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New hope for kids with leukemia: drug trial targets cancer control

NCT ID NCT07354074

Disease control Sponsor: Novartis Pharmaceuticals 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 Results may not be published yet.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This status has not been confirmed recently, so it may be out of date.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 Jun 27, 2026 · Last updated Sep 03, 2026 · Updated 7 times

Summary

This study tests a drug called asciminib in children aged 1 to 18 with a specific leukemia (Ph+ CML-CP). The goal is to see if the drug can control the cancer by reducing the number of cancer cells. About 50 children will take the drug, and researchers will check how well it works and if it is safe. This is not a cure, as children will need to keep taking the drug to manage their disease.

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 50 people

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

Started

Apr 2026

Expected to finish

Feb 2033

An estimate. End dates often move.

Lead sponsor

A company

The lead sponsor is a pharmaceutical, biotech, or medical-device company.

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 18 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.

Key Inclusion Criteria: Participants eligible for inclusion in this study must meet all of the following criteria: 1. Signed informed consent must be obtained prior to participation in the study. 2. Male or female participants 1 and \< 18 years of age at study enrollment 3. Diagnosis of CML-CP (Apperley et al 2025) with cytogenetic confirmation of Philadelphia positive (Ph+) chromosome 4. For participants with CML-CP newly diagnosed within 3 months of screening OR 5 For participants with CML - CP with high risk of developing resistance or intolerance to previous TKI: 1. Unfavourable response to TKI is defined following the Apperley et al 2025 guidelines as: * At three months after the initiation of therapy: BCR::ABL1 ratio \> 10% IS (if confirmed within 1-3 months) * At six months after the initiation of therapy: BCR::ABL1 ratio \> 10% IS * At twelve months after initiation of therapy: BCR::ABL1 ratio \> 1% IS * At any time loss of previous response * At any time emergent resistant BCR::ABL1 mutations or high-risk ACA from prior TKI treatment as per local test results 2. Intolerance to TKI is defined as: * Non-hematologic intolerance: participants with grade 3 or 4 toxicity while on therapy (in which case the patient is eligible whether or not there was a dose reduction); or with persistent grade 2 toxicity unresponsive to optimal management including dose adjustments (unless dose reduction is not considered in the best interest of the patient if response is already suboptimal) * Hematologic intolerance: participants with grade 3 or 4 toxicity (absolute neutrophil count \[ANC\] or platelets) while on therapy that is recurrent after dose reduction to the lowest doses of the TKI 6\. Evidence of typical BCR::ABL1 transcript \[e14a2 and/or e13a2\] at the time of screening which are amenable to standardized RQ-PCR quantification. 7\. Performance status: Karnofsky ≥ 50% for participants ≥ 16 years of age, and Lansky ≥ 50 for participants \< 16 years of age at the time of screening. Key Exclusion Criteria: 1. Known second chronic phase (CP) of CML after previous progression to Accelerated Phase (AP)/Blast Phase (BP). 2. Previous treatment with a hematopoietic stem-cell transplantation. 3. Patient planned to undergo allogeneic hematopoietic stem cell transplantation 4. Known presence of a BCR::ABL1 mutation with known resistance to study treatment in accordance with the most recent public version of international CML clinical guidelines (e.g. NCCN CML treatment guidelines v 1.2026 and Apperley et al 2025) any time prior to study entry Other inclusion/exclusion criteria may apply.

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Conditions

The condition(s) this trial relates to.

Bronchiolitis Obliterans Syndrome chronic myelogenous leukemia, BCR-ABL1 positive leukemia Leukemia, Myelogenous, Chronic, BCR-ABL Positive

As listed by the trial registrant

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

Chronic myelogenous leukemia Leukemia, myelogenous, chronic, philadelphia chromosome positive

How to take part

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

  1. The places running it

    30 sites in 13 countries. 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

  • Cinn Children Hosp Medical Center

    RECRUITING

    Cincinnati, Ohio, 45229-3039, United States

  • Columbia University Medical Center New York Presbyterian

    RECRUITING

    New York, New York, 10032, United States

  • Novartis Investigative Site

    RECRUITING

    Brisbane, Queensland, 4101, Australia

  • Novartis Investigative Site

    RECRUITING

    North Adelaide, South Australia, 5066, Australia

  • Novartis Investigative Site

    RECRUITING

    Rio de Janeiro, Rio de Janeiro, 20211-030, Brazil

  • Novartis Investigative Site

    RECRUITING

    Barretos, São Paulo, 14784-400, Brazil

  • Novartis Investigative Site

    RECRUITING

    São Paulo, São Paulo, 04829-310, Brazil

  • Novartis Investigative Site

    RECRUITING

    Edmonton, Alberta, T6G 1C9, Canada

  • Novartis Investigative Site

    RECRUITING

    Montreal, Quebec, H3T 1C5, Canada

  • Novartis Investigative Site

    RECRUITING

    Zhengzhou, Henan, 450003, China

  • Novartis Investigative Site

    RECRUITING

    Tianjin, 300020, China

  • Novartis Investigative Site

    RECRUITING

    Marseille, 13885, France

  • Novartis Investigative Site

    RECRUITING

    Paris, 75019, France

  • Novartis Investigative Site

    RECRUITING

    Poitiers, 86021, France

  • Novartis Investigative Site

    RECRUITING

    Strasbourg, 67000, France

  • Novartis Investigative Site

    RECRUITING

    Frankfurt am Main, Hesse, 60590, Germany

  • Novartis Investigative Site

    RECRUITING

    Erlangen, 91054, Germany

  • Novartis Investigative Site

    RECRUITING

    Roma, RM, 00165, Italy

  • Novartis Investigative Site

    RECRUITING

    Yokohama, Kanagawa, 2328555, Japan

  • Novartis Investigative Site

    RECRUITING

    Fukuoka, 8128582, Japan

  • Novartis Investigative Site

    RECRUITING

    Saitama, 3308777, Japan

  • Novartis Investigative Site

    RECRUITING

    Utrecht, 3584 CS, Netherlands

  • Novartis Investigative Site

    RECRUITING

    Gdansk, 80-214, Poland

  • Novartis Investigative Site

    RECRUITING

    Wroclaw, 50-556, Poland

  • Novartis Investigative Site

    RECRUITING

    Seoul, 03080, South Korea

  • Novartis Investigative Site

    RECRUITING

    Seoul, 06591, South Korea

  • Novartis Investigative Site

    RECRUITING

    Barcelona, 08035, Spain

  • Novartis Investigative Site

    RECRUITING

    Madrid, 28009, Spain

  • Rutgers Cancer Institute of New Jersey

    RECRUITING

    New Brunswick, New Jersey, 08901, United States

  • Seattle Childrens Hospital

    RECRUITING

    Seattle, Washington, 98105, United States

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