Treatment of Pediatric Very High-risk Acute Lymphoblastic Leukemia in Korea

Recruiting now · Phase 2

Conditions studied: Acute Lymphoblastic Leukemia, Pediatric

In brief

Very high-risk acute lymphoblastic leukemia

Key facts

Study ID

NCT06257394

Run by

Hyoung Jin Kang

People needed

74

Starts

2024-10-20

Expected to finish

2034-12-31

Last updated by the study team

2026-07-29

Who can join

Age: 1 and older, up to 19. Sex: any. Healthy volunteers: not accepted.

You may qualify if…

• 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

You may not qualify if…

• 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 is running

• Kyungpook National University Chilgok-Hospital — Daegu, South Korea (enrolling)
• Chungnam National University Hospital — Daejeon, South Korea (enrolling)
• Chonnam National University Hwasun Hospital — Hwasun, South Korea (enrolling)
• Jeju National University Hospital — Jeju City, South Korea (enrolling)
• Seoul National University Hospital — Seoul, South Korea (enrolling)
• Severance Hospital — Seoul, South Korea (enrolling)
• Asan Medical Center — Seoul, South Korea (enrolling)
• Samsung Medical Center — Seoul, South Korea (enrolling)
• Seoul saint Mary's Hospital — Seoul, South Korea (enrolling)
• Pusan National University Yangsan Hospital — Yangsan, South Korea (enrolling)

Full record on ClinicalTrials.gov

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