Treatment for high-risk pediatric leukemia
Treatment of Newly Diagnosed High Risk Pediatric Acute Lymphoblastic Leukemia-prospective, Nationwide, Multi-center Study
PHASE2 · Seoul St. Mary's Hospital · NCT06184009
This study is testing a personalized chemotherapy plan for children with high-risk leukemia to see if it can improve their treatment outcomes based on their disease levels.
Quick facts
| Phase | PHASE2 |
|---|---|
| Study type | Interventional |
| Enrollment | 370 (estimated) |
| Ages | 1 Year to 19 Years |
| Sex | All |
| Sponsor | Seoul St. Mary's Hospital (other) |
| Drugs / interventions | chemotherapy |
| Locations | 7 sites (Seoul, Seoul and 6 other locations) |
| Trial ID | NCT06184009 on ClinicalTrials.gov |
What this trial studies
This clinical trial focuses on treating newly diagnosed high-risk pediatric acute lymphoblastic leukemia (ALL) using a tailored chemotherapy regimen based on minimal residual disease (MRD) levels. Patients will undergo induction and consolidation phases, with treatment adjustments made according to their MRD status after these phases. The study aims to optimize treatment strategies for different subtypes of ALL, including T-cell and Pre-B cell types, to improve patient outcomes.
Who should consider this trial
Good fit: Ideal candidates are children and adolescents aged 1 to 19 years newly diagnosed with high-risk Pre-B acute lymphoblastic leukemia.
Not a fit: Patients with low-risk leukemia or those diagnosed outside the specified age range may not benefit from this study.
Why it matters
Potential benefit: If successful, this treatment approach could significantly improve survival rates and reduce relapse in high-risk pediatric leukemia patients.
How similar studies have performed: Other studies have shown promising results with tailored chemotherapy regimens for high-risk pediatric leukemia, indicating potential for success in this approach.
Eligibility criteria
Show full inclusion / exclusion criteria
\<Inclusion Criteria\> * Age: 1year\~19years of age at diagnosis * Patients who are newly diagnosed Pre-B ALL and meet one of the following criteria * High-risk group according to the National Cancer Institute (NCI)/Rome: Age greater than or equal to 10 years and less than 19 years at diagnosis, or white blood cell count greater than or equal to 50 x 10\^9/L at diagnosis * If extra-bone marrow lesions are identified at the time of diagnosis, Central nervous system involvement (CNS3) or testicular involvement * High-risk gene variants: KMT2A rearrangement intrachromosomal amplification of chromosome 21 (iAMP21) ● If subjects are under the age of 10 at the time of diagnosis and took steroids for more than 24 hours within two weeks before the diagnosis, the risk group will be determined by the presence of a whole blood test within three days before starting steroids. If a whole blood test is performed within three days before beginning steroids, the risk group will be assessed based on the white blood cell count in the test. If there is no whole blood test before starting steroids, subjects are classified as a high-risk group. If subjects are ten or older at diagnosis, pre-diagnosis steroid treatment will not affect the risk classification. * Newly diagnosed T cell ALL \<Exclusion Criteria\> * Patients with Burkitt leukemia/lymphoma or mature B-cell leukemia * Patients with Down syndrome * potential of pregnancy or during pregnancy (patients of childbearing age need adequate contraception for the duration of the trial) * Patients who have already received steroid treatment for newly diagnosed ALL specified in the above selection criteria or chemotherapies more than one intrathecal cytarabine treatment * Participating in an interventional clinical trial other than this research
Where this trial is running
Seoul, Seoul and 6 other locations
- Seoul National University Hospital — Seoul, Seoul, South Korea (RECRUITING)
- Samsung Medical Center — Seoul, Seoul, South Korea (RECRUITING)
- Korea University Anam Hospital — Seoul, South Korea (NOT_YET_RECRUITING)
- Severance Hospital — Seoul, South Korea (RECRUITING)
- Asan Medical Center — Seoul, South Korea (RECRUITING)
- Seoul saint Mary's Hospital — Seoul, South Korea (RECRUITING)
- Pusan National University Yangsan Hospital — Yangsan, South Korea (RECRUITING)
Study contacts
- Study coordinator: Jae Wook Lee, Ph.D
- Email: dashwood@catholic.ac.kr
- Phone: 82-2-2258-6192
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.
Conditions: Pediatric Acute Lymphoblastic Leukemia, HR ALL, NGS-MRD