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 fumarate
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

Study documents

Protocol
Available Language(s): English
Statistical Analysis Plan (SAP)
Available Language(s): English

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.

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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
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  • India
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  • United States
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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
    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
    Active, not recruiting
    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
    Active, not recruiting
    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
    Active, not recruiting
    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
    Active, not recruiting
    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
    Active, not recruiting
    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
    Active, not recruiting
    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
    Active, not recruiting
    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
    Active, not recruiting
    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
    Active, not recruiting
    Site US10072
    New York, NY, United States, 10065
    Completed
    Site KR82009
    Goyang, Republic of Korea, 602-715
    Active, not recruiting
    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
    Active, not recruiting
    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
    Active, not recruiting
    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
    Active, not recruiting
    Site FR33008
    Toulouse, France, 31059
    Active, not recruiting
    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
    Active, not recruiting
    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
    Active, not recruiting
    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
    Active, not recruiting
    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?

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    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.

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