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Can a targeted drug combo beat the toughest childhood leukemia?

NCT ID NCT06257394

Cure Sponsor: Hyoung Jin Kang 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 Results may not be published yet.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This status has not been confirmed recently, so it may be out of date.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 adding dasatinib and blinatumomab to standard chemotherapy can improve outcomes for children aged 1 to 19 with very high-risk acute lymphoblastic leukemia. The study focuses on patients with specific genetic markers or who did not respond to initial treatment. The goal is to see if this approach can prevent relapse and improve survival.

What this could mean

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

Active substance
dasatinib (Sprycel) and blinatumomab
What this could lead to
If successful, this approach could improve survival and reduce relapse in children with the most aggressive forms of leukemia.
What could go wrong
This is an early-phase trial with a small number of participants, so results may not apply broadly. The treatments carry risks like infection 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 74 people

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

Started

Oct 2024

Expected to finish

Dec 2034

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: * Pediatric patients diagnosed with ALL between the ages of 1 and 19 years at the time of diagnosis who meet one or more of the following conditions: * Philadelphia chromosome-positive t(9;22)(q34;q11) or * Patients with failed remission who had blast \> 5% on bone marrow test after initial remission induction therapy or * Hypodiploidy (Number of chromosomes \< 44 (less than 44)) or * E2A-HLF(Hepatic Leukemia Factor) translocation-positive or * When the prognosis is judged to be poor according to NGS-MRD results among high-risk ALL patients (i) In B-ALL, the NGS-MRD(Next Generation Sequencing-Minimal Residual Disease) after consolidation therapy is 0.01% or more, and the NGS-MRD followed during interim maintenance treatment is also 0.01% or more, (ii) In T-ALL, NGS-MRD(Next Generation Sequencing-Minimal Residual Disease) is more than 0.01% after consolidation therapy Exclusion Criteria: * Participants with contraindications to medications * When the study participant or their legal representative withdraws consent * Pregnant or lactating women (patients of child-bearing potential require adequate contraception during the study period) * Participants who are medically unsuitable to participate in this study at the discretion of the investigator Participants participating in other interventional studies other than this protocol

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Conditions

The condition(s) this trial relates to.

acute lymphoblastic leukemia childhood acute lymphoblastic leukemia Precursor Cell Lymphoblastic Leukemia-Lymphoma

As listed by the trial registrant

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

Acute lymphoblastic leukemia, pediatric

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, 05505, South Korea

  • Chonnam National University Hwasun Hospital

    RECRUITING

    Hwasun, 58128, South Korea

  • Chungnam National University Hospital

    RECRUITING

    Daejeon, 35015, South Korea

  • Jeju National University Hospital

    RECRUITING

    Jeju City, 63241, South Korea

  • Kyungpook National University Chilgok-Hospital

    RECRUITING

    Daegu, 41404, South Korea

  • Pusan National University Yangsan Hospital

    RECRUITING

    Yangsan, 50612, South Korea

  • Samsung Medical Center

    RECRUITING

    Seoul, 06351, 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

More trials for these conditions

Other studies related to the condition(s) this trial covers.