Treatment plan for children and teens with very high-risk acute lymphoblastic leukemia in Korea

Is this trial a fit for you?

A plain-English reading of the study's rules. Only the study team can confirm whether you qualify.

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.

Why it matters

Who can join: the full rules

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 it's running

• Kyungpook National University Chilgok-Hospital
  Daegu, South Korea Recruiting
• Chungnam National University Hospital
  Daejeon, South Korea Recruiting
• Chonnam National University Hwasun Hospital
  Hwasun, South Korea Recruiting
• Jeju National University Hospital
  Jeju City, South Korea Recruiting
• Seoul National University Hospital
  Seoul, South Korea Recruiting
• Severance Hospital
  Seoul, South Korea Recruiting

Study contacts

• Study coordinator: Hyoung Jin Kang, Ph.D
• Email: kanghj@snu.ac.kr
• Phone: +82-2-2072-3452

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How to take part

1. Review the eligibility criteria above with your treating physician.
2. Check the official listing on ClinicalTrials.gov for the latest contact details and recruitment status.
3. Contact the study coordinator or principal investigator to ask for pre-screening. Pre-screening is free and never obligates you to enroll.