Treatment plan for children and teens with very high-risk acute lymphoblastic leukemia in Korea
Multi-center Clinical Trial for Optimal Treatment of Pediatric Very High-risk Acute Lymphoblastic Leukemia in Korea
This phase 2 trial tests using dasatinib for Philadelphia chromosome–positive patients and MRD-guided use of blinatumomab or high‑dose chemotherapy (with possible stem cell transplant) in children and adolescents (1–19) with very high‑risk ALL.
Quick facts
| Phase | Phase 2 |
|---|---|
| Study type | Interventional |
| Enrollment | 74 (estimated) |
| Ages | 1 Year to 19 Years |
| Sex | All |
| Sponsor | Seoul National University Hospital Academic / other |
| Drugs / interventions | Blinatumomab, Dasatinib, Methotrexate |
| Locations | 6 sites (Seoul and 5 other locations) |
| Trial ID | NCT06257394 on ClinicalTrials.gov |
What this trial studies
This multi-center phase 2 protocol assigns patients to two arms according to Philadelphia chromosome status, giving dasatinib alongside standard therapy for Ph+ patients and standard non‑dasatinib regimens for other very high‑risk cases. Treatment decisions after induction and consolidation are guided by sensitive NGS‑MRD and qPCR results: patients with persistent MRD receive blinatumomab and are considered for allogeneic hematopoietic stem cell transplantation, while MRD‑negative patients proceed to intensified chemotherapy and maintenance. Reinduction is used for patients with M2/M3 marrow after induction, followed by MRD‑directed consolidation and transplant when indicated. The trial is being run at major tertiary hospitals in Seoul and focuses on reducing relapse and optimizing timing of targeted therapy and transplant in pediatric VHR ALL.
Who should consider this trial
Good fit: Children and adolescents aged 1–19 with very high‑risk ALL features such as Philadelphia chromosome t(9;22), failed remission (blast >5% after induction), hypodiploidy (<44 chromosomes), E2A‑HLF translocation, or persistent NGS‑MRD ≥0.01% as defined in the protocol are eligible.
Not a fit: Patients without the listed very high‑risk features, those with contraindications to the study medications, or those unable to undergo MRD monitoring or required hospital treatments are unlikely to benefit from this protocol.
Why it matters
Potential benefit: If successful, this approach could lower relapse rates and improve survival by using targeted therapy and MRD‑guided decisions to tailor consolidation and transplant for very high‑risk pediatric ALL.
How similar studies have performed: Other trials have shown that dasatinib improves outcomes in Ph+ ALL and that blinatumomab can clear MRD and reduce relapse risk, but combining MRD‑guided blinatumomab use with this specific protocol in a Korean pediatric VHR population is relatively novel.
Eligibility criteria
Show full inclusion / exclusion criteria
Inclusion Criteria: * Pediatric patients diagnosed with ALL between the ages of 1 and 19 years at the time of diagnosis who meet one or more of the following conditions: * Philadelphia chromosome-positive t(9;22)(q34;q11) or * Patients with failed remission who had blast \> 5% on bone marrow test after initial remission induction therapy or * Hypodiploidy (Number of chromosomes \< 44 (less than 44)) or * E2A-HLF(Hepatic Leukemia Factor) translocation-positive or * When the prognosis is judged to be poor according to NGS-MRD results among high-risk ALL patients (i) In B-ALL, the NGS-MRD(Next Generation Sequencing-Minimal Residual Disease) after consolidation therapy is 0.01% or more, and the NGS-MRD followed during interim maintenance treatment is also 0.01% or more, (ii) In T-ALL, NGS-MRD(Next Generation Sequencing-Minimal Residual Disease) is more than 0.01% after consolidation therapy Exclusion Criteria: * Participants with contraindications to medications * When the study participant or their legal representative withdraws consent * Pregnant or lactating women (patients of child-bearing potential require adequate contraception during the study period) * Participants who are medically unsuitable to participate in this study at the discretion of the investigator Participants participating in other interventional studies other than this protocol
Where this trial is running
Seoul and 5 other locations
- Seoul National University Hospital — Seoul, South Korea (Recruiting)
- Severance Hospital — Seoul, South Korea (Recruiting)
- Asan Medical Center — Seoul, South Korea (Recruiting)
- Samsung Medical Center — Seoul, South Korea (Recruiting)
- Seoul saint Mary's Hospital — Seoul, South Korea (Recruiting)
- Pusan National University Yangsan Hospital — Yangsan, South Korea (Not_yet_recruiting)
Study contacts
- Study coordinator: Hyoung Jin Kang, Ph.D
- Email: kanghj@snu.ac.kr
- Phone: +82-2-2072-3452
How to participate
- Review the eligibility criteria above with your treating physician.
- Visit the official trial page on ClinicalTrials.gov for the most current contact information and recruitment status.
- Contact the listed study coordinator or principal investigator to request pre-screening. Pre-screening is free and never obligates you to enroll.