NCT06184009RecruitingPhase 2
Treatment of Newly Diagnosed High Risk Pediatric Acute Lymphoblastic Leukemia
Treatment of Newly Diagnosed High Risk Pediatric Acute Lymphoblastic Leukemia-prospective, Nationwide, Multi-center Study
Source: ClinicalTrials.gov · Last updated 29 Jul 2026
Brief summary (registry, in English)
* Clinical and genetic factors consistent with High risk : Induction → Consolidation 1. BM MRD \< 0.01% : IM #1 → DI #1 → IM #2 → Maintenance 2. BM MRD ≥ 0.01% : IM #1 → DI #1 → IM #2 → DI #2 → Maintenance 3. BM MRD ≥ 0.01% after Consolidation <!-- --> 1. T cell ALL : Change to very high risk regimen 2. Pre-B ALL : IM #1 → Intensification 1. BM MRD \< 0.01% after IM #1 : DI #1 → IM #2 → DI #2 → Maintenance 2. BM MRD ≥ 0.01% after IM #1 : Change to Very high risk regimen * Difference in the number of \'interim maintenance(IM)\' and \'delayed intensification(DI)\' is important for chemotherapies based on MRD.
- Status (registry)
- Recruiting
- Phase (registry)
- Phase 2
- Study type
- Interventional
- Enrollment
- 370 (estimated)
- First submitted
- 5 Dec 2023
- Start date
- 10 Aug 2024
- Primary completion date
- 31 Dec 2030
- Lead sponsor
- Jae Wook Lee
- NCT number
- NCT06184009
What you commit to
- Study type: Interventional · Phase 2
- Planned participants: 370
- From 10 Aug 2024 to the primary completion date, 31 Dec 2030
- 9 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\>
- Age: 1year\~19years of age at diagnosis
- Patients who are newly diagnosed Pre-B ALL and meet one of the following criteria
- High-risk group according to the National Cancer Institute (NCI)/Rome: Age greater than or equal to 10 years and less than 19 years at diagnosis, or white blood cell count greater than or equal to 50 x 10\^9/L at diagnosis
- If extra-bone marrow lesions are identified at the time of diagnosis, Central nervous system involvement (CNS3) or testicular involvement
- High-risk gene variants:
- KMT2A rearrangement intrachromosomal amplification of chromosome 21 (iAMP21)
- ● If subjects are under the age of 10 at the time of diagnosis and took steroids for more than 24 hours within two weeks before the diagnosis, the risk group will be determined by the presence of a whole blood test within three days before starting steroids. If a whole blood test is performed within three days before beginning steroids, the risk group will be assessed based on the white blood cell count in the test. If there is no whole blood test before starting steroids, subjects are classified as a high-risk group. If subjects are ten or older at diagnosis, pre-diagnosis steroid treatment will not affect the risk classification.
- Newly diagnosed T cell ALL
- \<Exclusion Criteria\>
- Patients with Burkitt leukemia/lymphoma or mature B-cell leukemia
- Patients with Down syndrome
- potential of pregnancy or during pregnancy (patients of childbearing age need adequate contraception for the duration of the trial)
- Patients who have already received steroid treatment for newly diagnosed ALL specified in the above selection criteria or chemotherapies more than one intrathecal cytarabine treatment
- Participating in an interventional clinical trial other than this research
Age in the registry: 1 year to 19 years · Sex: All · Does not accept healthy volunteers
Sites (9)
Sites in registry order. Save your city in your profile to sort them by distance.
| Site | City | Country | Site status |
|---|---|---|---|
| Inha University Hospital Coordinator of this site? Confirm its status | Incheon | South Korea | Not yet 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 | Not yet recruiting |
| Severance 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 |
| Seoul saint Mary's 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 Hospital 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.