2 Mercaptopurine 50mg/m2 Methotrexate 20mg/m2 Dexamethasone 6mg/m2 Intrathecal Methotrexate
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Experimental: Standard-average (SA) Induction-> SH Consolidation(8weeks)-> Interim Maintenance 1st-> Delayed Intesificaion-> Interim Maintenance 2nd-> Maintenance |
Drug: induction: vincristine, L-asparaginase, dexamethasone, intrathecal Ara-C, intrathecal Methotrexate
vincristine 1.5mg/m2 L-asparaginase 6,000U/m2 Dexamethasone 6mg/m2 Intrathecal Cytarabine Intrathecal Methotreate
Drug: Consolidation: Vincristine, Mecaptopurine, Cyclophosphamide, Cytarabine, L-asparaginase, Intrathecal Methotrexate
Vincristine 1.5mg/m2 Mecaptopurine 50mg/m2 Cyclophosphamide 1,000mg/m2 Cytarabine 75mg/m2 L-asparaginase 6,000IU/m2 Intrathecal Methotrexate
Drug: Interim Maintenance(IM): Vincristine, Methotrexate, Intrathecal Methotrexate
Vincristine 1.5mg/m2 Methotrexate 5,000mg/m2 Intrathecal Methotrexate
Drug: Delayed Intesification(DI): Vincristine, Mercaptopurine, L-asparaginase, Doxorubicin, Cyclophosphamide, Cytarabine, Dexamethasone, Intrathecal Methotrexate
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
Drug: Maintenance: Vincristine, Mercaptopurine, Methotrexate, Dexamethasone, Intrathecal Methotrexate
Vincristine 1.5mg/m2 Mercaptopurine 50mg/m2 Methotrexate 20mg/m2 Dexamethasone 6mg/m2 Intrathecal Methotrexate
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Experimental: Standard-high 1 (SH1) Induction-> SL Consolidation(4weeks)-> SH Consolidattion(4weeks)-> Interim Maintenance 1st-> Delayed Intesificaion 1st-> Interim Maintenance 2nd-> Delayed Intestificaion 2nd-> Maintenance |
Drug: induction: vincristine, L-asparaginase, dexamethasone, intrathecal Ara-C, intrathecal Methotrexate
vincristine 1.5mg/m2 L-asparaginase 6,000U/m2 Dexamethasone 6mg/m2 Intrathecal Cytarabine Intrathecal Methotreate
Drug: Consolidation: Vincristine, Mecaptopurine, Cyclophosphamide, Cytarabine, L-asparaginase, Intrathecal Methotrexate
Vincristine 1.5mg/m2 Mecaptopurine 50mg/m2 Cyclophosphamide 1,000mg/m2 Cytarabine 75mg/m2 L-asparaginase 6,000IU/m2 Intrathecal Methotrexate
Drug: Interim Maintenance(IM): Vincristine, Methotrexate, Mercaptopurine, Intrathecal Methotrexate
Vincristine 1.5mg/m2 Methotrexate 5,000mg/m2 Mecaptopurine: 25mg/m2 Intrathecal Methotrexate
Drug: Delayed Intesification(DI): Vincristine, L-asparaginase, Doxorubicin, Cyclophosphamide, Cytarabine, Dexamethasone, Intrathecal Methotrexate
Vincristine 1.5mg/m2 L-asparaginase 6,000IU/m2 Doxorubicin 25mg/m2 Cyclophosphamide 1,000mg/m2 Cytarabine 100mg/m2 Dexamethasone 6mg/m2 Intrathecal Methotrexate
Drug: Maintenance: Vincristine, Mercaptopurine, Methotrexate, Dexamethasone, Intrathecal Methotrexate
Vincristine 1.5mg/m2 Mercaptopurine 50mg/m2 Methotrexate 20mg/m2 Dexamethasone 6mg/m2 Intrathecal Methotrexate
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Experimental: Standard-high 2 (SH2) Induction-> SH Consolidattion(8weeks)-> Interim Maintenance 1st-> Delayed Intesificaion 1st-> Interim Maintenance 2nd-> Delayed Intestificaion 2nd-> Maintenance |
Drug: induction: vincristine, L-asparaginase, dexamethasone, intrathecal Ara-C, intrathecal Methotrexate
vincristine 1.5mg/m2 L-asparaginase 6,000U/m2 Dexamethasone 6mg/m2 Intrathecal Cytarabine Intrathecal Methotreate
Drug: Consolidation: Vincristine, Mecaptopurine, Cyclophosphamide, Cytarabine, L-asparaginase, Intrathecal Methotrexate
Vincristine 1.5mg/m2 Mecaptopurine 50mg/m2 Cyclophosphamide 1,000mg/m2 Cytarabine 75mg/m2 L-asparaginase 6,000IU/m2 Intrathecal Methotrexate
Drug: Interim Maintenance(IM): Vincristine, Methotrexate, Mercaptopurine, Intrathecal Methotrexate
Vincristine 1.5mg/m2 Methotrexate 5,000mg/m2 Mecaptopurine: 25mg/m2 Intrathecal Methotrexate
Drug: Delayed Intesification(DI): Vincristine, L-asparaginase, Doxorubicin, Cyclophosphamide, Cytarabine, Dexamethasone, Intrathecal Methotrexate
Vincristine 1.5mg/m2 L-asparaginase 6,000IU/m2 Doxorubicin 25mg/m2 Cyclophosphamide 1,000mg/m2 Cytarabine 100mg/m2 Dexamethasone 6mg/m2 Intrathecal Methotrexate
Drug: Maintenance: Vincristine, Mercaptopurine, Methotrexate, Dexamethasone, Intrathecal Methotrexate
Vincristine 1.5mg/m2 Mercaptopurine 50mg/m2 Methotrexate 20mg/m2 Dexamethasone 6mg/m2 Intrathecal Methotrexate
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Outcome Measures
Primary Outcome Measures
- 5-year event free survival rate [Up to 5-years]
Secondary Outcome Measures
- Confirmation of the therapeutic effect of the initial treatment response [Up to 5-years]
Relapse-free survival between two groups(NGS-MRD positive vs. NGS MRD negative after induction) offsets by NGS MRD based stratified treatment
- Disease prognosis-related factor [Up to 5-years]
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.
Eligibility Criteria
Criteria
Inclusion Criteria:
- Newly diagnosed pediatric/adolescent acute lymphomblastic leukemia patient with NCL standard risk that stratifies all 1-5 of following
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1 year old ≤ Age < 10 years old
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white blood cell at initial diagnosis < 5x10^10/L (50,000uL)
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CNS 1 or 2
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No testis involvement
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Satisfaction of following organ functions
- Kidney function (satisfies i or ii)
- Creatinine clearance (or radioisotope-measured GFR) ≥ 70mL/min/1.73m2
- 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
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Liver function i. Direct bilirubin < 3.0mg/dL
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Cardiac function i. Shortening fraction ≥ 27% confirmed by cardiac echography
- Ejection fraction ≥ 50% confirmed by cardiac echography
Exclusion Criteria:
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Steroid administration within 2 weeks before the diagnosis
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t(9;22) or t(4;11)(q11;q23) or chromosome < 44 or iAMP21 or t(17;19)/TCF3-HLF
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One of the following syndromes: Down syndrome, Bloom syndrome, ataxia-telangiectasia, Fanconi anemia, Kostmann syndrome, Shwachman-Diamond syndrome, or other bone marrow failure syndrome
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Burkitt leukemia/lymphoma
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When the clinical trial subject(or legal representative) does not consent or is unable to give written consent
Contacts and Locations
Locations
No locations specified.Sponsors and Collaborators
- Hee Young Ju
Investigators
None specified.Study Documents (Full-Text)
None provided.More Information
Publications
None provided.- 2023-09-142