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NCT06099366RecruitingPhase 2

Treatment of Newly Diagnosed Standard Risk Acute Lymphoblastic Leukemia in Children

Treatment of Newly Diagnosed Standard Risk Acute Lymphoblastic Leukemia in

Source: ClinicalTrials.gov · Last updated 29 Jul 2026

Brief summary (registry, in English)

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.

Status (registry)
Recruiting
Phase (registry)
Phase 2
Study type
Interventional
Enrollment
116 (estimated)
First submitted
18 Oct 2023
Start date
5 Mar 2024
Primary completion date
31 Dec 2033
Lead sponsor
Hee Young Ju
NCT number
NCT06099366

What you commit to

  • Study type: Interventional · Phase 2
  • Planned participants: 116
  • From 5 Mar 2024 to the primary completion date, 31 Dec 2033
  • 13 sites in 1 country
  • Visits and tests: ask the trial team, the registry does not list them

Built from the registry fields of ClinicalTrials.gov. It describes the study, not your situation.

Who cannot take part

Copied verbatim from ClinicalTrials.gov and grouped by topic. Only the trial team decides who can take part.

Criteria the registry did not label

  • \<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
  • 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.
  • 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

Age in the registry: 1 year to 9 years · Sex: All · Does not accept healthy volunteers

Full criteria on ClinicalTrials.gov

Sites (13)

Sites in registry order. Pick your city on the disease page to sort them by distance.

SiteCityCountrySite status
Kyungpook National University Chilgok Hospital
Coordinator of this site? Confirm its status
DaeguSouth KoreaNot yet recruiting
Chungnam National University Hospital
Coordinator of this site? Confirm its status
DaejeonSouth KoreaNot yet recruiting
Chonnam National University Hwasun Hospital
Coordinator of this site? Confirm its status
HwasunSouth KoreaNot yet recruiting
Jeju National University Hospital
Coordinator of this site? Confirm its status
Jeju CitySouth KoreaRecruiting
Seoul National University Bundang Hospital
Coordinator of this site? Confirm its status
SeongnamSouth KoreaRecruiting
Seoul saint Mary's Hospital
Coordinator of this site? Confirm its status
SeoulSouth KoreaRecruiting
Samsung Medical Center
Coordinator of this site? Confirm its status
SeoulSouth KoreaRecruiting
Asan Medical Center
Coordinator of this site? Confirm its status
SeoulSouth KoreaRecruiting
Korea University Anam Hospital
Coordinator of this site? Confirm its status
SeoulSouth KoreaRecruiting
Severance hospital
Coordinator of this site? Confirm its status
SeoulSouth KoreaRecruiting
Seoul National University Hospital
Coordinator of this site? Confirm its status
SeoulSouth KoreaRecruiting
Ajou University Medical Center
Coordinator of this site? Confirm its status
SuwonSouth KoreaRecruiting
Pusan National University Yangsan Hospital
Coordinator of this site? Confirm its status
YangsanSouth KoreaRecruiting

This page is information, not medical advice. Discuss any trial with your doctor.