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Personalized chemo and transplants aim to beat infant leukemia

NCT ID NCT06516679

Cure Sponsor: Yonsei University 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 Results may not be published yet.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This status has not been confirmed recently, so it may be out of date.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 phase 2 trial tests whether adjusting chemotherapy and using stem cell transplants based on each infant's genetic profile can improve survival. Infants under one year old with newly diagnosed leukemia receive a risk-stratified treatment plan. The study aims to see if this personalized approach leads to better outcomes and fewer long-term side effects.

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 (prednisolone, dexamethasone, vincristine, daunorubicin, L-asparaginase, cytarabine, etoposide, cyclophosphamide, methotrexate, 6-mercaptopurine) and hematopoietic stem cell transplantation
What this could lead to
If successful, this approach could lead to a more personalized treatment plan that improves survival for infants with leukemia while reducing unnecessary side effects.
What could go wrong
This is a relatively small, early-phase trial, so results may not apply to all infants. Chemotherapy and stem cell transplants carry serious risks, including infection and long-term health problems.

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 40 people

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

Started

Dec 2024

Expected to finish

Dec 2032

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

Up to 2 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: * The age of diagnosis is less than 1 year old * The disgnosisi of ALL or ALAL(lymphoid predominant) * Informed consent of the parents(guardians) before participation in this study Exclusion Criteria: * Burkitt leukemia/lymphoma or mature B-cell leukemia * Down syndrome, Bloom syndrome, ataxia-telangiectasia, Fanconi anemia, Kostmann syndrome, Shwachman syndrome or other bone marrow failure syndrome, hematopoietic stem cell transplantation * Relapsed infant leukemia * Participants with contraindication to medication * Administered systemic steroid therapy within 4 weeks prior to this study (However, steroid administration is allowable in oncologic emergencies only after the subject's disease diagnosis and risk group classification are completed.) * Participants in other interventional studies other than this protocol

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Conditions

The condition(s) this trial relates to.

acute leukemia of ambiguous lineage acute lymphoblastic leukemia lymphoid leukemia

As listed by the trial registrant

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

Leukemia, lymphoid

How to take part

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

  1. The places running it

    10 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

  • Asan Medical Center

    RECRUITING

    Seoul, South Korea

  • Chonnam National University Hwasun Hospital

    RECRUITING

    Hwasun, South Korea

  • Chungnam National University Hospital

    NOT_YET_RECRUITING

    Daejeon, South Korea

  • Jeju National University Hospital

    RECRUITING

    Jeju City, South Korea

  • Kyungpook National University Chilgok-Hospital

    NOT_YET_RECRUITING

    Daegu, South Korea

  • Pusan National University Yangsan Hospital

    RECRUITING

    Pusan, South Korea

  • Samsung Medical Cente

    RECRUITING

    Seoul, South Korea

  • Seoul National University Hospital

    RECRUITING

    Seoul, South Korea

  • Seoul saint Mary's Hospital

    RECRUITING

    Seoul, South Korea

  • Severance Hospital

    RECRUITING

    Seoul, South Korea

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