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Clinical Trials in South Korea / NCT06257394
Recruiting Phase 2

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

NCT06257394 · tracked via the Priya Life Science South Korea tracker
Sponsor
Hyoung Jin Kang
Phase
Phase 2
Started
2024-10-20
Last updated
2026-07-29

Condition(s) studied

Acute Lymphoblastic Leukemia, Pediatric

Investigational drug(s) / intervention(s)

Dasatinib(Sprycel) armNon-Dasatinib(Sprycel) arm

Dasatinib(Sprycel) arm: ▪ Arm A : Philadelphia chromosome-positive : Induction (Except Consolidation #3 using Blinatumomab, all administration should be given with Dasatinib.) * Morphologic CR after the Induction : Consolidation #1 → Consolidation #2 → Consolidation #3 1. If MRD \& qPCR not detected after the post-consolidation #1 : Consolidation #3 using HD MTX, HD Cytarabine → DI #1 → IM #2 → DI #2 → Maintenance 2. If MRD or qPCR positive after the post-consolidation #1 : Consolidation #3 using Blinatumomab →Allogeneic HSCT * M2 or M3 after the Induction : Re-induction → Consolidation #2 → Consolidation #3 → Allogeneic HSCT 1. If MRD \& qPCR not detected after the post-consolidation #1 : Consolidation #3 using HD MTX, HD Cytarabine 2. If MRD or qPCR positive after the post-reinduction : Consolidation #3 using Blinatumomab * In Arm A, except Consolidation #3 using Blinatumomab, all administration should be given with Dasatinib.

Non-Dasatinib(Sprycel) arm: ▪ Arm B : Other VHR ALL except Philadelphia chromosome-positive : Induction * Morphologic CR after the Induction : Consolidation #1 → Consolidation #2 → Consolidation #3 1. If MRD not detected after the post-consolidation #1 : Consolidation #3 using HD MTX, HD Cytarabine → Allogeneic HSCT 2. If MRD positive after the post-consolidation #1 : Consolidation #3 using Blinatumomab →Allogeneic HSCT * M2 or M3 after the Induction : Re-induction → Consolidation #2 → Consolidation #3‡ → Allogeneic HSCT 1. If MRD not detected after the post-consolidation #1 : Consolidation #3 using HD MTX, HD Cytarabine 2. If MRD positive after the post-reinduction : Consolidation #3 using Blinatumomab

Study summary

Very high-risk acute lymphoblastic leukemia

Eligibility

Sex
ALL
Min age
1 Year
Max age
19 Years
Healthy volunteers
No
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

Primary outcome measure(s)

  • Event free survival — Up to 5 years

Trial sites (10)

FacilityCityRegionStatus
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
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 Recruiting
Official registry record

This page summarises publicly available registry data for informational purposes — not medical advice. Eligibility is determined by each study team; patients should discuss participation with their clinician.

View NCT06257394 on ClinicalTrials.gov ↗ ← All trials in South Korea