Study summary

This is a clinical study for adult patients who have recently been 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 patients 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 patients with AML who cannot receive standard chemotherapy, azacitidine (also known as Vidaza®) is a current standard of care treatment option in the United States. This clinical study is testing an experimental medicine called ASP2215, also known as gilteritinib. Gilteritinib works by stopping the leukemia cells from making the FLT3 protein. This can help stop the leukemia cells from growing faster.

This study will compare two different treatments. Patients are 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 is 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
  • 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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    • A healthcare provider
    • A patient advocate
    • 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?

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      Why are Clinical Trials Important?

      3

      Why Participate in a Clinical Trial?