Study Details
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
Clinicaltrials.gov ID
Astellas Study ID
2215-CL-0201
EudraCT ID
2015-001790-41
Condition
Leukemia - AML
Phase
Phase 3
Age
18 years - N/A
Sex
Female & Male
Product
gilteritinib
Type
Interventional
Trial Dates
Aug 2016 - Jun 2024
Masking
None (Open Label)
Enrollment number
183
A Phase 3 Multicenter, Open-label, Randomized Study of ASP2215 (Gilteritinib), Combination of ASP2215 Plus Azacitidine and Azacitidine Alone in the Treatment of Newly Diagnosed Acute Myeloid Leukemia with FLT3 Mutation in Patients Not Eligible for Intensive Induction Chemotherapy
Study summary
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Locations
Site PL48005
Krakow, Poland, 31-501
The University of Texas MD Anderson Cancer Center
Houston, United States, 77030
Site DE49004
Hannover, Germany, 30625
Site JP81019
Toyama, Japan
Site FR33016
Limoges, France, 87042
Eastern Maine Medical Center - CancerCare of Maine
Brewer, United States, 04412
Orlando Health Inc - Clinic
Orlando, United States, 32806
Site KR82008
Seoul, Republic of Korea, 06351
Site JP81015
Kobe, Japan
Site CA15009
Edmonton, Canada, T6G 2B7
St. Louis University Cancer Center - Hematology/Oncology
St. Louis, United States, 63110
Site BE32006
Gent, Belgium, 9000
Weill Cornell Medical College-New York Presbyterian Hospital
New York, United States, 10021
Site TW88602
Tainan, Taiwan, Province of China, 704
Site JP81031
Sapporo, Japan
Site FR33001
Nantes cedex 01, France, 44093
Site JP81005
Kumamoto, Japan
Site DE49011
Stuttgart, Germany, 70376
Site AU61004
Liverpool, Australia, 2170
Rush University Medical Center
Chicago, United States, 60612
Site TW88609
Tainan, Taiwan, Province of China, 736
Site GB44004
London, United Kingdom, EC1A 7BE
Site JP81027
Matsuyama, Japan
Site FR33009
Angers, France, 49033
Site FR33017
Le Mans, France, 72037
Site TW88601
Taipei, Taiwan, Province of China, 10002
Site ES34013
Madrid, Spain
Site JP81021
Fukuyama, Japan
UCLA David Geffen School of Medicine
Los Angeles, United States, 90095
Site JP81006
Sapporo, Japan
Site FR33019
Montpellier Cedex 5, France, 34295
Site TW88605
Kwei Shan Hsiang, Taiwan, Province of China
Site FR33022
Paris Cedex 10, France, 75475
Site JP81003
Yokohama, Japan
Site KR82003
Namdong, Republic of Korea, 405 760
Site DE49009
Halle (Saale), Germany, 06120
Site JP81017
Nagasaki, Japan
Site JP81032
Yokohama, Japan
University of Florida
Gainesville, United States, 32610-0278
Site JP81011
Kurashiki, Japan
Site JP81030
Osaka, Japan
Site AU61008
Adelaide, Australia, SA 5000
Hematology-Oncology Associates of Northern NJ
Morristown, United States, 07962
Indiana Blood Marrow Transplantation
Indianapolis, United States, 46237
Site KR82006
Seoul, Republic of Korea, 110-744
Site BE32007
Brussel, Belgium, 1090
Site DE49012
Braunschweig, Germany, 38118
Site PL48001
Olsztyn, Poland, 10-228
Baylor Research Institute
Dallas, United States, 75246
Site ES34005
Valencia, Spain, 46026
Site FR33005
Amiens, France, 80054
Mount Sinai Downtown Union Square
New York, United States, 10003
Site IT39012
Firenze, Italy
Site KR82015
Seongnam-si, Republic of Korea
SUNY Upstate Medical University
Syracuse, United States, 13210
Manhattan Hematology Oncology Associates, P.C.
New York, United States, 10016
Site FR33007
Le Chesnay Cedex, France, 78157
Site IT39005
Pavia, Italy
GHS Cancer Institute
Greenville, United States, 26615
Site ES34002
CACERES, Spain, 10003
Site CA15002
Toronto, Canada, M5G 2M9
Site KR82013
Seoul, Republic of Korea, 05505
Site DE49007
Munchen, Germany, 81737
Site JP81016
Kyoto, Japan
Site IT39011
San Giovanni Rotondo, Italy, 71013
Site DE49005
Frankfurt, Germany, 60590
Site FR33003
Nimes Cedex 09, France, 30029
Site PL48003
Lublin, Poland, 20-081
Site ES34012
Valladolid, Spain
Robert H. Lurie Comprehensive Cancer Center
Chicago, United States, 60611-5975
Augusta University - Georgia Cancer Center
Augusta, United States, 30912
Site TW88610
Taipei, Taiwan, Province of China, 11217
Site FR33013
Pierre-Benite, France, 69310
Site BE32008
Montigny-le-Tilleul, Belgium, 6110
Site AU61012
Camperdown, Australia, 2050
Site ES34003
Oviedo, Spain, 33011
Site IT39004
Milano, Italy, 20162
Site TW88604
Kaohsiung, Taiwan, Province of China, 83301
Site PL48002
Opole, Poland, 45-061
Memorial Sloan-Kettering Cancer Center
New York, United States, 10021
Site JP81012
Sendai, Japan
Site IT39009
Ancona, Italy, 60126
Site JP81029
Shibuya-ku, Japan
Site IT39007
Monza, Italy
University of Chicago
Chicago, United States, 60637
Site FR33006
Lille, France, 59037
Site ES34010
Barcelona, Spain, 08036
Site CA15004
Halifax, Canada, B3H 2Y9
Site TW88608
Taipei, Taiwan, Province of China, 10449
Site JP81023
Kanazawa, Japan
Site FR33015
Rouen, France, 76038
Site BE32003
Bruxelles, Belgium, 1200
Site JP81014
Shinagawa-ku, Japan
Site DE49002
Tuebingen, Germany, 72076
University of Southern California
Los Angeles, United States, 90033
Site JP81007
Nagoya, Japan
Site JP81010
Maebashi, Japan
Site GB44007
Sheffield, United Kingdom, S10 2JF
Site ES34004
Barcelona, Spain, 08035
Site FR33002
Pessac, France, 33604
Site PL48004
Warszawa, Poland, 02-776
Site JP81018
Anjo, Japan
Yale-New Haven Hospital (YNHH) - Smilow Cancer Hospital
New Haven, United States, 06510-3220
LDS Hospital
Salt Lake City, United States, 84143
Site DE49015
Rostock, Germany, 18057
Roswell Park Cancer Institute
Buffalo, United States, 14263
Site JP81026
Tokushima, Japan
Site IT39014
Novara, Italy
Site DE49013
Heilbronn, Germany, 74078
Site KR82001
Ulsan, Republic of Korea, 682-714
Hackensack University Medical Center - John Theurer Cancer Center
Hackensack, United States, 07601
Swedish Cancer Institute / Swedish Health Services
Seattle, United States, 98104
Norton Cancer Institute
Louisville, United States, 40207
Site CA15006
Montreal, Canada, H4A 3J1
Site IT39006
Palermo, Italy, 90146
Medical City Dallas Hospital
Dallas, United States, 75230
Site KR82010
Hwasun-gun, Republic of Korea
Site JP81036
Osaka, Japan
Loyola University Medical Center
Maywood, United States, 60153
Site KR82002
Seoul, Republic of Korea, 137-701
Site KR82012
Seoul, Republic of Korea, 156-707
University of California, Irvine Medical Center
Orange, United States, 92868
Tulane University Health Sciences Center
New Orleans, United States, 70112
Site FR33018
Rennes, France, 35033
Site FR33023
Valenciennes, France, 59322
Site FR33004
Lille cedex, France, 59020
Site ES34011
Coruna, Spain, 15006
Site DE49008
Bonn, Germany, 53105
Penn State Hershey Cancer Institute
Hershey, United States, 17033-0850
Site JP81033
Sapporo, Japan
Site AU61007
Geelong, Australia, 3220
Site JP81008
Fukuoka, Japan
Site KR82014
Busan, Republic of Korea, 49241
Site IT39001
Napoli, Italy, 80131
Site JP81035
Chiba, Japan
Site JP81024
Gifu, Japan
Site JP81004
Nagasaki, Japan
Site JP81037
Kyoto, Japan
Site IT39002
Varese, Italy
Site IT39003
Milano, Italy
Site CA15011
Toronto, Canada, M4N 3M5
University of Oklahoma Health Sciences Center
Oklahoma City, United States, 73104
Site JP81001
Isehara, Japan
Site JP81034
Hitachi, Japan
Site FR33014
Vandoeuvre les Nancy, France, 54500
Site JP81022
Tachikawa, Japan
Site FR33020
Bayonne, France
Site IT39015
Bologna, Italy, 40138
Site DE49003
Berlin, Germany, 13353
Site ES34008
Barcelona, Spain, 08003
Site FR33012
Poitiers, France, 86000
Site ES34007
Palma de Mallorca, Spain, 07010
Site ES34009
Barcelona, Spain, 8041
Site TW88607
Taichung, Taiwan, Province of China, 40705