Status:
RECRUITING
Treatment of Newly Diagnosed Standard Risk Acute Lymphoblastic Leukemia in Children
Lead Sponsor:
Hee Young Ju
Collaborating Sponsors:
Asan Medical Center
Seoul National University Hospital
Conditions:
Lymphoblastic Leukemia in Children
Eligibility:
All Genders
1-9 years
Phase:
PHASE2
Brief Summary
Aim of this study is to investigate the outcome of NGS MRD based risk stratified treatment for high risk acute lymphoblastic leukemia in children and adolescents.
Eligibility Criteria
Inclusion
- \<Inclusion Criteria\>
- Newly diagnosed pediatric/adolescent acute lymphomblastic leukemia patient with NCL standard risk that stratifies all 1-4 of following
- 1 year old ≤ Age \< 10 years old
- white blood cell at initial diagnosis \< 5x10\^10/L (50,000uL)
- No testis involvement
- Satisfaction of following organ functions
- A. Kidney function (satisfies i or ii) i. Creatinine clearance (or radioisotope-measured GFR) ≥ 70mL/min/1.73m2 ii. Creatinine value according to age/sec satisfies the following:
- 1 to \< 2 years: Male: 0.6 / Female: 0.6, 2 to \< 6 years: Male: 0.8 / Female: 0.8, 6 to \< 10 years: Male: 1 / Female: 1, 10 to \< 13 years: Male: 1.2 / Female: 1.2, 13 to \< 16 years: Male: 1.5 / Female: 1.4, ≥ 16 years: Male: 1.7 / Female: 1.4 However, subjects who meet the selection criteria within 1 week before registration after receiving appropriate conservative treatment, including fluid therapy, can be registered.
- B. Liver function i. Direct bilirubin \< 3.0mg/dL
- \<Exclusion Criteria\>
- Steroid administration within 2 weeks before the registration
- t(9;22) or t(4;11)(q11;q23) or chromosome \< 44 or iAMP21 or t(17;19)/TCF3-HLF
- Newly diagnosed T cell ALL
- One of the following syndromes: Down syndrome, Bloom syndrome, ataxia-telangiectasia, Fanconi anemia, Kostmann syndrome, Shwachman-Diamond syndrome, or other bone marrow failure syndrome
- Burkitt leukemia/lymphoma
- In the presence of electrocardiographic findings suggesting uncontrolled cardiac dysfunction (e.g., unstable ischemia, symptomatic arrhythmia, congestive heart failure) or congenital long QT syndrome
- When the clinical trial subject(or legal representative) does not consent or is unable to give written consent
Exclusion
Key Trial Info
Start Date :
March 5 2024
Trial Type :
INTERVENTIONAL
Allocation :
ESTIMATED
End Date :
December 31 2033
Estimated Enrollment :
116 Patients enrolled
Trial Details
Trial ID
NCT06099366
Start Date
March 5 2024
End Date
December 31 2033
Last Update
June 8 2025
Active Locations (9)
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1
Asan Medical Center
Seoul, Other (Non U.s.), South Korea, 03174
2
Samsung Medical Center
Seoul, Other (Non U.s.), South Korea, 03174
3
Pusan National University Yangsan Hospital
Yangsan, Yangsan-si, South Korea, 50612
4
Chonnam National University Hwasun Hospital
Hwasun, South Korea, 58128