Last updated on May 2019

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


Brief description of study

The purpose of this study is to compare relapse-free survival (RFS) between subjects with FMS-like tyrosine kinase 3 (FLT3) / internal tandem duplication (ITD) acute myeloid leukemia (AML) in first complete remission (CR1) and who are randomized to receive gilteritinib or placebo beginning after completion of induction/consolidation chemotherapy for a two-year period.

Detailed Study Description

Subjects in CR1 will be approached for this study after induction/consolidation therapy is complete and a decision not to proceed with transplantation is made or a suitable donor could not be identified. Subjects will be randomized in a 2:1 ratio to receive gilteritinib or placebo. Subjects will enter the screening period up to 14 days prior to the start of treatment. Subjects will be administered treatment over continuous 28-day cycles. After treatment discontinuation, subjects will have a 30-day follow-up visit for safety, after which the subjects will enter the long-term follow up period for collection of subsequent AML treatment, remission status, and survival (cause of death and date of death). Gilteritinib or placebo will be given daily for up to 2 years. Subjects will be followed for up to 3 years from the subjects 30-day follow up, or until 80% of the subjects have an RFS event, whichever comes first. Study drug will not be provided during the follow-up period.

Clinical Study Identifier: NCT02927262

Find a site near you

Start Over

Site US10013

Los Angeles, CA United States
  Connect »

Site US10023

Whittier, CA United States
  Connect »

Site US10017

Gainesville, FL United States
  Connect »

Site US10030

Jacksonville, FL United States
  Connect »

Site US10019

Augusta, GA United States
  Connect »

Site US10012

Chicago, IL United States
  Connect »

Site US10035

Indianapolis, IN United States
  Connect »

Site US10015

Louisville, KY United States
  Connect »

Site US10026

Boston, MA United States
  Connect »

Site US10004

Detroit, MI United States
  Connect »

Site US10024

Hawthorne, NY United States
  Connect »

Site US10018

New York, NY United States
  Connect »

Site US10028

New York, NY United States
  Connect »

Site US10025

Syracuse, NY United States
  Connect »

Site US10002

Durham, NC United States
  Connect »

Site US10001

Winston-Salem, NC United States
  Connect »

Site US10022

Canton, OH United States
  Connect »

Site US10007

Portland, OR United States
  Connect »

Site US10020

Charleston, SC United States
  Connect »

Site US10029

Greenville, SC United States
  Connect »

Site US10009

Fairfax, VA United States
  Connect »

Site US10031

Seattle, WA United States
  Connect »

Site AR54003

Buenos Aires, Argentina
  Connect »

Site AR54002

Ciudad Autonoma de Buenos Aires, Argentina
  Connect »

Site AR54001

Cordoba, Argentina
  Connect »

Site AU61006

Liverpool, Australia
  Connect »

Site AU61002

Southport, Australia
  Connect »

Site AU61005

Geelong, Australia
  Connect »

Site BR55002

Goiania, Brazil
  Connect »

Site BR55004

Barretos, Brazil
  Connect »

Site BR55003

Campinas, Brazil
  Connect »

Site BR55007

Porto Alegre, Brazil
  Connect »

Site BR55005

Sao Paulo, Brazil
  Connect »

Site CA15001

Halifax, NS Canada
  Connect »

Site CA15003

Toronto, ON Canada
  Connect »

Site CA15005

Montreal, QC Canada
  Connect »

Site CA15004

Regina, SK Canada
  Connect »

Site HR38502

Zagreb, Croatia
  Connect »

Site HR38501

Zagreb, Croatia
  Connect »

Site CZ42001

Ostrava-Poruba, Czechia
  Connect »

Site DK45003

Odense, Denmark
  Connect »

Site DK45001

Copenhagen, Denmark
  Connect »

Site FR33016

Aix-en-Provence cedex, France
  Connect »

Site FR33003

Toulouse Cedex 9, France
  Connect »

Site FR33002

Tours cedex 01, France
  Connect »

Site FR33010

Perpignan, France
  Connect »

Site FR33014

Vandoeuvre les Nancy, France
  Connect »

Site FR33017

Avignon, France
  Connect »

Site FR33007

Pierre-Benite, France
  Connect »

Site FR33018

Argenteuil, France
  Connect »

Site FR33001

Bayonne, France
  Connect »

Site FR33009

Mulhouse, France
  Connect »

Site FR33008

Nice Cedex 2, France
  Connect »

Site FR33013

Strasbourg, France
  Connect »

Site FR33012

Valenciennes, France
  Connect »

Site DE49009

Rostock, Germany
  Connect »

Site DE49001

Duisburg, Germany
  Connect »

Site DE49005

Greifswald, Germany
  Connect »

Site DE49008

Stuttgart, Germany
  Connect »

Site GR30001

Rio Patras, Greece
  Connect »

Site GR30002

Alexandroupolis, Greece
  Connect »

Site GR30004

Thessaloniki, Greece
  Connect »

Site GR30008

Larissa, Greece
  Connect »

Site GR30007

Larissa, Greece
  Connect »

Site HU36006

Szeged, Hungary
  Connect »

Site HU36003

Nyiregyhaza, Hungary
  Connect »

Site HU36001

Budapest, Hungary
  Connect »

Site HU36004

Debrecen, Hungary
  Connect »

Site IL97202

Jerusalem, Israel
  Connect »

Site IL97201

Rehovot, Israel
  Connect »

Site IL97205

Jerusalem, Israel
  Connect »

Site IT39004

Castelfranco Veneto (TV), Italy
  Connect »

Site IT39010

Reggio Emilia, Italy
  Connect »

Site JP81025

Matsuyama, Japan
  Connect »

Site JP81002

Yoshida-gun, Japan
  Connect »

Site JP81007

Maebashi, Japan
  Connect »

Site JP81004

Kanazawa, Japan
  Connect »

Site JP81009

Yokohama, Japan
  Connect »

Site JP81013

Kurashiki, Japan
  Connect »

Site JP81023

Shimotsuke, Japan
  Connect »

Site JP81008

Shinagawa-ku, Japan
  Connect »

Site JP81011

Tachikawa, Japan
  Connect »

Site JP81016

Nagasaki, Japan
  Connect »

Site KR82005

Suwon-si, Korea, Republic of
  Connect »

Site KR82014

Bucheon-Si, Korea, Republic of
  Connect »

Site KR82013

Goyang, Korea, Republic of
  Connect »

Site KR82008

Namdong, Korea, Republic of
  Connect »

Site KR82003

Hwasungun, Korea, Republic of
  Connect »

Site KR82012

Seoul, Korea, Republic of
  Connect »

Site KR82007

Seoul, Korea, Republic of
  Connect »

Site KR82006

Busan, Korea, Republic of
  Connect »

Site KR82004

Seoul, Korea, Republic of
  Connect »

Site KR82002

Seoul, Korea, Republic of
  Connect »

Site KR82009

Seoul, Korea, Republic of
  Connect »

Site KR82001

Ulsan, Korea, Republic of
  Connect »

Site PL48003

Warszawa, Poland
  Connect »

Site PL48001

Olsztyn, Poland
  Connect »

Site PL48002

Bydgoszcz, Poland
  Connect »

Site PL48005

Warszawa, Poland
  Connect »

Site PT35106

Coimbra, Portugal
  Connect »

Site PT35103

Lisboa, Portugal
  Connect »

Site PT35101

Porto, Portugal
  Connect »

Site RO40003

Bucuresti, Romania
  Connect »

Site RO40002

Targu Mures, Romania
  Connect »

Site RO40004

Bucuresti, Romania
  Connect »

Site RS38101

Belgrade, Serbia
  Connect »

Site RS38102

Belgrade, Serbia
  Connect »

Site ES34001

L'Hospitalet de Llobregat, Spain
  Connect »

Site ES34010

Pamplona, Spain
  Connect »

Site ES34006

Valladolid, Spain
  Connect »

Site SE46001

Linkoeping, Sweden
  Connect »

Site SE46003

Stockholm, Sweden
  Connect »

Site TW88601

Kweishan Hsiang, Taiwan
  Connect »

Site TW88605

Kaohsiung, Taiwan
  Connect »

Site TW88604

Kaohsiung, Taiwan
  Connect »

Site TW88606

Taichung, Taiwan
  Connect »

Site TR90005

Denizli, Turkey
  Connect »

Site TR90002

Istanbul, Turkey
  Connect »

Site TR90001

Kayseri, Turkey
  Connect »

Site GB44019

Plymouth, United Kingdom
  Connect »

Site GB44006

Cottingham, United Kingdom
  Connect »

Site GB44018

London, United Kingdom
  Connect »

Site GB44002

Birmingham, United Kingdom
  Connect »

Site GB44005

Bristol, United Kingdom
  Connect »

Site GB44015

Cardiff, United Kingdom
  Connect »

Site GB44020

Leeds, United Kingdom
  Connect »

Site GB44017

West Midlands, United Kingdom
  Connect »

Site GB44007

Exeter, United Kingdom
  Connect »

Site GB44012

Leicester, United Kingdom
  Connect »

Site GB44011

Manchester, United Kingdom
  Connect »

Site GB44008

Manchester, United Kingdom
  Connect »

Site GB44004

Nottingham, United Kingdom
  Connect »

Site ES34004

La Laguna-Sta.Cruz De Tenerife, Spain
  Connect »

Site GB44003

Middlesex, United Kingdom
  Connect »

Recruitment Status: Open


Brief Description Eligibility Contact Research Team


Receive Emails About New Clinical Trials!

Sign up for our FREE service to receive email notifications when clinical trials are posted in the medical category of interest to you.