Study summary

The purpose of this study is to determine the clinical benefit of ASP2215 therapy in participants with FMS-like tyrosine kinase (FLT3) mutated acute myeloid leukemia (AML) who are refractory to or have relapsed after first-line AML therapy as shown with overall survival (OS) compared to salvage chemotherapy, and to determine the efficacy of ASP2215 therapy as assessed by the rate of complete remission and complete remission with partial hematological recovery (CR/CRh) in these participants.

This study will also determine the overall efficacy in event-free survival (EFS) and complete remission (CR) rate of ASP2215 compared to salvage chemotherapy.

Additional Study Details

Phase
Phase 3
Product
  • gilteritinib
  • LoDAC (Low Dose Cytarabine)
  • Azacitidine
  • MEC (Mitoxantrone, Etoposide, Cytarabine)
  • FLAG-IDA (Granulocyte-Colony Stimulating Factor (G-CSF), Fludarabine, Cytarabine, Idarubicin)
  • Type
    Interventional
    Masking
    None (Open Label)
    Enrollment number
    371
    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 versus Salvage Chemotherapy in Patients with Relapsed or Refractory Acute Myeloid Leukemia (AML) with FMS-like tyrosine kinase (FLT3) Mutation? Contact us by filling out your information to the right and we’ll respond to you.

    • A patient
    • A caregiver
    • A parent
    • 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

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      Locations

      Contact Us
      Contact Us
      Withdrawn
      Site US10083
      Evanston, IL, United States, 60201
      Completed
      Site US10058
      Oklahoma City, OK, United States, 73104
      Completed
      Site JP81024
      Okayama, Okayama, Japan
      Completed
      Site FR33002
      Le Chesnay Cedex, France, 78157
      Completed
      Site PL48004
      Wroclaw, Poland, 50-367
      Completed
      Site US10001
      Buffalo, NY, United States, 14263
      Completed
      Site US10006
      Chicago, IL, United States, 60637
      Completed
      Site CA15004
      Edmonton, AB, Canada, T6G 2G3
      Completed
      Site US10087
      Detroit, MI, United States, 48201
      Completed
      Site TW88602
      Taipei, Taiwan, Province of China, 114
      Completed
      Site US10085
      Boston, MA, United States, 02215
      Completed
      Site IL97209
      Haifa, Israel, 31096
      Completed
      Site ES34014
      Salamanca, Spain, 37007
      Withdrawn
      Site TR90008
      Izmir, Turkey, 35340
      Completed
      Site JP81026
      Yoshida-gun, Fukui, Japan
      Completed
      Site ES34009
      Badalona, Spain, 08025
      Completed
      Site KR82004
      Seoul, Republic of Korea, 120-752
      Completed
      Site GB44015
      Plymouth, United Kingdom, PL6 8DH
      Completed
      Site FR33013
      Brest, France, 29609
      Withdrawn
      Site US10007
      Houston, TX, United States, 77030
      Completed
      Site US10046
      Syracuse, NY, United States, 13210
      Completed
      Site US10010
      Philadelphia, PA, United States, 19104
      Completed
      Site JP81004
      Shinagawa-ku, Tokyo, Japan
      Completed
      Site US10041
      Hershey, PA, United States, 17033
      Completed
      Site CA15001
      Hamilton, ON, Canada, L8V 1C3
      Completed
      Site GB44003
      Manchester, United Kingdom, M13 9WL
      Completed
      Site GB44013
      Harrow, United Kingdom, HA1 3UJ
      Completed
      Site FR33009
      Pessac, France, 33604
      Completed
      Site US10057
      Minneapolis, MN, United States, 55455
      Completed
      Site IL97203
      Jerusalem, Israel, 91031
      Completed
      Site TW88601
      Tainan, Taiwan, Province of China, 704
      Withdrawn
      Site DE49004
      Wurzburg, Germany, 97070
      Completed
      Site US10037
      New York, NY, United States, 10029
      Completed
      Site IT39011
      Pavia, Italy, 27100
      Completed
      Site TW88611
      Taipei, Taiwan, Province of China, 112
      Withdrawn
      Site PL48003
      Slupsk, Poland, 76-200
      Completed
      Site TW88609
      Taichung City, Taiwan, Province of China, 40705
      Completed
      Site US10076
      Orange, CA, United States, 92868
      Completed
      Site DE49003
      Marburg, Germany, 35043
      Completed
      Site JP81022
      Shinjuku-ku, Tokyo, Japan
      Completed
      Site US10024
      Durham, NC, United States, 27710
      Completed
      Site US10044
      Cleveland, OH, United States, 44106
      Withdrawn
      Site BE32008
      Bruxelles, Bruxelles-Capitale, Region de, Belgium, 1000
      Completed
      Site US10084
      Columbus, OH, United States, 43210
      Completed
      Site US10080
      Philadelphia, PA, United States, 19107
      Completed
      Site ES34011
      Barcelona, Spain, 08035
      Withdrawn
      Site US10079
      Stony Brook, NY, United States, 11794
      Completed
      Site TR90004
      Ankara, Turkey, 06500
      Completed
      Site JP81007
      Kurashiki, Okayama, Japan
      Withdrawn
      Site US10086
      Chicago, IL, United States, 60637
      Completed
      Site US10063
      Nashville, TN, United States, 37232-0656
      Completed
      Site IT39007
      Roma, Italy, 00189
      Completed
      Site DE49002
      Munchen, Germany, 81737
      Completed
      Site ES34005
      L'Hospitalet de Llobregat, Spain, 08907
      Completed
      Site US10078
      Winston-Salem, NC, United States, 27157
      Completed
      Site JP81002
      Nagoya, Aichi, Japan
      Completed
      Site US10023
      Lebanon, NH, United States, 03756-1000
      Completed
      Site JP81012
      Sendai, Miyagi, Japan
      Completed
      Site JP81006
      Yokohama, Kanagawa, Japan
      Completed
      Site JP81016
      Sapporo, Hokkaido, Japan
      Completed
      Site US10011
      Birmingham, AL, United States, 35294-0006
      Completed
      Site US10081
      Atlanta, GA, United States, 30342
      Completed
      Site KR82011
      Seoul, Republic of Korea, 156-707
      Completed
      Site JP81025
      Kyoto, Kyoto, Japan
      Withdrawn
      Site ES34015
      Madrid, Spain, 28006
      Completed
      Site US10077
      New Brunswick, NJ, United States, 08903
      Completed
      Site US10073
      San Francisco, CA, United States, 94143
      Completed
      Site JP81023
      Akita, Akita, Japan
      Completed
      Site IL97201
      Ashkelon, Israel, 78278
      Completed
      Site US10034
      Boston, MA, United States, 02114
      Completed
      Site ES34012
      Barcelona, Spain, 08036
      Completed
      Site IL97210
      Jerusalem, Israel, 91120
      Withdrawn
      Site BE32001
      Brugge, Belgium, 8000
      Completed
      Site JP81011
      Osaka, Osaka, Japan
      Completed
      Site BE32002
      Yvoir, Belgium, 5530
      Completed
      Site IT39004
      Palermo, Italy, 90146
      Completed
      Site TW88604
      Kaohsiung, Taiwan, Province of China, 83301
      Completed
      Site DE49010
      Tubingen, Germany, 72076
      Completed
      Site IT39002
      Varese, Italy, 21100
      Withdrawn
      Site JP81001
      Fukuoka, Fukuoka, Japan
      Completed
      Site KR82008
      Seoul, Republic of Korea, 138-736
      Completed
      Site KR82003
      Jeollanam-do, Republic of Korea, 519-809
      Completed
      Site CA15015
      Toronto, ON, Canada, M5G 2M9
      Completed
      Site JP81027
      Shimotsuke, Tochigi, Japan
      Completed
      Site DE49011
      Leipzig, Germany, 04103
      Withdrawn
      Site FR33011
      Angers, France, 49000
      Completed
      Site IT39001
      Milan, Italy, 20132
      Withdrawn
      Site BE32010
      Antwerp, Belgium, 2060
      Withdrawn
      Site IE35304
      Dublin, Ireland, 9
      Completed
      Site KR82010
      Busan, Republic of Korea, 602739
      Completed
      Site US10072
      New York, NY, United States, 10065
      Completed
      Site KR82009
      Goyang, Republic of Korea, 602-715
      Completed
      Site TW88603
      Taipei, Taiwan, Province of China, 10002
      Completed
      Site KR82005
      Suwon-si, Gyeonggi-do, Republic of Korea, 443380
      Completed
      Site US10022
      Boston, MA, United States, 02215
      Completed
      Site US10027
      Hackensack, NJ, United States, 07601
      Withdrawn
      Site CA15016
      Montreal, QC, Canada, H3H 2R9
      Completed
      Site US10005
      Baltimore, MD, United States, 21201
      Completed
      Site IL97208
      Rehovot, Israel, 76100
      Completed
      Site KR82002
      Seoul, Republic of Korea, 137701
      Completed
      Site CA15003
      Montreal, QC, Canada, H1T 2M4
      Completed
      Site US10045
      Gainesville, FL, United States, 32610
      Completed
      Site JP81005
      Chuo-ku, Tokyo, Japan
      Withdrawn
      Site JP81003
      Maebashi, Gunma, Japan
      Completed
      Site IT39010
      Brescia, Italy, 25126
      Completed
      Site US10012
      Los Angeles, CA, United States, 90095-1752
      Withdrawn
      Site US10033
      Maywood, IL, United States, 60153
      Completed
      Site JP81021
      Aomori, Aomori, Japan
      Completed
      Site TR90001
      Ankara, Turkey, 06100
      Completed
      Site JP81014
      Osakasayama, Osaka, Japan
      Completed
      Site KR82001
      Seoul, Republic of Korea, 135710
      Completed
      Site JP81008
      Nagasaki, Nagasaki, Japan
      Completed
      Site FR33010
      Lille, France, 59037
      Completed
      Site PL48002
      Gdansk, Poland, 80-952
      Completed
      Site JP81009
      Isehara, Kanagawa, Japan
      Completed
      Site US10013
      New York, NY, United States, 10065
      Completed
      Site FR33008
      Toulouse, France, 31059
      Completed
      Site ES34017
      Valencia, Spain, 46026
      Completed
      Site US10067
      New Haven, CT, United States, 06504
      Completed
      Site PL48005
      Opole, Poland, 45-372
      Completed
      Site ES34010
      Barcelona, Spain, 08916
      Completed
      Site US10075
      Westwood, KS, United States, 66205
      Completed
      Site KR82007
      Seoul, Republic of Korea, 110-744
      Completed
      Site TW88610
      Taipei, Taiwan, Province of China, 10449
      Completed
      Site TW88606
      Kaohsiung, Taiwan, Province of China, 112
      Completed
      Site GB44014
      Bournemouth, United Kingdom, BH7 7DW
      Completed
      Site DE49009
      Dresden, Germany, 01307
      Completed
      Site JP81018
      Kobe, Hyogo, Japan
      Completed
      Site ES34016
      Girona, Spain, 17007
      Completed
      Site US10008
      New York, NY, United States, 10032
      Completed
      Site US10048
      New Orleans, LA, United States, 70112
      Completed
      Site JP81010
      Narita, Chiba, Japan
      Completed
      Site US10014
      Charleston, SC, United States, 29425
      Completed
      Site JP81017
      Tsukuba, Ibaraki, Japan
      Completed
      Site US10074
      Louisville, KY, United States, 40202
      Completed
      Site IT39005
      Bologna, Italy, 40138
      Completed
      Site JP81013
      Kumamoto, Kumamoto, Japan
      Completed
      Site FR33014
      Rennes, France, 35033
      Completed
      Site US10035
      Milwaukee, WI, United States, 53226
      Completed
      Site TW88608
      Taichung, Taiwan, Province of China, 404
      Completed
      Site TW88605
      Taoyuan, Taiwan, Province of China, 33305
      Completed
      Site IL97206
      Petah Tikva, Israel, 49100
      Completed
      Site JP81020
      Kawagoe, Saitama, Japan
      Withdrawn
      Site US10054
      Worcester, MA, United States, 01655

      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.

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