New treatment for children with standard risk acute lymphoblastic leukemia

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 study investigates the effectiveness of a risk-stratified treatment approach based on next-generation sequencing minimal residual disease (NGS MRD) for children and adolescents newly diagnosed with standard risk acute lymphoblastic leukemia (ALL). The treatment regimen includes various chemotherapy agents such as vincristine, L-asparaginase, and methotrexate, administered in different phases including induction, consolidation, and interim maintenance. The goal is to improve patient outcomes by tailoring therapy based on individual risk factors identified through advanced genetic testing.

Why it matters

Who can join: the full rules

\<Inclusion Criteria\>

* Newly diagnosed pediatric/adolescent acute lymphomblastic leukemia patient with NCL standard risk that stratifies all 1-4 of following

  1. 1 year old ≤ Age \< 10 years old
  2. white blood cell at initial diagnosis \< 5x10\^10/L (50,000uL)
  3. No testis involvement
  4. 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\>

1. Steroid administration within 2 weeks before the registration
2. t(9;22) or t(4;11)(q11;q23) or chromosome \< 44 or iAMP21 or t(17;19)/TCF3-HLF
3. Newly diagnosed T cell ALL
4. One of the following syndromes: Down syndrome, Bloom syndrome, ataxia-telangiectasia, Fanconi anemia, Kostmann syndrome, Shwachman-Diamond syndrome, or other bone marrow failure syndrome
5. Burkitt leukemia/lymphoma
6. In the presence of electrocardiographic findings suggesting uncontrolled cardiac dysfunction (e.g., unstable ischemia, symptomatic arrhythmia, congestive heart failure) or congenital long QT syndrome
7. When the clinical trial subject(or legal representative) does not consent or is unable to give written consent

Where it's running

• Asan Medical Center
  Seoul, Other (Non U.s.), South Korea Recruiting
• Samsung Medical Center
  Seoul, Other (Non U.s.), South Korea Recruiting
• Pusan National University Yangsan Hospital
  Yangsan, Yangsan-si, South Korea Recruiting
• Jeju National University Hospital
  Jeju City, South Korea Recruiting
• Seoul National University Bundang Hospital
  Seongnam, South Korea Recruiting
• Korea University Anam Hospital
  Seoul, South Korea Recruiting

Study contacts

• Study coordinator: Hee Young Ju, MD, Phd
• Email: heeyoung.ju@samsung.com
• Phone: 82-2-3410-0865

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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.