Study Details
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
Clinicaltrials.gov ID
Astellas Study ID
2215-CL-0302
EudraCT ID
2016-001643-39
Condition
Leukemia - AML
Phase
Phase 2
Age
18 Years - N/A
Sex
Female & Male
Product
gilteritinib
Type
Interventional
Trial Dates
Jan 2017 - Feb 2024
Masking
Double (Participant, Investigator)
Enrollment number
98
A Phase 2 Multicenter, Randomized, Double-Blind, Placebo-Controlled Trial of the FLT3 Inhibitor Gilteritinib (ASP2215) Administered as Maintenance Therapy Following Induction/Consolidation Therapy for Subjects with FLT3/ITD AML in First Complete Remission
Study summary
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Locations
Site JP81011
Tachikawa, Japan
Site KR82001
Ulsan, Republic of Korea, 44033
Site ES34003
Girona, Spain, 17007
Site KR82006
Busan, Republic of Korea, 49241
Site JP81025
Matsuyama, Japan
Site IT39010
Reggio Emilia, Italy, 42100
Site PT35103
Lisboa, Portugal, 1169-050
Site DK45003
Odense, Denmark, 5000
Site BR55003
Campinas, Brazil
Site RO40008
Cluj-Napoca, Romania
Site JP81013
Kurashiki, Japan
Site DE49009
Rostock, Germany, 18057
Site HU36003
Nyiregyhaza, Hungary, H-4400
Site DK45001
Copenhagen, Denmark, 2100
Site US10031
Seattle, United States, 98104
Site BR55002
Goiania, Brazil, 74605-020
Site FR33006
MEAUX, France, 77100
Site US10029
Greenville, United States, 26615
Site ES34001
L'Hospitalet de Llobregat, Spain, 08907
Site ES34004
La Laguna-Sta.Cruz de Tenerife, Spain, 38320
Site TW88606
Taichung, Taiwan, Province of China, 40705
Site IT39009
Catania, Italy, 95124
Site RO40004
Bucuresti, Romania, 050098
Site JP81009
Yokohama, Japan
Site ES34009
Vitoria, Spain, 01009
Site PL48002
Bydgoszcz, Poland, 85-168
Site JP81005
Narita, Japan
Site IT39006
Torino, Italy
Site KR82012
Seoul, Republic of Korea, 06351
Site KR82013
Goyang, Republic of Korea, 10408
Site GB44003
Middlesex, United Kingdom, HA1 3UJ
Site FR33016
Aix-en-Provence cedex, France, 13616
Site GR30005
Athens, Greece, 10676
Site SE46001
Linkoeping, Sweden, 581 85
Site US10028
New York, United States, 10021
Site GB44002
Birmingham, United Kingdom, B95SS
Site IT39007
Mirano, Italy, 30035
Site BR55005
Sao Paulo, Brazil
Site AR54003
Buenos Aires, Argentina
Site US10007
Portland, United States, 97239
Site GB44008
Manchester, United Kingdom, M20 4BX
Site TR90002
Istanbul, Turkey, 34093
Site GR30007
Larissa, Greece
Site JP81006
Nagoya, Japan
Site US10013
Los Angeles, United States, 90003
Site GR30004
Thessaloniki, Greece, 57010
Site IT39011
Milano, Italy, 20141
Site GR30009
Athens, Greece
Site FR33002
Tours cedex 01, France, 37044
Site US10002
Durham, United States, 27705
Site TW88605
Kaohsiung, Taiwan, Province of China, 112
Site CA15005
Montreal, Canada, H4A 3J1
Site US10022
Canton, United States, 44718
Site GB44019
Plymouth, United Kingdom, PL6 8DH
Site ES34006
Valladolid, Spain, 47005
Site GB44017
West Midlands, United Kingdom, CV2 2DX
Site DK45002
Arhus, Denmark, DK 8000
Site ES34008
Madrid, Spain, 28040
Site FR33014
Vandoeuvre les Nancy, France, 54511
Site TR90003
Izmir, Turkey, 35340
Site HR38501
Zagreb, Croatia
Site US10018
New York, United States, 10016
Site JP81017
Okayama, Japan
Site KR82009
Seoul, Republic of Korea, 120-752
Site RO40007
Tirgu-Mures, Romania
Site GB44018
London, United Kingdom, WC1E 6BT
Site IT39001
Milano, Italy
Site GB44007
Exeter, United Kingdom, EX2 5DW
Site TW88602
Taipei, Taiwan, Province of China, 10449
Site FR33013
Strasbourg, France, 67000
Site US10017
Gainesville, United States, 32610-0278
Site US10026
Boston, United States, 02111
Site CA15004
Regina, Canada, S4T 7T1
Site PL48003
Warszawa, Poland, 02-106
Site JP81023
Shimotsuke, Japan
Site TR90011
Aydin, Turkey, 09100
Site FR33008
Nice Cedex 2, France, 06189
Site HU36004
Debrecen, Hungary, H-4032
Site TR90007
Samsun, Turkey, 55139
Site JP81020
Fukuoka, Japan
Site JP81012
Kobe, Japan
Site HU36001
Budapest, Hungary, H 1083
Site KR82007
Seoul, Republic of Korea, 110-744
Site GB44015
Cardiff, United Kingdom, CF4 4XN
Site JP81001
Nagano, Japan
Site JP81018
Nagoya, Japan
Site ES34010
Pamplona, Spain, 31008
Site DE49005
Greifswald, Germany, 17475
Site US10023
Whittier, United States, 90603
Site JP81022
Sapporo, Japan
Site PL48001
Olsztyn, Poland, 10-228
Site HU36006
Szeged, Hungary, H-6725
Site DE49008
Stuttgart, Germany, 70376
Site TR90006
Ankara, Turkey, 06500
Site BR55004
Barretos, Brazil, 14784-400
Site CA15001
Halifax, Canada, B3H2Y9
Site CA15003
Toronto, Canada, M5G 2M9
Site IL97205
Jerusalem, Israel, 91031
Site JP81007
Maebashi, Japan
Site AR54002
Ciudad Autonoma de Buenos Aires, Argentina
Site RS38101
Belgrade, Serbia, 11000
Site TR90008
Ankara, Turkey, 06500
Site RO40001
Iasi, Romania, 10171
Site US10001
Winston-Salem, United States, 27157
Site KR82005
Suwon-si, Republic of Korea, 16499
Site US10009
Fairfax, United States, 22031
Site RS38102
Belgrade, Serbia, 11000
Site GR30011
Athens, Greece
Site SE46003
Stockholm, Sweden, 171 76
Site KR82003
Hwasungun, Republic of Korea, 58128
Site CL56002
Temuco, Chile, 4810469
Site US10004
Detroit, United States, 48202
Site US10012
Chicago, United States, 60612
Site GB44006
Cottingham, United Kingdom, HU165JQ
Site GB44012
Leicester, United Kingdom, LE1 5WW
Site IT39003
Parma, Italy
Site FR33018
Argenteuil, France, 95107
Site FR33007
Pierre-Benite, France, 69310
Site FR33012
Valenciennes, France, 59300
Site KR82014
Bucheon-Si, Republic of Korea, 14584
Site GB44011
Manchester, United Kingdom, M13 9WL
Site AU61006
Liverpool, Australia, 2170
Site FR33001
Bayonne, France, 64100
Site JP81016
Nagasaki, Japan
Site GB44020
Leeds, United Kingdom, LS9 7TF
Site US10025
Syracuse, United States, 13210
Site JP81019
Suita, Japan
Site US10020
Charleston, United States, 29425
Site PL48007
Poznan, Poland
Site JP81021
Akita, Japan
Site TW88604
Kaohsiung, Taiwan, Province of China, 83301
Site JP81015
Kyoto, Japan
Site PT35106
Coimbra, Portugal, 3000
Site IT39002
Roma, Italy, 161
Site GR30003
Athens, Greece
Site JP81004
Kanazawa, Japan
Site JP81008
Shinagawa-ku, Japan
Site TW88603
Taipei, Taiwan, Province of China, 114
Site TW88601
Kweishan Hsiang, Taiwan, Province of China, 33305
Site ES34002
Madrid, Spain, 28050
Site HR38502
Zagreb, Croatia, 10000
Site KR82008
Namdong, Republic of Korea, 405 760
Site TR90009
Adana, Turkey, 01250
Site IT39012
Verona, Italy, 37134
Site CZ42001
Ostrava-Poruba, Czech Republic, 70852
Site US10024
Hawthorne, United States, 10532
Site JP81002
Yoshida-gun, Japan
Site JP81010
Aomori, Japan
Site US10030
Jacksonville, United States, 32204
Site IT39005
Parma, Italy
Site DE49001
Duisburg, Germany, 47166
Site JP81014
Sendai, Japan
Site GR30002
Alexandroupolis, Greece, 68100
Site FR33011
Paris, France, 75010
Site IT39004
Castelfranco Veneto (TV), Italy, 31033
Site AR54001
Cordoba, Argentina, X5000JHQ
Site GB44014
Cambridge, United Kingdom
Site IL97201
Rehovot, Israel, 7610001
Site JP81024
Sapporo, Japan
Site FR33009
Mulhouse, France, 68070
Site US10015
Louisville, United States, 40207
Site GR30010
Athens, Greece, 10676
Site GB44005
Bristol, United Kingdom, BS2 8ED
Site TR90001
Kayseri, Turkey, 38039
Site US10019
Augusta, United States, 30912
Site GR30008
Larissa, Greece, 41110
Site GR30001
Rio Patras, Greece, 26504
Site BR55007
Porto Alegre, Brazil
Site TR90012
Izmir, Turkey
Site JP81003
Isehara, Japan
Site KR82002
Seoul, Republic of Korea, 06591
Site FR33004
Brest, France, 29609
Site AU61005
Geelong, Australia, 3220
Site PL48005
Warszawa, Poland, 02-776
Site IL97202
Jerusalem, Israel, 91120
Site RO40005
București, Romania
Site FR33017
Avignon, France, 84902
Site FR33010
Perpignan, France, 66046
Site TR90010
Gaziantep, Turkey
Site AU61002
Southport, Australia, 4215
Site ES34012
Sevilla, Spain, 41014
Site SE46002
Lund, Sweden, 221 85
Site FR33003
Toulouse Cedex 9, France, 31059
Site IT39008
Bergamo, Italy, 24127
Site TR90005
Denizli, Turkey, 20070
Site KR82004
Seoul, Republic of Korea, 05505
Site PT35101
Porto, Portugal, 4200-072
Site RO40002
Targu Mures, Romania, 540136
Site HU36007
Pecs, Hungary, H-7624
Site GB44004
Nottingham, United Kingdom, NG5 1PB
Site US10035
Indianapolis, United States, 46237
Site RO40003
Bucuresti, Romania, 022328
Site RO40006
Craiova, Romania