Personalized chemo dosing may boost survival in kids with High-Risk leukemia
NCT ID NCT06184009
First seen Jul 29, 2026 · Last updated Jul 30, 2026 · Updated 1 time
Summary
This nationwide trial is testing whether adjusting chemotherapy intensity based on the amount of leukemia cells remaining after initial treatment (called minimal residual disease, or MRD) can improve outcomes for children and teens with high-risk acute lymphoblastic leukemia (ALL). Participants receive different numbers of chemotherapy cycles depending on their MRD levels, with the goal of increasing cure rates while minimizing unnecessary toxicity. The study enrolls newly diagnosed patients aged 1 to 19 who meet high-risk criteria.
What this could mean
Our plain-language read of the trial. This is informational only, not medical advice or a prediction.
- Active substance
- chemotherapy regimen adjusted by minimal residual disease (MRD) levels
- What this could lead to
- If successful, this approach could improve long-term survival and reduce relapse in children with high-risk ALL, potentially curing more patients.
- What could go wrong
- This is a Phase 2 trial, so the strategy is still being tested. Chemotherapy carries significant side effects, and the benefit of MRD-guided adjustments is not yet proven.
This is an AI summary of the original study and may miss details. Read our disclaimer.
Study facts
What this study's own registry entry says, in plain language.
- Phase
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Phase 2
Tests whether the treatment actually works, and watches for side effects, in a larger group.
- Participants
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About 370 people
The number the study aims to enrol. It can still change while the study runs.
- Started
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Aug 2024
- Expected to finish
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Dec 2030
An estimate. End dates often move.
- Lead sponsor
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Other sponsor
The registry's catch-all category, for sponsors it does not file as a company, a government agency, or a research network.
Who can take part
This study's own entry requirements. Only the study team can say for certain whether you qualify.
- Ages
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1 year to 19 years
- Sex
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Anyone
- Healthy volunteers
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Not accepted
This study is not open to healthy volunteers. The entry requirements below say who it is open to.
Show the full entry requirements Hide the full entry requirements
Copied word for word from the study's registry entry, so the wording is the study team's rather than ours.
\<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
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Conditions
The condition(s) this trial relates to.
As listed by the trial registrant
The condition terms exactly as the trial's registrant entered them.
How to take part
Only the study team decides who joins. These are the ways to reach them.
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The places running it
9 sites. The list below names each one and where it is.
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The official record
ClinicalTrials.gov lists the study team's own contact details, including names and phone numbers. We don't republish those.
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A doctor treating you
A doctor who knows your case can contact a study site on your behalf, and can tell you whether this study is worth pursuing at all.
Contacts and locations
Locations
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Ajou University Hospital
RECRUITINGSuwon, 16499, South Korea
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Asan Medical Center
RECRUITINGSeoul, 05505, South Korea
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Inha University Hospital
NOT_YET_RECRUITINGIncheon, 22332, South Korea
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Korea University Anam Hospital
NOT_YET_RECRUITINGSeoul, 02841, South Korea
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Pusan National University Yangsan Hospital
RECRUITINGYangsan, 50612, South Korea
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Samsung Medical Center
RECRUITINGSeoul, Seoul, South Korea
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Seoul National University Hospital
RECRUITINGSeoul, Seoul, 03080, South Korea
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Seoul saint Mary's Hospital
RECRUITINGSeoul, 06591, South Korea
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Severance Hospital
RECRUITINGSeoul, 03722, South Korea
More trials for these conditions
Other studies related to the condition(s) this trial covers.
- A pill after transplant: new hope to stop t-cell cancer relapse
- Can a cheaper copy of a leukemia drug work just as well?
- Engineered immune cells take aim at Hard-to-Treat T-Cell cancers
- Engineered immune cells take aim at stubborn blood cancers
- Double-Barreled immune attack aims to wipe out T-ALL
- Chemotherapy showdown: which combo works best for T-Cell cancers in kids?