Study Details

A Study of ASP2215 versus Salvage Chemotherapy in Patients with Relapsed or Refractory Acute Myeloid Leukemia (AML) with FMS-like tyrosine kinase (FLT3) Mutation

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.

Clinicaltrials.gov ID

The unique identification code given to each clinical study upon registration at ClinicalTrials.gov.
NCT02421939

Astellas Study ID

The unique identification code given by the study sponsor.

2215-CL-0301

EudraCT ID

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

2015-000140-42

Condition

Leukemia - AML

Phase

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

Age

18 years - N/A

Sex

Female & Male

Product

gilteritinib

Type

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.

Interventional

Trial Dates

Oct 2015 - Jul 2024

Masking

None (Open Label)

Enrollment number

371

A Phase 3 Open-Label, Multicenter, Randomized Study of ASP2215 versus Salvage Chemotherapy in Patients with Relapsed or Refractory Acute Myeloid Leukemia (AML) with FLT3 Mutation

Study summary

Get More Information

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Locations

Site US10083

Evanston, United States, 60201

Site US10058

Oklahoma City, United States, 73104

Site JP81024

Okayama, Japan

Site FR33002

Le Chesnay Cedex, France, 78157

Site PL48004

Wroclaw, Poland, 50-367

Site US10001

Buffalo, United States, 14263

Site US10006

Chicago, United States, 60637

Site CA15004

Edmonton, Canada, T6G 2G3

Site US10087

Detroit, United States, 48201

Site TW88602

Taipei, Taiwan, Province of China, 114

Site US10085

Boston, United States, 02215

Site IL97209

Haifa, Israel, 31096

Site ES34014

Salamanca, Spain, 37007

Site TR90008

Izmir, Turkey, 35340

Site JP81026

Yoshida-gun, Japan

Site ES34009

Badalona, Spain, 08025

Site KR82004

Seoul, Republic of Korea, 120-752

Site GB44015

Plymouth, United Kingdom, PL6 8DH

Site FR33013

Brest, France, 29609

Site US10007

Houston, United States, 77030

Site US10046

Syracuse, United States, 13210

Site US10010

Philadelphia, United States, 19104

Site JP81004

Shinagawa-ku, Japan

Site US10041

Hershey, United States, 17033

Site CA15001

Hamilton, Canada, L8V 1C3

Site GB44003

Manchester, United Kingdom, M13 9WL

Site GB44013

Harrow, United Kingdom, HA1 3UJ

Site FR33009

Pessac, France, 33604

Site US10057

Minneapolis, United States, 55455

Site IL97203

Jerusalem, Israel, 91031

Site TW88601

Tainan, Taiwan, Province of China, 704

Site DE49004

Wurzburg, Germany, 97070

Site US10037

New York, United States, 10029

Site IT39011

Pavia, Italy, 27100

Site TW88611

Taipei, Taiwan, Province of China, 112

Site PL48003

Slupsk, Poland, 76-200

Site TW88609

Taichung City, Taiwan, Province of China, 40705

Site US10076

Orange, United States, 92868

Site DE49003

Marburg, Germany, 35043

Site JP81022

Shinjuku-ku, Japan

Site US10024

Durham, United States, 27710

Site US10044

Cleveland, United States, 44106

Site BE32008

Bruxelles, Belgium, 1000

Site US10084

Columbus, United States, 43210

Site US10080

Philadelphia, United States, 19107

Site ES34011

Barcelona, Spain, 08035

Site US10079

Stony Brook, United States, 11794

Site TR90004

Ankara, Turkey, 06500

Site JP81007

Kurashiki, Japan

Site US10086

Chicago, United States, 60637

Site US10063

Nashville, United States, 37232-0656

Site IT39007

Roma, Italy, 00189

Site DE49002

Munchen, Germany, 81737

Site ES34005

L'Hospitalet de Llobregat, Spain, 08907

Site US10078

Winston-Salem, United States, 27157

Site JP81002

Nagoya, Japan

Site US10023

Lebanon, United States, 03756-1000

Site JP81012

Sendai, Japan

Site JP81006

Yokohama, Japan

Site JP81016

Sapporo, Japan

Site US10011

Birmingham, United States, 35294-0006

Site US10081

Atlanta, United States, 30342

Site KR82011

Seoul, Republic of Korea, 156-707

Site JP81025

Kyoto, Japan

Site ES34015

Madrid, Spain, 28006

Site US10077

New Brunswick, United States, 08903

Site US10073

San Francisco, United States, 94143

Site JP81023

Akita, Japan

Site IL97201

Ashkelon, Israel, 78278

Site US10034

Boston, United States, 02114

Site ES34012

Barcelona, Spain, 08036

Site IL97210

Jerusalem, Israel, 91120

Site BE32001

Brugge, Belgium, 8000

Site JP81011

Osaka, Japan

Site BE32002

Yvoir, Belgium, 5530

Site IT39004

Palermo, Italy, 90146

Site TW88604

Kaohsiung, Taiwan, Province of China, 83301

Site DE49010

Tubingen, Germany, 72076

Site IT39002

Varese, Italy, 21100

Site JP81001

Fukuoka, Japan

Site KR82008

Seoul, Republic of Korea, 138-736

Site KR82003

Jeollanam-do, Republic of Korea, 519-809

Site CA15015

Toronto, Canada, M5G 2M9

Site JP81027

Shimotsuke, Japan

Site DE49011

Leipzig, Germany, 04103

Site FR33011

Angers, France, 49000

Site IT39001

Milan, Italy, 20132

Site BE32010

Antwerp, Belgium, 2060

Site IE35304

Dublin, Ireland, 9

Site KR82010

Busan, Republic of Korea, 602739

Site US10072

New York, United States, 10065

Site KR82009

Goyang, Republic of Korea, 602-715

Site TW88603

Taipei, Taiwan, Province of China, 10002

Site KR82005

Suwon-si, Republic of Korea, 443380

Site US10022

Boston, United States, 02215

Site US10027

Hackensack, United States, 07601

Site CA15016

Montreal, Canada, H3H 2R9

Site US10005

Baltimore, United States, 21201

Site IL97208

Rehovot, Israel, 76100

Site KR82002

Seoul, Republic of Korea, 137701

Site CA15003

Montreal, Canada, H1T 2M4

Site US10045

Gainesville, United States, 32610

Site JP81005

Chuo-ku, Japan

Site JP81003

Maebashi, Japan

Site IT39010

Brescia, Italy, 25126

Site US10012

Los Angeles, United States, 90095-1752

Site US10033

Maywood, United States, 60153

Site JP81021

Aomori, Japan

Site TR90001

Ankara, Turkey, 06100

Site JP81014

Osakasayama, Japan

Site KR82001

Seoul, Republic of Korea, 135710

Site JP81008

Nagasaki, Japan

Site FR33010

Lille, France, 59037

Site PL48002

Gdansk, Poland, 80-952

Site JP81009

Isehara, Japan

Site US10013

New York, United States, 10065

Site FR33008

Toulouse, France, 31059

Site ES34017

Valencia, Spain, 46026

Site US10067

New Haven, United States, 06504

Site PL48005

Opole, Poland, 45-372

Site ES34010

Barcelona, Spain, 08916

Site US10075

Westwood, United States, 66205

Site KR82007

Seoul, Republic of Korea, 110-744

Site TW88610

Taipei, Taiwan, Province of China, 10449

Site TW88606

Kaohsiung, Taiwan, Province of China, 112

Site GB44014

Bournemouth, United Kingdom, BH7 7DW

Site DE49009

Dresden, Germany, 01307

Site JP81018

Kobe, Japan

Site ES34016

Girona, Spain, 17007

Site US10008

New York, United States, 10032

Site US10048

New Orleans, United States, 70112

Site JP81010

Narita, Japan

Site US10014

Charleston, United States, 29425

Site JP81017

Tsukuba, Japan

Site US10074

Louisville, United States, 40202

Site IT39005

Bologna, Italy, 40138

Site JP81013

Kumamoto, Japan

Site FR33014

Rennes, France, 35033

Site US10035

Milwaukee, United States, 53226

Site TW88608

Taichung, Taiwan, Province of China, 404

Site TW88605

Taoyuan, Taiwan, Province of China, 33305

Site IL97206

Petah Tikva, Israel, 49100

Site JP81020

Kawagoe, Japan

Site US10054

Worcester, United States, 01655