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.

Disclaimer Read more

This is a summary of the original study . Summaries may miss details or leave out important information. Before applying or accepting participation, make sure you have read and understood the full study. Curemydisease.com takes no responsibility whatsoever for anything missed, misunderstood, or acted upon as a result of our summary — we know it does not capture everything.

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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

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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