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

Recruitment complete
The study is ongoing, and participants are receiving an intervention or being examined, but potential participants are not currently being recruited or enrolled. ID

The unique identification code given to each clinical study upon registration at

Astellas Study ID

The unique identification code given by the study sponsor.


EudraCT ID

The unique identification code given to each clinical study upon registration at EudraCT (European Union Drug Regulating Authorities Clinical Trials Database).



Leukemia - AML


These clinical trials are done to confirm that an experimental treatment helps participants who have a specific condition. These clinical trials often compare the experimental treatment to another treatment or, if appropriate, a placebo.

Phase 3


18 years - N/A


Female & Male




A type of clinical study in which participants are assigned to groups that receive one or more intervention/treatment (or no intervention) so that researchers can evaluate the effects of the interventions on biomedical or health-related outcomes.


Trial Dates

Aug 2016 - Jun 2024


None (Open Label)

Enrollment number


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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Would you like more information about clinical trial sites that are recruiting participants for 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? Contact us by filling our your information to the right and we’ll respond to you.

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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