Actively Recruiting
Treatment of Newly Diagnosed High Risk Pediatric Acute Lymphoblastic Leukemia
Led by Jae Wook Lee · Updated on 2025-06-08
370
Participants Needed
7
Research Sites
333 weeks
Total Duration
On this page
Sponsors
J
Jae Wook Lee
Lead Sponsor
S
Samsung Medical Center
Collaborating Sponsor
AI-Summary
What this Trial Is About
* 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.
CONDITIONS
Official Title
Treatment of Newly Diagnosed High Risk Pediatric Acute Lymphoblastic Leukemia
Who Can Participate
Eligibility Criteria
You may qualify if you...
- Age between 1 and 19 years at diagnosis
- Newly diagnosed Pre-B ALL patients classified as high risk by National Cancer Institute/Rome criteria (age 10-19 years or white blood cell count ≥ 50 x 10^9/L at diagnosis)
- Patients with extra-bone marrow lesions, central nervous system involvement (CNS3), or testicular involvement at diagnosis
- Presence of high-risk gene variants such as KMT2A rearrangement or intrachromosomal amplification of chromosome 21 (iAMP21)
- Newly diagnosed T cell ALL patients
- For patients under 10 years who took steroids before diagnosis, risk classification is based on white blood cell count from blood test within three days before steroid start; if no test, classified as high risk
You will not qualify if you...
- Patients with Burkitt leukemia/lymphoma or mature B-cell leukemia
- Patients with Down syndrome
- Pregnancy or potential pregnancy without adequate contraception during the trial
- Patients who have already received steroid treatment for newly diagnosed ALL or more than one intrathecal cytarabine treatment
- Participation in any other interventional clinical trial besides this study
AI-Screening
AI-Powered Screening
Complete this quick 3-step screening to check your eligibility
Trial Site Locations
Total: 7 locations
1
Seoul National University Hospital
Seoul, Seoul, South Korea, 03080
Actively Recruiting
2
Samsung Medical Center
Seoul, Seoul, South Korea
Actively Recruiting
3
Korea University Anam Hospital
Seoul, South Korea, 02841
Not Yet Recruiting
4
Severance Hospital
Seoul, South Korea, 03722
Actively Recruiting
5
Asan Medical Center
Seoul, South Korea, 05505
Actively Recruiting
6
Seoul saint Mary's Hospital
Seoul, South Korea, 06591
Actively Recruiting
7
Pusan National University Yangsan Hospital
Yangsan, South Korea, 50612
Actively Recruiting
Research Team
J
Jae Wook Lee, Ph.D
CONTACT
How is the study designed?
Study Type
INTERVENTIONAL
Masking
NONE
Allocation
NA
Model
SINGLE_GROUP
Primary Purpose
TREATMENT
Number of Arms
1
Not the Right Trial for You?
Explore thousands of other clinical trials that might be a better match.
Sign up to get personalized trial recommendations delivered to your inbox.
Already have an account? Log in here