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NCT Number: NCT06099366

Treatment of Newly Diagnosed Standard Risk Acute Lymphoblastic Leukemia in Children

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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Key information

Age range

1 year–9 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 2

Primary location

Asan Medical Center, Seoul, Other (Non U.s.), South Korea

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Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

<Inclusion Criteria>

  • Newly diagnosed pediatric/adolescent acute lymphomblastic leukemia patient with NCL standard risk that stratifies all 1-4 of following
  • 1 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:

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>

  • 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

Treatment and study plan

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

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

Primary outcomes

  1. 5-year event free survival rate

    Time frame: Up to 5-years

Secondary outcomes

  1. Confirmation of the therapeutic effect of the initial treatment response

    Time frame: 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

  2. Disease prognosis-related factor

    Time frame: 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.

Study contacts

Contact information is provided by the study sponsor or research team.

Hee Young Ju, MD, Phd

CONTACT

[email protected]

82-2-3410-0865

hyunjung Shin

CONTACT

[email protected]

82-2-3410-6763

Sponsors and collaborators

Lead sponsor

Hee Young Ju

Other

Collaborators

  • Asan Medical Center
  • Chonnam National University Hospital
  • Jeju National University Hospital
  • Korea University Anam Hospital
  • Pusan National University Yangsan Hospital
  • Seoul National University Hospital
  • Seoul St. Mary's Hospital
  • Severance Hospital

Registry information

Official study title

Treatment of Newly Diagnosed Standard Risk Acute Lymphoblastic Leukemia in

Acronym: SR ALL

Important dates

Study start
2024
Primary completion
2033
Study completion
2033
First posted
Oct 25, 2023
Registry last updated
Jun 8, 2025

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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