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

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.
NCT02927262

Astellas Study ID

The unique identification code given by the study sponsor.

2215-CL-0302

EudraCT ID

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

2016-001643-39

Condition

Leukemia - AML

Phase

These clinical trials are done to learn if an experimental treatment helps participants who have a specific condition or disease. Phase 2 trials usually include a larger group of participants than Phase 1 trials.

Phase 2

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

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

Get More Information

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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