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RecruitingPhase 2NCT06099366

Treatment of Newly Diagnosed Standard Risk Acute Lymphoblastic Leukemia in Children

Treatment of Newly Diagnosed Standard Risk Acute Lymphoblastic Leukemia in

Sponsor

Hee Young Ju

Enrollment

116 participants

Start Date

Mar 5, 2024

Study Type

INTERVENTIONAL

Conditions

Lymphoblastic Leukemia in Children

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

Min Age: 1 YearMax Age: 9 Years

Inclusion Criteria8

  • Newly diagnosed pediatric/adolescent acute lymphomblastic leukemia patient with NCL standard risk that stratifies all 1-4 of following
  • year old ≤ Age \< 10 years old
  • white blood cell at initial diagnosis \< 5x10\^10/L (50,000uL)
  • No testis involvement
  • 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:
  • 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 Criteria7

  • Steroid administration within 2 weeks before the registration
  • t(9;22) or t(4;11)(q11;q23) or chromosome \< 44 or iAMP21 or t(17;19)/TCF3-HLF
  • Newly diagnosed T cell ALL
  • One of the following syndromes: Down syndrome, Bloom syndrome, ataxia-telangiectasia, Fanconi anemia, Kostmann syndrome, Shwachman-Diamond syndrome, or other bone marrow failure syndrome
  • Burkitt leukemia/lymphoma
  • In the presence of electrocardiographic findings suggesting uncontrolled cardiac dysfunction (e.g., unstable ischemia, symptomatic arrhythmia, congestive heart failure) or congenital long QT syndrome
  • When the clinical trial subject(or legal representative) does not consent or is unable to give written consent

Interventions

DRUGinduction: 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

DRUGConsolidation: 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

DRUGConsolidation: 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

DRUGInterim Maintenance(IM): Vincristine, Methotrexate, Intrathecal Methotrexate

Vincristine 1.5mg/m2 Methotrexate 5,000mg/m2 Intrathecal Methotrexate

DRUGInterim Maintenance(IM): Vincristine, Methotrexate, Mercaptopurine, Intrathecal Methotrexate

Vincristine 1.5mg/m2 Methotrexate 5,000mg/m2 Mecaptopurine: 25mg/m2 Intrathecal Methotrexate

DRUGDelayed 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

DRUGDelayed 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

DRUGMaintenance: Vincristine, Mercaptopurine, Methotrexate, Dexamethasone, Intrathecal Methotrexate

Vincristine 1.5mg/m2 Mercaptopurine 50mg/m2 Methotrexate 20mg/m2 Dexamethasone 6mg/m2 Intrathecal Methotrexate

Locations(9)

Asan Medical Center

Seoul, Other (Non U.s.), South Korea

Samsung Medical Center

Seoul, Other (Non U.s.), South Korea

Pusan National University Yangsan Hospital

Yangsan, Yangsan-si, South Korea

Chonnam National University Hwasun Hospital

Hwasun, South Korea

Jeju National University Hospital

Jeju City, South Korea

Korea University Anam Hospital

Seoul, South Korea

Seoul National University Hospital

Seoul, South Korea

Severance Hospital

Seoul, South Korea

Seoul saint Mary's Hospital

Seoul, South Korea

View Full Details on ClinicalTrials.gov

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NCT06099366

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