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Personalized chemo dosing may boost leukemia remission in kids

NCT ID NCT06099366

Cure Sponsor: Hee Young Ju Source: ClinicalTrials.gov ↗

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 Results may not be published yet.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This status has not been confirmed recently, so it may be out of date.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 trial tests whether using advanced genetic testing (NGS) to measure leftover cancer cells after initial treatment can help doctors tailor chemotherapy for children with standard-risk acute lymphoblastic leukemia. Around 116 children aged 1 to 10 will receive a standard chemotherapy regimen, but those with detectable cancer cells after induction may get more intensive treatment. The goal is to see if this personalized approach improves the five-year survival rate without relapse.

What this could mean

Our plain-language read of the trial. This is informational only, not medical advice or a prediction.

Active substance
a combination of chemotherapy drugs (vincristine, L-asparaginase, dexamethasone, methotrexate, cytarabine, cyclophosphamide, mercaptopurine) with doses guided by genetic testing
What this could lead to
If successful, this approach could increase the chance of long-term remission and reduce relapse in children with leukemia.
What could go wrong
This is a Phase 2 trial, so the approach is still being tested. Chemotherapy carries risks like infection, nerve damage, and organ toxicity.

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 116 people

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

Started

Mar 2024

Expected to finish

Dec 2033

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 9 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\> * 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

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Conditions

The condition(s) this trial relates to.

acute lymphoblastic leukemia B-cell acute lymphoblastic leukemia childhood acute lymphoblastic leukemia

As listed by the trial registrant

The condition terms exactly as the trial's registrant entered them.

Lymphoblastic leukemia in children

How to take part

Only the study team decides who joins. These are the ways to reach them.

  1. The places running it

    13 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 Medical Center

    RECRUITING

    Suwon, 16499, South Korea

  • Asan Medical Center

    RECRUITING

    Seoul, Other (Non U.s.), 03174, South Korea

  • Chonnam National University Hwasun Hospital

    NOT_YET_RECRUITING

    Hwasun, 58128, South Korea

  • Chungnam National University Hospital

    NOT_YET_RECRUITING

    Daejeon, 35015, South Korea

  • Jeju National University Hospital

    RECRUITING

    Jeju City, 63241, South Korea

  • Korea University Anam Hospital

    RECRUITING

    Seoul, 02841, South Korea

  • Kyungpook National University Chilgok-Hospital

    NOT_YET_RECRUITING

    Daegu, 41404, South Korea

  • Pusan National University Yangsan Hospital

    RECRUITING

    Yangsan, Yangsan-si, 50612, South Korea

  • Samsung Medical Center

    RECRUITING

    Seoul, Other (Non U.s.), 03174, South Korea

  • Seoul National University Bundang Hospital

    RECRUITING

    Seongnam, 13620, South Korea

  • Seoul National University Hospital

    RECRUITING

    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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