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
Sites (13)
Sites in registry order. Pick your city on the disease page to sort them by distance.
| Site | City | Country | Site status |
|---|---|---|---|
| Kyungpook National University Chilgok Hospital Coordinator of this site? Confirm its status | Daegu | South Korea | Not yet recruiting |
| Chungnam National University Hospital Coordinator of this site? Confirm its status | Daejeon | South Korea | Not yet recruiting |
| Chonnam National University Hwasun Hospital Coordinator of this site? Confirm its status | Hwasun | South Korea | Not yet recruiting |
| Jeju National University Hospital Coordinator of this site? Confirm its status | Jeju City | South Korea | Recruiting |
| Seoul National University Bundang Hospital Coordinator of this site? Confirm its status | Seongnam | South Korea | Recruiting |
| Seoul saint Mary's Hospital Coordinator of this site? Confirm its status | Seoul | South Korea | Recruiting |
| Samsung Medical Center Coordinator of this site? Confirm its status | Seoul | South Korea | Recruiting |
| Asan Medical Center Coordinator of this site? Confirm its status | Seoul | South Korea | Recruiting |
| Korea University Anam Hospital Coordinator of this site? Confirm its status | Seoul | South Korea | Recruiting |
| Severance hospital Coordinator of this site? Confirm its status | Seoul | South Korea | Recruiting |
| Seoul National University Hospital Coordinator of this site? Confirm its status | Seoul | South Korea | Recruiting |
| Ajou University Medical Center Coordinator of this site? Confirm its status | Suwon | South Korea | Recruiting |
| Pusan National University Yangsan Hospital Coordinator of this site? Confirm its status | Yangsan | South Korea | Recruiting |
This page is information, not medical advice. Discuss any trial with your doctor.