Study summary

The purpose of this study is to compare relapse-free survival (RFS) between subjects with FMS-like tyrosine kinase 3 (FLT3) / internal tandem duplication (ITD) acute myeloid leukemia (AML) in first complete remission (CR1) and who are randomized to receive gilteritinib or placebo beginning after completion of induction/consolidation chemotherapy for a two-year period.

Additional Study Details

Phase
Phase 2
Product
ASP2215
Product
gilteritinib
Placebo
Type
Interventional
Masking
Double (Participant, Investigator)
Enrollment number
98
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), Administered as Maintenance Therapy Following Induction/Consolidation Therapy for Subjects with FMS-like tyrosine kinase 3 (FLT3/ITD) Acute Myeloid Leukemia (AML) in First Complete Remission? Contact us by filling out your information to the right and we’ll respond to you.

  • A caregiver
  • A healthcare provider
  • A parent
  • A patient
  • 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 JP81011
    Tachikawa, Tokyo, Japan
    Withdrawn
    Site KR82001
    Ulsan, Republic of Korea, 44033
    Withdrawn
    Site ES34003
    Girona, Girona, Spain, 17007
    Completed
    Site KR82006
    Busan, Republic of Korea, 49241
    Completed
    Site JP81025
    Matsuyama, Ehime, Japan
    Completed
    Site IT39010
    Reggio Emilia, Italy, 42100
    Withdrawn
    Site PT35103
    Lisboa, Portugal, 1169-050
    Withdrawn
    Site DK45003
    Odense, Region Syddanmark, Denmark, 5000
    Withdrawn
    Site BR55003
    Campinas, Brazil
    Withdrawn
    Site RO40008
    Cluj-Napoca, Romania
    Withdrawn
    Site JP81013
    Kurashiki, Okayama, Japan
    Withdrawn
    Site DE49009
    Rostock, Mecklenburg-Vorpommern, Germany, 18057
    Active, not recruiting
    Site HU36003
    Nyiregyhaza, Szabolcs-Szatmar-Bereg, Hungary, H-4400
    Withdrawn
    Site DK45001
    Copenhagen, Denmark, 2100
    Withdrawn
    Site US10031
    Seattle, WA, United States, 98104
    Active, not recruiting
    Site BR55002
    Goiania, Goias, Brazil, 74605-020
    Withdrawn
    Site FR33006
    MEAUX, Seine-et-Marne, France, 77100
    Completed
    Site US10029
    Greenville, SC, United States, 26615
    Withdrawn
    Site ES34001
    L'Hospitalet de Llobregat, Barcelona, Spain, 08907
    Withdrawn
    Site ES34004
    La Laguna-Sta.Cruz de Tenerife, Spain, 38320
    Withdrawn
    Site TW88606
    Taichung, Taichung, Taiwan, Province of China, 40705
    Withdrawn
    Site IT39009
    Catania, Italy, 95124
    Withdrawn
    Site RO40004
    Bucuresti, Bucuresti, Romania, 050098
    Active, not recruiting
    Site JP81009
    Yokohama, Kanagawa, Japan
    Completed
    Site ES34009
    Vitoria, Alava, Spain, 01009
    Completed
    Site PL48002
    Bydgoszcz, Poland, 85-168
    Withdrawn
    Site JP81005
    Narita, Chiba, Japan
    Withdrawn
    Site IT39006
    Torino, Italy
    Completed
    Site KR82012
    Seoul, Seoul Teugbyeolsi, Republic of Korea, 06351
    Completed
    Site KR82013
    Goyang, Gyeonggido, Republic of Korea, 10408
    Withdrawn
    Site GB44003
    Middlesex, Harrow, United Kingdom, HA1 3UJ
    Withdrawn
    Site FR33016
    Aix-en-Provence cedex, Bouches-du-Rhone, France, 13616
    Withdrawn
    Site GR30005
    Athens, Attiki, Greece, 10676
    Withdrawn
    Site SE46001
    Linkoeping, Ostergotlands lan, Sweden, 581 85
    Withdrawn
    Site US10028
    New York, NY, United States, 10021
    Active, not recruiting
    Site GB44002
    Birmingham, United Kingdom, B95SS
    Withdrawn
    Site IT39007
    Mirano, Venezia, Italy, 30035
    Withdrawn
    Site BR55005
    Sao Paulo, Brazil
    Withdrawn
    Site AR54003
    Buenos Aires, Argentina
    Active, not recruiting
    Site US10007
    Portland, OR, United States, 97239
    Withdrawn
    Site GB44008
    Manchester, United Kingdom, M20 4BX
    Withdrawn
    Site TR90002
    Istanbul, Turkey, 34093
    Completed
    Site GR30007
    Larissa, Greece
    Withdrawn
    Site JP81006
    Nagoya, Aichi, Japan
    Withdrawn
    Site US10013
    Los Angeles, CA, United States, 90003
    Active, not recruiting
    Site GR30004
    Thessaloniki, Kentriki Makedonia, Greece, 57010
    Completed
    Site IT39011
    Milano, Lombardia, Italy, 20141
    Active, not recruiting
    Site GR30009
    Athens, Greece
    Completed
    Site FR33002
    Tours cedex 01, Indre-et-Loire, France, 37044
    Withdrawn
    Site US10002
    Durham, NC, United States, 27705
    Completed
    Site TW88605
    Kaohsiung, Taiwan, Province of China, 112
    Withdrawn
    Site CA15005
    Montreal, Quebec, Canada, H4A 3J1
    Withdrawn
    Site US10022
    Canton, OH, United States, 44718
    Active, not recruiting
    Site GB44019
    Plymouth, Devon, United Kingdom, PL6 8DH
    Withdrawn
    Site ES34006
    Valladolid, Spain, 47005
    Withdrawn
    Site GB44017
    West Midlands, Coventry, United Kingdom, CV2 2DX
    Active, not recruiting
    Site DK45002
    Arhus, Region Midtjylland, Denmark, DK 8000
    Withdrawn
    Site ES34008
    Madrid, Madrid, Spain, 28040
    Completed
    Site FR33014
    Vandoeuvre les Nancy, Meurthe-et-Moselle, France, 54511
    Withdrawn
    Site TR90003
    Izmir, Turkey, 35340
    Withdrawn
    Site HR38501
    Zagreb, Grad Zagreb, Croatia
    Withdrawn
    Site US10018
    New York, NY, United States, 10016
    Active, not recruiting
    Site JP81017
    Okayama, Okayama, Japan
    Completed
    Site KR82009
    Seoul, Republic of Korea, 120-752
    Withdrawn
    Site RO40007
    Tirgu-Mures, Romania
    Completed
    Site GB44018
    London, London, City of, United Kingdom, WC1E 6BT
    Withdrawn
    Site IT39001
    Milano, Italy
    Active, not recruiting
    Site GB44007
    Exeter, Devon, United Kingdom, EX2 5DW
    Withdrawn
    Site TW88602
    Taipei, Taipei, Taiwan, Province of China, 10449
    Withdrawn
    Site FR33013
    Strasbourg, France, 67000
    Completed
    Site US10017
    Gainesville, FL, United States, 32610-0278
    Withdrawn
    Site US10026
    Boston, MA, United States, 02111
    Withdrawn
    Site CA15004
    Regina, Saskatchewan, Canada, S4T 7T1
    Withdrawn
    Site PL48003
    Warszawa, Mazowieckie, Poland, 02-106
    Active, not recruiting
    Site JP81023
    Shimotsuke, Tochigi, Japan
    Withdrawn
    Site TR90011
    Aydin, Aydın, Turkey, 09100
    Active, not recruiting
    Site FR33008
    Nice Cedex 2, France, 06189
    Withdrawn
    Site HU36004
    Debrecen, Hungary, H-4032
    Withdrawn
    Site TR90007
    Samsun, Samsun, Turkey, 55139
    Withdrawn
    Site JP81020
    Fukuoka, Fukuoka, Japan
    Completed
    Site JP81012
    Kobe, Hyogo, Japan
    Withdrawn
    Site HU36001
    Budapest, Hungary, H 1083
    Withdrawn
    Site KR82007
    Seoul, Seoul Teugbyeolsi, Republic of Korea, 110-744
    Completed
    Site GB44015
    Cardiff, United Kingdom, CF4 4XN
    Withdrawn
    Site JP81001
    Nagano, Nagano, Japan
    Active, not recruiting
    Site JP81018
    Nagoya, Aichi, Japan
    Withdrawn
    Site ES34010
    Pamplona, Navarra, Spain, 31008
    Withdrawn
    Site DE49005
    Greifswald, Germany, 17475
    Withdrawn
    Site US10023
    Whittier, CA, United States, 90603
    Withdrawn
    Site JP81022
    Sapporo, Hokkaido, Japan
    Active, not recruiting
    Site PL48001
    Olsztyn, Warmińsko-mazurskie, Poland, 10-228
    Withdrawn
    Site HU36006
    Szeged, Csongrad, Hungary, H-6725
    Active, not recruiting
    Site DE49008
    Stuttgart, Germany, 70376
    Withdrawn
    Site TR90006
    Ankara, Ankara, Turkey, 06500
    Withdrawn
    Site BR55004
    Barretos, Sao Paulo, Brazil, 14784-400
    Active, not recruiting
    Site CA15001
    Halifax, Nova Scotia, Canada, B3H2Y9
    Active, not recruiting
    Site CA15003
    Toronto, ON, Canada, M5G 2M9
    Completed
    Site IL97205
    Jerusalem, Yerushalayim, Israel, 91031
    Withdrawn
    Site JP81007
    Maebashi, Gunma, Japan
    Withdrawn
    Site AR54002
    Ciudad Autonoma de Buenos Aires, Argentina
    Withdrawn
    Site RS38101
    Belgrade, Serbia, 11000
    Withdrawn
    Site TR90008
    Ankara, Ankara, Turkey, 06500
    Withdrawn
    Site RO40001
    Iasi, Romania, 10171
    Withdrawn
    Site US10001
    Winston-Salem, NC, United States, 27157
    Completed
    Site KR82005
    Suwon-si, Gyeonggi-do, Republic of Korea, 16499
    Withdrawn
    Site US10009
    Fairfax, VA, United States, 22031
    Completed
    Site RS38102
    Belgrade, Serbia, 11000
    Withdrawn
    Site GR30011
    Athens, Greece
    Active, not recruiting
    Site SE46003
    Stockholm, Stockholms lan, Sweden, 171 76
    Completed
    Site KR82003
    Hwasungun, Jeonranamdo, Republic of Korea, 58128
    Withdrawn
    Site CL56002
    Temuco, Araucania, Chile, 4810469
    Withdrawn
    Site US10004
    Detroit, MI, United States, 48202
    Completed
    Site US10012
    Chicago, IL, United States, 60612
    Active, not recruiting
    Site GB44006
    Cottingham, East Riding of Yorkshire, United Kingdom, HU165JQ
    Withdrawn
    Site GB44012
    Leicester, ENGLAND, United Kingdom, LE1 5WW
    Withdrawn
    Site IT39003
    Parma, Italy
    Withdrawn
    Site FR33018
    Argenteuil, Val-d'Oise, France, 95107
    Completed
    Site FR33007
    Pierre-Benite, Rhone, France, 69310
    Withdrawn
    Site FR33012
    Valenciennes, France, 59300
    Active, not recruiting
    Site KR82014
    Bucheon-Si, Gyeonggido, Republic of Korea, 14584
    Withdrawn
    Site GB44011
    Manchester, United Kingdom, M13 9WL
    Withdrawn
    Site AU61006
    Liverpool, New South Wales, Australia, 2170
    Active, not recruiting
    Site FR33001
    Bayonne, France, 64100
    Withdrawn
    Site JP81016
    Nagasaki, Nagasaki, Japan
    Active, not recruiting
    Site GB44020
    Leeds, Leeds, United Kingdom, LS9 7TF
    Completed
    Site US10025
    Syracuse, NY, United States, 13210
    Withdrawn
    Site JP81019
    Suita, Osaka, Japan
    Withdrawn
    Site US10020
    Charleston, SC, United States, 29425
    Active, not recruiting
    Site PL48007
    Poznan, Poland
    Withdrawn
    Site JP81021
    Akita, Akita, Japan
    Completed
    Site TW88604
    Kaohsiung, Taiwan, Province of China, 83301
    Withdrawn
    Site JP81015
    Kyoto, Kyoto, Japan
    Completed
    Site PT35106
    Coimbra, Portugal, 3000
    Completed
    Site IT39002
    Roma, Roma, Italy, 161
    Withdrawn
    Site GR30003
    Athens, Attiki, Greece
    Active, not recruiting
    Site JP81004
    Kanazawa, Ishikawa, Japan
    Withdrawn
    Site JP81008
    Shinagawa-ku, Tokyo, Japan
    Completed
    Site TW88603
    Taipei, Taiwan, Province of China, 114
    Withdrawn
    Site TW88601
    Kweishan Hsiang, Taoyuan, Taiwan, Province of China, 33305
    Withdrawn
    Site ES34002
    Madrid, Madrid, Spain, 28050
    Withdrawn
    Site HR38502
    Zagreb, Grad Zagreb, Croatia, 10000
    Completed
    Site KR82008
    Namdong, Incheon Gwang'yeogsiv, Republic of Korea, 405 760
    Withdrawn
    Site TR90009
    Adana, Adana, Turkey, 01250
    Withdrawn
    Site IT39012
    Verona, Verona, Italy, 37134
    Completed
    Site CZ42001
    Ostrava-Poruba, Czech Republic, 70852
    Withdrawn
    Site US10024
    Hawthorne, NY, United States, 10532
    Active, not recruiting
    Site JP81002
    Yoshida-gun, Fukui, Japan
    Active, not recruiting
    Site JP81010
    Aomori, Aomori, Japan
    Active, not recruiting
    Site US10030
    Jacksonville, FL, United States, 32204
    Completed
    Site IT39005
    Parma, Italy
    Active, not recruiting
    Site DE49001
    Duisburg, Nordrhein-Westfalen, Germany, 47166
    Completed
    Site JP81014
    Sendai, Miyagi, Japan
    Withdrawn
    Site GR30002
    Alexandroupolis, Evros, Greece, 68100
    Withdrawn
    Site FR33011
    Paris, Ile-de-France, France, 75010
    Completed
    Site IT39004
    Castelfranco Veneto (TV), Treviso, Italy, 31033
    Withdrawn
    Site AR54001
    Cordoba, Argentina, X5000JHQ
    Withdrawn
    Site GB44014
    Cambridge, United Kingdom
    Withdrawn
    Site IL97201
    Rehovot, HaMerkaz, Israel, 7610001
    Active, not recruiting
    Site JP81024
    Sapporo, Hokkaido, Japan
    Active, not recruiting
    Site FR33009
    Mulhouse, France, 68070
    Withdrawn
    Site US10015
    Louisville, KY, United States, 40207
    Active, not recruiting
    Site GR30010
    Athens, Attiki, Greece, 10676
    Withdrawn
    Site GB44005
    Bristol, United Kingdom, BS2 8ED
    Withdrawn
    Site TR90001
    Kayseri, Turkey, 38039
    Withdrawn
    Site US10019
    Augusta, GA, United States, 30912
    Withdrawn
    Site GR30008
    Larissa, Greece, 41110
    Withdrawn
    Site GR30001
    Rio Patras, Achaia, Greece, 26504
    Withdrawn
    Site BR55007
    Porto Alegre, Brazil
    Withdrawn
    Site TR90012
    Izmir, Turkey
    Withdrawn
    Site JP81003
    Isehara, Kanagawa, Japan
    Withdrawn
    Site KR82002
    Seoul, Republic of Korea, 06591
    Active, not recruiting
    Site FR33004
    Brest, Finistere, France, 29609
    Withdrawn
    Site AU61005
    Geelong, Victoria, Australia, 3220
    Withdrawn
    Site PL48005
    Warszawa, Poland, 02-776
    Withdrawn
    Site IL97202
    Jerusalem, HaMerkaz, Israel, 91120
    Completed
    Site RO40005
    București, Romania
    Withdrawn
    Site FR33017
    Avignon, Provence-Alpes-Cote-d'Azur, France, 84902
    Withdrawn
    Site FR33010
    Perpignan, Languedoc-Roussillon, France, 66046
    Withdrawn
    Site TR90010
    Gaziantep, Turkey
    Withdrawn
    Site AU61002
    Southport, Queensland, Australia, 4215
    Withdrawn
    Site ES34012
    Sevilla, Sevilla, Spain, 41014
    Completed
    Site SE46002
    Lund, Sweden, 221 85
    Withdrawn
    Site FR33003
    Toulouse Cedex 9, Haute-Garonne, France, 31059
    Active, not recruiting
    Site IT39008
    Bergamo, Italy, 24127
    Withdrawn
    Site TR90005
    Denizli, Denizli, Turkey, 20070
    Withdrawn
    Site KR82004
    Seoul, Republic of Korea, 05505
    Active, not recruiting
    Site PT35101
    Porto, Porto, Portugal, 4200-072
    Withdrawn
    Site RO40002
    Targu Mures, Mures, Romania, 540136
    Withdrawn
    Site HU36007
    Pecs, Hungary, H-7624
    Active, not recruiting
    Site GB44004
    Nottingham, United Kingdom, NG5 1PB
    Withdrawn
    Site US10035
    Indianapolis, IN, United States, 46237
    Withdrawn
    Site RO40003
    Bucuresti, Bucureşti, Romania, 022328
    Withdrawn
    Site RO40006
    Craiova, Romania

    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?