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New hope for kids with relapsed AML: targeted drug combo trial opens

NCT ID NCT03793478

Disease control Sponsor: Daiichi Sankyo Source: ClinicalTrials.gov ↗

What the study statuses mean

This study's is highlighted.

Recruitment status, easiest to join first

Recruiting now
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 This study
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 Results may not be published yet.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This status has not been confirmed recently, so it may be out of date.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 Jun 27, 2026

Summary

This study tests an experimental drug called quizartinib, given with chemotherapy, for children and young adults (ages 1 month to 21 years) whose acute myeloid leukemia (AML) has returned or not responded to treatment. The goal is to see if the combination is safe and can help control the cancer. Participants must have a specific genetic change (FLT3-ITD) in their leukemia cells.

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 1/2

Runs two stages together: safety and dose first, then whether the treatment works.

Participants

About 65 people

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

Started

Aug 2018

Expected to finish

May 2027

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 month to 21 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: Participants must meet all of the following criteria to be eligible for enrollment into the study: * Has diagnosis of AML according to the World Health Organization (WHO) 2008 classification with ≥5% blasts in bone marrow, with or without extramedullary disease * In first relapse or refractory to first-line high-dose chemotherapy with no more than 1 attempt (1 to 2 cycles of induction chemotherapy) at remission induction - prior HSCT is permitted * Has presence of the FLT3-ITD activating mutation in bone marrow or peripheral blood as defined in the protocol * Is between 1 month and 21 years of age at the time the Informed Consent/Assent form is signed * Has protocol-defined adequate performance status score * Has fully recovered from the acute clinically significant toxicity effects of all prior chemotherapy, immunotherapy, or radiotherapy, per protocol guidelines * Has protocol-defined adequate renal, hepatic and cardiac functions * If of reproductive potential, is permanently sterile or agrees to use highly effective birth control upon enrollment, during the period of therapy, and for 6 months following the last dose of quizartinib, etoposide, fludarabine, methotrexate, or cytarabine, whichever is later * If female of child-bearing potential, tests negative for pregnancy and agrees not to breast feed * Male participants must be surgically sterile or willing to use highly effective birth control during the treatment period, and for 6 months following the last dose of quizartinib, etoposide, fludarabine, methotrexate, or cytarabine, whichever is later. * Participant/legal representative is capable of understanding the investigational nature of the study, potential risks, and benefits, and the patient (and/or legal representative) signs a written assent/informed consent Exclusion Criteria: Participants who meet any of the following criteria will be disqualified from entering the study: * Has been diagnosed with isolated central nervous system relapse, acute promyelocytic leukemia (APL), juvenile myelomonocytic leukemia, French-American-British classification M3 or WHO classification of APL with translocation, or with myeloid proliferations related to Down syndrome * Has uncontrolled or pre-defined significant cardiovascular disease as detailed in the protocol * Has systemic fungal, bacterial, viral or other infection that is exhibiting ongoing signs/symptoms related to the infection without improvement despite appropriate antibiotics or other treatment. The patient must be off vasopressors and have negative blood cultures for at least 48 hours prior to the start of systematic protocol therapy. * Has known active clinically relevant liver disease (e.g., active hepatitis B or active hepatitis C) * Has known history of human immunodeficiency virus (HIV) * Has history of hypersensitivity to any of the study medications or their excipients * Is receiving or is anticipated to receive concomitant chemotherapy, radiation, or immunotherapy other than as specified in the protocol * Has any significant concurrent disease, illness, psychiatric disorder or social issue that would compromise subject safety or compliance, interfere with consent/assent, study participation, follow up, or interpretation of study results * Is currently participating in another investigative interventional procedure (observational or long-term interventional follow-up is allowed) * Is otherwise considered inappropriate for the study by the Investigator

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Conditions

The condition(s) this trial relates to.

acute myeloid leukemia acute myeloid leukemia, FLT3 internal tandem duplication Recurrence

As listed by the trial registrant

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

Acute myeloid leukemia

Contacts and locations

Locations

  • A.I. duPont Hospital for Children

    Wilmington, Delaware, 19803, United States

  • British Columbia Children's Hospital

    Vancouver, V6H 3V4, Canada

  • Centre Léon Bérard

    Lyon, 69008, France

  • Children's Healthcare of Atlanta

    Atlanta, Georgia, 30322, United States

  • Children's Hospital Colorado

    Aurora, Colorado, 80045, United States

  • Children's National Medical Center

    Washington D.C., District of Columbia, 20010, United States

  • Cincinnati Children's Hospital Medical Center

    Cincinnati, Ohio, 45229, United States

  • Fondazione IRCCS San Gerardo dei Tintori

    Monza, 20900, Italy

  • Hospital Infantil Universitario Nino Jesus

    Madrid, 28009, Spain

  • Hospital Universitario La Paz

    Madrid, 28046, Spain

  • Hôpital Armand-Trousseau

    Paris, 75012, France

  • Hôpital des Enfants

    Toulouse, 31300, France

  • IRCCS Ospedale Pediatrico Bambino Gesù

    Rome, 00165, Italy

  • Loma Linda University Cancer Center

    Loma Linda, California, 92354, United States

  • Ospedale Infantile Regina Margherita

    Torino, 10126, Italy

  • Prinses Maxima Centrum voor Kinderoncologie

    Utrecht, 3584 EA, Netherlands

  • Rambam Medical Center

    Haifa, 31096, Israel

  • Rigshospitalet

    Copenhagen, 2100, Denmark

  • Sahlgrenska Universitetssjukhuset - Drottning Silvias Barn- och Ungdomssjukhus

    Gothenburg, 41685, Sweden

  • Seattle Children's Hospital

    Seattle, Washington, 98105, United States

  • Tel Aviv Sourasky Medical Center

    Tel Aviv, 64239, Israel

  • The Hospital for Sick Children

    Toronto, Ontario, M5G1X8, Canada

  • The University of Texas Southwestern Medical Center Children's Health

    Dallas, Texas, 75390, United States

  • UPMC Children's Hospital of Pittsburgh

    Pittsburgh, Pennsylvania, 15224, United States

  • Universitair Ziekenhuis Gent

    Ghent, Belgium

  • University of California, San Francisco

    San Francisco, California, 94158, United States

  • University of Minnesota/Masonic Cancer Center

    Minneapolis, Minnesota, 55455, United States

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