New treatment for children with standard risk acute lymphoblastic leukemia
Treatment of Newly Diagnosed Standard Risk Acute Lymphoblastic Leukemia in
This study is testing a new treatment plan for children with standard risk acute lymphoblastic leukemia to see if using genetic testing can help improve their chances of recovery.
Quick facts
| Phase | Phase 2 |
|---|---|
| Study type | Interventional |
| Enrollment | 116 (estimated) |
| Ages | 1 Year to 9 Years |
| Sex | All |
| Sponsor | Samsung Medical Center Academic / other |
| Locations | 9 sites (Seoul, Other (Non U.s.) and 8 other locations) |
| Trial ID | NCT06099366 on ClinicalTrials.gov |
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.
Who should consider this trial
Good fit: Ideal candidates are children and adolescents aged 1 to less than 10 years with newly diagnosed standard risk acute lymphoblastic leukemia.
Not a fit: Patients with high-risk features or those outside the specified age range may not benefit from this study.
Why it matters
Potential benefit: If successful, this approach could lead to improved treatment outcomes and reduced relapse rates for children with acute lymphoblastic leukemia.
How similar studies have performed: Other studies utilizing risk-stratified treatment approaches in pediatric leukemia have shown promising results, suggesting potential for success in this trial as well.
Eligibility criteria
Show full inclusion / exclusion criteria
\<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 this trial is running
Seoul, Other (Non U.s.) and 8 other locations
- 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)
- Chonnam National University Hwasun Hospital — Hwasun, South Korea (Not_yet_recruiting)
- Jeju National University Hospital — Jeju City, South Korea (Not_yet_recruiting)
- Korea University Anam Hospital — Seoul, South Korea (Not_yet_recruiting)
- Seoul National University Hospital — Seoul, South Korea (Recruiting)
- Severance Hospital — Seoul, South Korea (Recruiting)
- Seoul saint Mary's Hospital — Seoul, South Korea (Recruiting)
Study contacts
- Study coordinator: Hee Young Ju, MD, Phd
- Email: heeyoung.ju@samsung.com
- Phone: 82-2-3410-0865
How to participate
- Review the eligibility criteria above with your treating physician.
- Visit the official trial page on ClinicalTrials.gov for the most current contact information and recruitment status.
- Contact the listed study coordinator or principal investigator to request pre-screening. Pre-screening is free and never obligates you to enroll.