Treatment for high-risk pediatric 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 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.

Why it matters

Who can join: the full rules

\<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 it's running

• Seoul National University Hospital
  Seoul, Seoul, South Korea Recruiting
• Samsung Medical Center
  Seoul, Seoul, South Korea Recruiting
• Severance Hospital
  Seoul, South Korea Recruiting
• Asan Medical Center
  Seoul, South Korea Recruiting
• Seoul saint Mary's Hospital
  Seoul, South Korea Recruiting
• Ajou University Hospital
  Suwon, South Korea Recruiting

Study contacts

• Study coordinator: Jae Wook Lee, Ph.D
• Email: dashwood@catholic.ac.kr
• Phone: 82-2-2258-6192

Similar studies

Other studies for the same condition or treatment. Recruiting studies are listed first.

• Comprehensive multi-omics and functional profiling to fully characterize tumors

  This project tests whether detailed multi-omics and functional testing of tumor samples can better characterize high-risk blood and solid cancers for patients at participating centers.

  Recruiting at 2 sites Azienda Ospedaliero-Universitaria di Parma · Palermo, Palermo and 1 other locations · NCT07403630

• Predicting Atrial Fibrillation with a Genetic Risk Score

  Researchers test whether a polygenic risk score can help flag people likely to have undiagnosed atrial fibrillation, alongside at-home and clinic heart monitoring.

  Recruiting at 5 sites Seoul St. Mary's Hospital · Incheon and 4 other locations · NCT07641582

• Enavogliflozin for Amyloid Cardiomyopathy

  This study tests whether Enavogliflozin helps people with amyloid cardiomyopathy and heart failure by comparing it to placebo in two treatment periods.

  Recruiting at 2 sites Phase 4 Seoul St. Mary's Hospital · Seoul and 1 other locations · NCT07240844

• Quality of life and treatment outcomes for relapsed/refractory multiple myeloma with advanced versus conventional immunotherapies.

  This will test whether advanced immuno-oncology treatments lead to different quality of life, safety, and treatment outcomes than conventional immunotherapies in adults with relapsed or refractory multiple myeloma.

  Recruiting Seoul St. Mary's Hospital · Seocho, Seoul · NCT07051850

• Comparing advanced and classical immunotherapy for lymphoma treatment

  This study is testing whether newer immunotherapy treatments for high-grade B cell lymphoma work better and are safer than traditional methods for adults who have already had treatment that didn't work.

  Recruiting at 2 sites Seoul St. Mary's Hospital · Seoul and 1 other locations · NCT06796517

• Comparing Ruxolitinib with Steroids for Chronic Graft-versus-Host Disease Treatment

  This study is testing if a new treatment combining Ruxolitinib with steroids can help people with moderate to severe chronic graft-versus-host disease feel better compared to just using steroids alone.

  Recruiting Phase 2 Seoul St. Mary's Hospital · Seoul, Banpo-daero/Seocho-gu · NCT06756061

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.