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Personalized chemo dosing may boost survival in kids with High-Risk leukemia

NCT ID NCT06184009

What the study statuses mean

This study's is highlighted.

Recruitment status, easiest to join first

Recruiting now This study
This trial is taking on new participants right now.
Not yet recruiting
Registered, but not yet taking participants.
By invitation only
Not open to general applications. Only people the study team invites can take part.
Paused
Paused for now. It may or may not start again.
Ongoing
Running, but no longer taking on new participants.
Completed
The trial has finished. Results may not be published yet.
Stopped early
Stopped early, before it reached the end. That can be for many reasons, including safety.
Cancelled
Cancelled before anyone took part.

Expanded access (not trials)

Expanded access
Not a trial. This treatment can be requested outside a study, case by case, for people who qualify.
Expanded access (paused)
Not a trial. The treatment can normally be requested outside a study, but is unavailable right now.
Expanded access (ended)
Not a trial. The treatment could once be requested outside a study, but no longer can.
Approved
The treatment has been approved, so it is available normally rather than through this programme.

When the status isn't known

Details not published
The full record has not been published yet, so there is little to show here.
Status unknown
This status has not been confirmed recently, so it may be out of date.

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

Phase 2

Tests whether the treatment actually works, and watches for side effects, in a larger group.

Participants

About 370 people

The number the study aims to enrol. It can still change while the study runs.

Started

Aug 2024

Expected to finish

Dec 2030

An estimate. End dates often move.

Lead sponsor

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

1 year to 19 years

Sex

Anyone

Healthy volunteers

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

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.

  1. The places running it

    9 sites. The list below names each one and where it is.

  2. The official record

    ClinicalTrials.gov lists the study team's own contact details, including names and phone numbers. We don't republish those.

    Open the record ↗

  3. 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

  • Ajou University Hospital

    RECRUITING

    Suwon, 16499, South Korea

  • Asan Medical Center

    RECRUITING

    Seoul, 05505, South Korea

  • Inha University Hospital

    NOT_YET_RECRUITING

    Incheon, 22332, South Korea

  • Korea University Anam Hospital

    NOT_YET_RECRUITING

    Seoul, 02841, South Korea

  • Pusan National University Yangsan Hospital

    RECRUITING

    Yangsan, 50612, South Korea

  • Samsung Medical Center

    RECRUITING

    Seoul, Seoul, South Korea

  • Seoul National University Hospital

    RECRUITING

    Seoul, Seoul, 03080, South Korea

  • Seoul saint Mary's Hospital

    RECRUITING

    Seoul, 06591, South Korea

  • Severance Hospital

    RECRUITING

    Seoul, 03722, South Korea

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