Actively Recruiting
Multi-center Clinical Trial for Optimal Treatment of Pediatric Very High-risk Acute Lymphoblastic Leukemia in Korea
Led by Hyoung Jin Kang · Updated on 2025-06-08
74
Participants Needed
6
Research Sites
N/A
Total Duration
On this page
Sponsors
H
Hyoung Jin Kang
Lead Sponsor
A
Asan Medical Center
Collaborating Sponsor
AI-Summary
What this Trial Is About
This trial focuses on pediatric patients with very high-risk acute lymphoblastic leukemia (ALL), including those with Philadelphia chromosome-positive ALL and other high-risk types. The study aims to evaluate optimal treatment strategies for these patients, comparing different treatment approaches based on genetic and disease response markers. It is a phase 2, multi-center clinical trial led by Hyoung Jin Kang in Korea. Participants are assigned to one of two treatment groups: Arm A for Philadelphia chromosome-positive ALL, which involves induction therapy with Dasatinib and chemotherapy, followed by consolidation and maintenance phases tailored by disease response. Arm B includes patients with other very high-risk ALL types receiving induction chemotherapy followed by consolidation and possible stem cell transplantation. Treatments include High Dose Methotrexate, Cytarabine, Blinatumomab, and allogeneic hematopoietic stem cell transplantation depending on response and minimal residual disease status. Throughout the study, participants undergo various phases including induction, consolidation, delayed intensification, interim maintenance, and maintenance therapy lasting up to several years. Researchers monitor event-free survival, overall survival, relapse rates, adverse events, and transplant rates for up to five years. Safety is tracked from the first day of treatment to 28 days after the last drug dose. The total duration of participation and detailed treatment schedules vary per patient based on their response to therapies.
CONDITIONS
Brief Title
Treatment of Pediatric Very High-risk Acute Lymphoblastic Leukemia in Korea
Who Can Participate
Eligibility Criteria
You may qualify if you...
- Pediatric patients aged 1 to 19 years at diagnosis
- Diagnosed with acute lymphoblastic leukemia (ALL)
- Presence of Philadelphia chromosome-positive t(9;22)(q34;q11) or
- Failed remission with more than 5% blasts after initial remission induction therapy or
- Hypodiploidy with fewer than 44 chromosomes or
- E2A-HLF (Hepatic Leukemia Factor) translocation-positive or
- Poor prognosis based on NGS-MRD results after consolidation therapy in B-ALL or T-ALL according to specified thresholds
You will not qualify if you...
- Contraindications to study medications
- Withdrawal of consent by participant or legal representative
- Pregnant or lactating women; patients of child-bearing potential must use contraception during the study
- Medically unsuitable for participation as determined by investigator
- Participation in other interventional studies outside this protocol
AI-Screening
AI-Powered Screening
Complete this quick 3-step screening to check your eligibility
Your Study Journey
Duration - 2 to 4 weeks
Participants are screened for eligibility to participate in the trial.
1 visit (in-person)
Duration - Varies according to treatment response and consolidation regimen
Participants receive induction therapy followed by consolidation phases. Depending on response and minimal residual disease (MRD) status, participants may receive different consolidation treatments including high dose chemotherapy, Blinatumomab, and Dasatinib (for Arm A). Some participants may undergo re-induction or proceed to hematopoietic stem cell transplantation (HSCT).
Multiple visits for induction and consolidation phases with treatment administration
Duration - Up to 5 years
Participants are followed for up to 5 years to monitor event-free survival, overall survival, recurrence, adverse events, and transplant outcomes.
Regular follow-up visits over several years
Trial Site Locations
Total: 6 locations
1
Seoul National University Hospital
Seoul, South Korea, 03080
Actively Recruiting
2
Severance Hospital
Seoul, South Korea, 03722
Actively Recruiting
3
Asan Medical Center
Seoul, South Korea, 05505
Actively Recruiting
4
Samsung Medical Center
Seoul, South Korea, 06351
Actively Recruiting
5
Seoul saint Mary's Hospital
Seoul, South Korea, 06591
Actively Recruiting
6
Pusan National University Yangsan Hospital
Yangsan, South Korea, 50612
Not Yet Recruiting
Research Team
H
Hyoung Jin Kang, Ph.D
H
Hyoung Jin Kang
How is the study designed?
Study Type
INTERVENTIONAL
Masking
NONE
Allocation
NON_RANDOMIZED
Model
PARALLEL
Primary Purpose
TREATMENT
Number of Arms
2
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