Study summary

This was a clinical study for adult participants who were recently diagnosed with acute myeloid leukemia or AML. AML is a type of cancer. It is when bone marrow makes white blood cells that are not normal. These are called leukemia cells. Some participants with AML have a mutation, or change, in the FLT3 gene. This gene helps leukemia cells make a protein called FLT3. This protein causes the leukemia cells to grow faster.

For participants with AML who could not receive standard chemotherapy, azacitidine (also known as Vidaza®) was a current standard of care treatment option in the United States. This clinical study tested an experimental medicine called ASP2215, also known as gilteritinib. Gilteritinib worked by stopping the leukemia cells from making the FLT3 protein. This helped stop the leukemia cells from growing faster.

This study compared two different treatments. Participants were assigned to one of these two groups by chance: a medicine called azacitidine, also known as Vidaza®, or an experimental medicine gilteritinib in combination with azacitidine. There was a twice as much chance to receive both medicines combined than azacitidine alone. The clinical study may help show which treatment helps patients live longer.

Additional Study Details

Phase
Phase 3
Product
gilteritinib
Product
gilteritinib
azacitidine
Type
Interventional
Masking
None (Open Label)
Enrollment number
183
Show Additional Study Details

Get more information

Would you like more information about clinical trial sites that are recruiting participants for A study of ASP2215 (gilteritinib) by itself, ASP2215 combined with azacitidine or azacitidine by itself to treat adult patients who have recently been diagnosed with acute myeloid leukemia with a FLT3 gene mutation and who cannot receive standard chemotherapy? Contact us by filling out your information to the right and we’ll respond to you.

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  • Algeria
  • Argentina
  • Armenia
  • Australia
  • Austria
  • Belarus
  • Belgium
  • Bosnia And Herzegovina
  • Brazil
  • Bulgaria
  • Canada
  • Chile
  • China
  • Colombia
  • Croatia
  • Czech Republic
  • Denmark
  • Dominican Republic
  • Egypt
  • Estonia
  • Finland
  • Former Serbia and Montenegro
  • France
  • Georgia
  • Germany
  • Greece
  • Guatemala
  • Hong Kong
  • Hungary
  • Iceland
  • India
  • Indonesia
  • Ireland
  • Israel
  • Italy
  • Japan
  • Jordan
  • Kazakhstan
  • Latvia
  • Lebanon
  • Lithuania
  • Macedonia
  • Malaysia
  • Mexico
  • Montenegro
  • Morocco
  • Netherlands
  • New Zealand
  • Norway
  • Panama
  • Peru
  • Philippines
  • Poland
  • Portugal
  • Puerto Rico
  • Republic of Korea
  • Republic of Moldova
  • Romania
  • Russian Federation
  • Saudi Arabia
  • Serbia
  • Singapore
  • Slovakia
  • Slovenia
  • South Africa
  • Spain
  • Sweden
  • Switzerland
  • Taiwan, Province of China
  • Thailand
  • Turkey
  • Ukraine
  • United Kingdom
  • United States
  • Vietnam

By clicking ["Continue/Submit"], you agree that Astellas may contact you by email with information to help you connect with clinical trial sites. While we can connect you to clinical trial sites, we cannot answer questions about any investigational therapy through email. Your consent to receiving emails is not a requirement to participate in a clinical trial or study. For more information, including how to unsubscribe at any time, see our Privacy Notice & Cookies Policy.

    Locations

    Contact Us
    Contact Us
    Completed
    Site TW88601
    Taipei, Taiwan, Province of China, 10002
    Completed
    Site ES34013
    Madrid, Spain
    Completed
    Site JP81021
    Fukuyama, Hiroshima, Japan
    Completed
    UCLA David Geffen School of Medicine
    Los Angeles, CA, United States, 90095
    Withdrawn
    Site JP81006
    Sapporo, Hokkaido, Japan
    Completed
    Site FR33019
    Montpellier Cedex 5, Herault, France, 34295
    Completed
    Site TW88605
    Kwei Shan Hsiang, Taiwan, Province of China
    Withdrawn
    Site FR33022
    Paris Cedex 10, Paris, France, 75475
    Withdrawn
    Site JP81003
    Yokohama, Kanagawa, Japan
    Completed
    Site KR82003
    Namdong, Incheon Gwang'yeogsiv, Republic of Korea, 405 760
    Completed
    Site DE49009
    Halle (Saale), Sachsen-Anhalt, Germany, 06120
    Completed
    Site JP81017
    Nagasaki, Nagasaki, Japan
    Completed
    Site JP81032
    Yokohama, Kanagawa, Japan
    Withdrawn
    University of Florida
    Gainesville, FL, United States, 32610-0278
    Completed
    Site JP81011
    Kurashiki, Okayama, Japan
    Completed
    Site JP81030
    Osaka, Osaka, Japan
    Completed
    Site AU61008
    Adelaide, SA, Australia, SA 5000
    Completed
    Hematology-Oncology Associates of Northern NJ
    Morristown, NJ, United States, 07962
    Withdrawn
    Indiana Blood Marrow Transplantation
    Indianapolis, IN, United States, 46237
    Completed
    Site KR82006
    Seoul, Seoul Teugbyeolsi, Republic of Korea, 110-744
    Completed
    Site BE32007
    Brussel, Bruxelles, Belgium, 1090
    Completed
    Site DE49012
    Braunschweig, Niedersachsen, Germany, 38118
    Completed
    Site PL48001
    Olsztyn, Warmińsko-mazurskie, Poland, 10-228
    Withdrawn
    Baylor Research Institute
    Dallas, TX, United States, 75246
    Completed
    Site ES34005
    Valencia, Valencia, Spain, 46026
    Withdrawn
    Site FR33005
    Amiens, Somme, France, 80054
    Withdrawn
    Mount Sinai Downtown Union Square
    New York, NY, United States, 10003
    Completed
    Site IT39012
    Firenze, Italy
    Completed
    Site KR82015
    Seongnam-si, Republic of Korea
    Withdrawn
    SUNY Upstate Medical University
    Syracuse, NY, United States, 13210
    Withdrawn
    Manhattan Hematology Oncology Associates, P.C.
    New York, NY, United States, 10016
    Withdrawn
    Site FR33007
    Le Chesnay Cedex, France, 78157
    Completed
    Site IT39005
    Pavia, Italy
    Completed
    GHS Cancer Institute
    Greenville, SC, United States, 26615
    Completed
    Site ES34002
    CACERES, Caceres, Spain, 10003
    Completed
    Site CA15002
    Toronto, ON, Canada, M5G 2M9
    Completed
    Site KR82013
    Seoul, Seoul Teugbyeolsi, Republic of Korea, 05505
    Completed
    Site DE49007
    Munchen, Bayern, Germany, 81737
    Completed
    Site JP81016
    Kyoto, Kyoto, Japan
    Completed
    Site IT39011
    San Giovanni Rotondo, Italy, 71013
    Completed
    Site DE49005
    Frankfurt, Hessen, Germany, 60590
    Completed
    Site FR33003
    Nimes Cedex 09, Gard, France, 30029
    Completed
    Site PL48003
    Lublin, Lubelskie, Poland, 20-081
    Withdrawn
    Site ES34012
    Valladolid, Spain
    Completed
    Robert H. Lurie Comprehensive Cancer Center
    Chicago, IL, United States, 60611-5975
    Withdrawn
    Augusta University - Georgia Cancer Center
    Augusta, GA, United States, 30912
    Completed
    Site TW88610
    Taipei, Taiwan, Province of China, 11217
    Completed
    Site FR33013
    Pierre-Benite, Rhone, France, 69310
    Withdrawn
    Site BE32008
    Montigny-le-Tilleul, Hainaut, Belgium, 6110
    Withdrawn
    Site AU61012
    Camperdown, NSW, Australia, 2050
    Completed
    Site ES34003
    Oviedo, Asturias, Spain, 33011
    Completed
    Site IT39004
    Milano, Milano, Italy, 20162
    Completed
    Site TW88604
    Kaohsiung, Taiwan, Province of China, 83301
    Completed
    Site PL48002
    Opole, Opolskie, Poland, 45-061
    Completed
    Memorial Sloan-Kettering Cancer Center
    New York, NY, United States, 10021
    Completed
    Site JP81012
    Sendai, Miyagi, Japan
    Completed
    Site IT39009
    Ancona, Italy, 60126
    Completed
    Site JP81029
    Shibuya-ku, Tokyo, Japan
    Completed
    Site IT39007
    Monza, Italy
    Withdrawn
    University of Chicago
    Chicago, IL, United States, 60637
    Completed
    Site FR33006
    Lille, France, 59037
    Completed
    Site ES34010
    Barcelona, Spain, 08036
    Withdrawn
    Site CA15004
    Halifax, NS, Canada, B3H 2Y9
    Completed
    Site TW88608
    Taipei, Taipei, Taiwan, Province of China, 10449
    Completed
    Site JP81023
    Kanazawa, Ishikawa, Japan
    Completed
    Site FR33015
    Rouen, Haute-Normandie, France, 76038
    Completed
    Site BE32003
    Bruxelles, Bruxelles-Capitale, Region de, Belgium, 1200
    Completed
    Site JP81014
    Shinagawa-ku, Tokyo, Japan
    Completed
    Site DE49002
    Tuebingen, Baden-Wurttemberg, Germany, 72076
    Withdrawn
    University of Southern California
    Los Angeles, CA, United States, 90033
    Completed
    Site JP81007
    Nagoya, Aichi, Japan
    Withdrawn
    Site JP81010
    Maebashi, Gunma, Japan
    Completed
    Site GB44007
    Sheffield, United Kingdom, S10 2JF
    Completed
    Site ES34004
    Barcelona, Barcelona, Spain, 08035
    Completed
    Site FR33002
    Pessac, Gironde, France, 33604
    Completed
    Site PL48004
    Warszawa, Mazowieckie, Poland, 02-776
    Completed
    Site JP81018
    Anjo, Aichi, Japan
    Withdrawn
    Yale-New Haven Hospital (YNHH) - Smilow Cancer Hospital
    New Haven, CT, United States, 06510-3220
    Completed
    LDS Hospital
    Salt Lake City, UT, United States, 84143
    Completed
    Site DE49015
    Rostock, Mecklenburg-Vorpommern, Germany, 18057
    Completed
    Roswell Park Cancer Institute
    Buffalo, NY, United States, 14263
    Completed
    Site JP81026
    Tokushima, Tokushima, Japan
    Completed
    Site IT39014
    Novara, Italy
    Completed
    Site KR82001
    Ulsan, Ulsan Gwang'yeogsi, Republic of Korea, 682-714
    Completed
    Hackensack University Medical Center - John Theurer Cancer Center
    Hackensack, NJ, United States, 07601
    Withdrawn
    Swedish Cancer Institute / Swedish Health Services
    Seattle, WA, United States, 98104
    Withdrawn
    Norton Cancer Institute
    Louisville, KY, United States, 40207
    Completed
    Site CA15006
    Montreal, QC, Canada, H4A 3J1
    Completed
    Site IT39006
    Palermo, Italy, 90146
    Withdrawn
    Medical City Dallas Hospital
    Dallas, TX, United States, 75230
    Completed
    Site KR82010
    Hwasun-gun, Republic of Korea
    Completed
    Site JP81036
    Osaka, Osaka, Japan
    Withdrawn
    Loyola University Medical Center
    Maywood, IL, United States, 60153
    Completed
    Site KR82002
    Seoul, Seoul Teugbyeolsi, Republic of Korea, 137-701
    Completed
    Site KR82012
    Seoul, Republic of Korea, 156-707
    Completed
    University of California, Irvine Medical Center
    Orange, CA, United States, 92868
    Withdrawn
    Tulane University Health Sciences Center
    New Orleans, LA, United States, 70112
    Completed
    Site FR33018
    Rennes, Ille-et-Vilaine, France, 35033
    Completed
    Site FR33023
    Valenciennes, Nord, France, 59322
    Completed
    Site FR33004
    Lille cedex, France, 59020
    Withdrawn
    Site ES34011
    Coruna, A Coruna, Spain, 15006
    Withdrawn
    Site DE49008
    Bonn, Nordrhein-Westfalen, Germany, 53105
    Withdrawn
    Penn State Hershey Cancer Institute
    Hershey, PA, United States, 17033-0850
    Completed
    Site JP81033
    Sapporo, Hokkaido, Japan
    Completed
    Site AU61007
    Geelong, Victoria, Australia, 3220
    Completed
    Site JP81008
    Fukuoka, Fukuoka, Japan
    Completed
    Site KR82014
    Busan, Republic of Korea, 49241
    Completed
    Site IT39001
    Napoli, Italy, 80131
    Completed
    Site JP81035
    Chiba, Chiba, Japan
    Completed
    Site JP81024
    Gifu, Gifu, Japan
    Completed
    Site JP81004
    Nagasaki, Nagasaki, Japan
    Withdrawn
    Site JP81037
    Kyoto, Kyoto, Japan
    Withdrawn
    Site IT39002
    Varese, Italy
    Withdrawn
    Site IT39003
    Milano, Italy
    Completed
    Site CA15011
    Toronto, Ontario, Canada, M4N 3M5
    Withdrawn
    University of Oklahoma Health Sciences Center
    Oklahoma City, OK, United States, 73104
    Completed
    Site JP81001
    Isehara, Kanagawa, Japan
    Completed
    Site JP81034
    Hitachi, Ibaraki, Japan
    Withdrawn
    Site FR33014
    Vandoeuvre les Nancy, Meurthe-et-Moselle, France, 54500
    Withdrawn
    Site JP81022
    Tachikawa, Tokyo, Japan
    Completed
    Site FR33020
    Bayonne, France
    Completed
    Site IT39015
    Bologna, Italy, 40138
    Completed
    Site DE49003
    Berlin, Germany, 13353
    Completed
    Site ES34008
    Barcelona, Barcelona, Spain, 08003
    Completed
    Site FR33012
    Poitiers, Vienne, France, 86000
    Completed
    Site ES34007
    Palma de Mallorca, Baleares, Spain, 07010
    Completed
    Site ES34009
    Barcelona, Barcelona, Spain, 8041
    Withdrawn
    Site TW88607
    Taichung, Taichung, Taiwan, Province of China, 40705
    Completed
    Site AU61004
    Liverpool, New South Wales, Australia, 2170
    Completed
    Site BE32006
    Gent, Belgium, 9000
    Completed
    Site CA15009
    Edmonton, AB, Canada, T6G 2B7
    Completed
    Site FR33001
    Nantes cedex 01, Loire-Atlantique, France, 44093
    Completed
    Site FR33017
    Le Mans, Sarthe, France, 72037
    Completed
    Site FR33009
    Angers, France, 49033
    Withdrawn
    Site FR33016
    Limoges, Haute-Vienne, France, 87042
    Completed
    Site DE49004
    Hannover, Niedersachsen, Germany, 30625
    Withdrawn
    Site DE49013
    Heilbronn, Germany, 74078
    Completed
    Site DE49011
    Stuttgart, Germany, 70376
    Completed
    Site JP81005
    Kumamoto, Kumamoto, Japan
    Completed
    Site JP81015
    Kobe, Hyogo, Japan
    Completed
    Site JP81027
    Matsuyama, Ehime, Japan
    Completed
    Site JP81031
    Sapporo, Hokkaido, Japan
    Completed
    Site JP81019
    Toyama, Toyama, Japan
    Withdrawn
    Site KR82008
    Seoul, Seoul Teugbyeolsi, Republic of Korea, 06351
    Withdrawn
    Site PL48005
    Krakow, Małopolskie, Poland, 31-501
    Completed
    Site TW88609
    Tainan, Tainan, Taiwan, Province of China, 736
    Completed
    Site TW88602
    Tainan, Taiwan, Province of China, 704
    Withdrawn
    Site GB44004
    London, London, City of, United Kingdom, EC1A 7BE
    Withdrawn
    Eastern Maine Medical Center - CancerCare of Maine
    Brewer, ME, United States, 04412
    Completed
    Weill Cornell Medical College-New York Presbyterian Hospital
    New York, NY, United States, 10021
    Completed
    Rush University Medical Center
    Chicago, IL, United States, 60612
    Completed
    St. Louis University Cancer Center - Hematology/Oncology
    St. Louis, Missouri, United States, 63110
    Withdrawn
    The University of Texas MD Anderson Cancer Center
    Houston, TX, United States, 77030
    Withdrawn
    Orlando Health Inc - Clinic
    Orlando, FL, United States, 32806

    Frequently Asked Questions

    Are clinical trials only for people with advanced cancer?

    While some clinical trials may focus on more advanced cancers, many trials are open to patients at various stages of their cancer. Each study has rules about who can take part. For example, only patients in a certain age group or those who have a certain type of tumor may be able to join.

    Will I have to stop my current treatment to participate in a clinical trial?

    Sometimes researchers want participants to keep taking their current treatments during a clinical trial. Other times, you may need to stop your current treatments for a while. If the investigational treatment doesn't work, you can usually go back to your original treatment plan.

    Should I be worried about getting a placebo?

    In cancer clinical trials, a placebo is only used if there is no other treatment for that type of cancer. This helps compare an investigational treatment to the placebo. Placebos are rarely used in cancer trials because the best available treatment, called the “standard of care”, is usually given instead.

    Do I need a referral from my doctor to take part in a study?

    Your doctor may not know about all the opportunities for clinical trials that are available to you. Talk to your doctor or other medical provider about clinical trial information that you find. They can help you decide if a clinical trial is right for you. If you do not find any options on this website, we recommend you visit an online public registry website like clinicaltrials.gov to see a wide variety of available clinical trials.

    Explore More

    1

    What are clinical trials?

    2

    Why are Clinical Trials Important?

    3

    Why Participate in a Clinical Trial?