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New combo therapy shows promise for aggressive blood cancer

NCT ID NCT02310321

Completed Disease control Sponsor: Astellas Pharma Inc Source: ClinicalTrials.gov ↗

First seen Jun 26, 2026 · Last updated Jun 26, 2026

Summary

This study tested a drug called gilteritinib (Xospata) alongside standard chemotherapy in 97 people newly diagnosed with acute myeloid leukemia (AML), especially those with a FLT3 gene mutation. The first part aimed to find the safest dose, and the second part measured how many patients achieved complete remission. Results helped determine the recommended dose for further studies.

What this could mean

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

Active substance
Gilteritinib (Xospata) combined with chemotherapy drugs idarubicin and cytarabine
What this could lead to
If successful, this combination could improve remission rates for people with a specific genetic type of AML, offering a more effective first treatment.
What could go wrong
This is an early-phase trial with only 97 participants, so results may not apply to all patients. The drug combination also carries risks of serious side effects like infections and bleeding.

This is an AI summary of the original study and may miss details. Read our disclaimer.

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Conditions

The condition(s) this trial relates to.

acute myeloid leukemia acute myeloid leukemia, FLT3 internal tandem duplication

As listed by the trial registrant

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

ACUTE MYELOID LEUKEMIA FLT3-MUTATED ACUTE MYELOID LEUKEMIA

Contacts and locations

Locations

  • SIte JP81011

    Ōmura, Nagasaki, Japan

  • Site JP00001

    Fukuoka, Japan

  • Site JP00002

    Maebashi, Gunma, Japan

  • Site JP00003

    Nagoya, Aichi-ken, Japan

  • Site JP00005

    Shinagawa-ku, Tokyo, Japan

  • Site JP00006

    Yokohama, Kanagawa, Japan

  • Site JP00007

    Kobe, Hyōgo, Japan

  • Site JP81001

    Maebashi, Gunma, Japan

  • Site JP81003

    Nagoya, Aichi-ken, Japan

  • Site JP81004

    Fukuoka, Japan

  • Site JP81005

    Yokohama, Kanagawa, Japan

  • Site JP81006

    Kobe, Hyōgo, Japan

  • Site JP81007

    Yoshida-gun, Fukui, Japan

  • Site JP81008

    Chiba, Japan

  • Site JP81009

    Okayama, Japan

  • Site JP81010

    Narita, Chiba, Japan

  • Site JP81012

    Nagasaki, Japan

  • Site JP81013

    Isehara, Kanagawa, Japan

  • Site JP81014

    Sapporo, Hokkaido, Japan

  • Site JP81015

    Sapporo, Hokkaido, Japan

  • Site JP81016

    Kyoto, Japan

  • Site JP81018

    Ōtake, Hiroshima, Japan

  • Site JP81019

    Osaka, Japan

  • Site JP81020

    Kanazawa, Ishikawa-ken, Japan

  • Site JP81021

    Osaka, Japan

  • Site JP81022

    Shimono, Tochigi, Japan

  • Site JP81023

    Tsukuba, Ibaraki, Japan

  • Site JP81024

    Yokohama, Kanagawa, Japan

  • Site JP81025

    Fukuoka, Japan

  • Site JP81026

    Fukuyama, Hiroshima, Japan

  • Site JP81027

    Nagoya, Aichi-ken, Japan

  • Site JP81028

    Kumamoto, Japan

  • Site JP81029

    Akita, Japan

  • Site JP81030

    Gifu, Japan

  • Site JP81031

    Fukushima, Japan

  • Site JP81032

    Shinagawa-ku, Tokyo, Japan

  • Site JP81033

    Kochi, Japan

  • Site JP81035

    Sendai, Miyagi, Japan

  • Site JP81036

    Mito, Ibaraki, Japan

  • Site JP81037

    Anjo, Aichi-ken, Japan

  • Site JP81038

    Toyohashi, Aichi-ken, Japan

  • Site JP81039

    Matsuyama, Ehime, Japan

  • Site JP81040

    Bunkyo-ku, Tokyo, Japan

  • Site JP81041

    Tenri, Nara, Japan

  • Site JP81043

    Himeji, Hyōgo, Japan

  • Site KR82001

    Seoul, South Korea

  • Site KR82002

    Incheon, South Korea

  • Site KR82003

    Seoul, South Korea

  • Site KR82004

    Seoul, South Korea

  • Site KR82005

    Busan, South Korea

  • Site KR82006

    Seoul, South Korea

  • Site TW88601

    Tainan, Taiwan

  • Site TW88602

    Taichung, Taiwan

  • Site TW88603

    Taoyuan, Taiwan

  • Site TW88604

    Kaohsiung City, Taiwan

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