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Clinical Trials in South Korea / NCT06099366
Recruiting Phase 2

Treatment of Newly Diagnosed Standard Risk Acute Lymphoblastic Leukemia in Children

NCT06099366 · tracked via the Priya Life Science South Korea tracker
Sponsor
Hee Young Ju
Phase
Phase 2
Started
2024-03-05
Last updated
2026-07-29

Condition(s) studied

Lymphoblastic Leukemia in Children

Investigational drug(s) / intervention(s)

induction: vincristine, L-asparaginase, dexamethasone, intrathecal Ara-C, intrathecal MethotrexateConsolidation: Vincristine, Mecaptopurine, Intrathecal MethotrexateConsolidation: Vincristine, Mecaptopurine, Cyclophosphamide, Cytarabine, L-asparaginase, Intrathecal MethotrexateInterim Maintenance(IM): Vincristine, Methotrexate, Intrathecal MethotrexateInterim Maintenance(IM): Vincristine, Methotrexate, Mercaptopurine, Intrathecal MethotrexateDelayed Intesification(DI): Vincristine, Mercaptopurine, L-asparaginase, Doxorubicin, Cyclophosphamide, Cytarabine, Dexamethasone, Intrathecal MethotrexateDelayed Intesification(DI): Vincristine, L-asparaginase, Doxorubicin, Cyclophosphamide, Cytarabine, Dexamethasone, Intrathecal MethotrexateMaintenance: Vincristine, Mercaptopurine, Methotrexate, Dexamethasone, Intrathecal Methotrexate

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

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

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

Interim Maintenance(IM): Vincristine, Methotrexate, Intrathecal Methotrexate: Vincristine 1.5mg/m2 Methotrexate 5,000mg/m2 Intrathecal Methotrexate

Interim Maintenance(IM): Vincristine, Methotrexate, Mercaptopurine, Intrathecal Methotrexate: 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: 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: 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: Vincristine 1.5mg/m2 Mercaptopurine 50mg/m2 Methotrexate 20mg/m2 Dexamethasone 6mg/m2 Intrathecal Methotrexate

Study summary

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.

Eligibility

Sex
ALL
Min age
1 Year
Max age
9 Years
Healthy volunteers
No
\<Inclusion Criteria\> * Newly diagnosed pediatric/adolescent acute lymphomblastic leukemia patient with NCL standard risk that stratifies all 1-4 of following 1. 1 year old ≤ Age \< 10 years old 2. white blood cell at initial diagnosis \< 5x10\^10/L (50,000uL) 3. No testis involvement 4. Satisfaction of following organ functions 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\> 1. Steroid administration within 2 weeks before the registration 2. t(9;22) or t(4;11)(q11;q23) or chromosome \< 44 or iAMP21 or t(17;19)/TCF3-HLF 3. Newly diagnosed T cell ALL 4. One of the following syndromes: Down syndrome, Bloom syndrome, ataxia-telangiectasia, Fanconi anemia, Kostmann syndrome, Shwachman-Diamond syndrome, or other bone marrow failure syndrome 5. Burkitt leukemia/lymphoma 6. In the presence of electrocardiographic findings suggesting uncontrolled cardiac dysfunction (e.g., unstable ischemia, symptomatic arrhythmia, congestive heart failure) or congenital long QT syndrome 7. When the clinical trial subject(or legal representative) does not consent or is unable to give written consent

Primary outcome measure(s)

  • 5-year event free survival rate — Up to 5-years

Trial sites (13)

FacilityCityRegionStatus
Asan Medical Center Seoul Other (Non U.s.) Recruiting
Samsung Medical Center Seoul Other (Non U.s.) Recruiting
Pusan National University Yangsan Hospital Yangsan Yangsan-si Recruiting
Kyungpook National University Chilgok-Hospital Daegu South Korea Not Yet Recruiting
Chungnam National University Hospital Daejeon South Korea Not Yet Recruiting
Chonnam National University Hwasun Hospital Hwasun South Korea Not Yet Recruiting
Jeju National University Hospital Jeju City South Korea Recruiting
Seoul National University Bundang Hospital Seongnam South Korea Recruiting
Korea University Anam Hospital Seoul South Korea Recruiting
Seoul National University Hospital Seoul South Korea Recruiting
Severance Hospital Seoul South Korea Recruiting
Seoul saint Mary's Hospital Seoul South Korea Recruiting
Ajou University Medical Center Suwon South Korea Recruiting
Official registry record

This page summarises publicly available registry data for informational purposes — not medical advice. Eligibility is determined by each study team; patients should discuss participation with their clinician.

View NCT06099366 on ClinicalTrials.gov ↗ ← All trials in South Korea