Last updated on September 2017

An Efficacy and Safety Study of AG-221 (CC-90007) Versus Conventional Care Regimens in Older Subjects With Late Stage Acute Myeloid Leukemia Harboring an Isocitrate Dehydrogenase 2 Mutation


Brief description of study

This is an international, multicenter, open-label, randomized, Phase 3 study comparing the efficacy and safety of AG-221 versus conventional care regimens (CCRs) in subjects 60 years or older with acute myeloid leukemia (AML) refractory to or relapsed after second- or third-line AML therapy and positive for an isocitrate dehydrogenase (IDH2) mutation.

Detailed Study Description

Acute myeloid leukaemia (AML) is a form of cancer that is common in older patients. Mutations in the isocitrate dehydrogenase enzyme 2 (IDH2) have been found in approximately 15% of patients with AML. The outcome of first line chemotherapy treatment is poor and many patients fail to attain complete remission (CR, ie refractory) or will eventually relapse. There is no single standard of care for relapsed or refractory AML. Since the prognosis is very poor there is a great need for new therapies. Inhibition of IDH2 mutations may represent a promising targeted therapy for AML. AG-221 is designed to only block the IDH2 mutations. Data from the ongoing first-in-human study has shown AG-221 to be generally well tolerated and demonstrated CR in patients with IDH2 mutation positive relapsed or refractory AML. The study purpose is to test the safety and efficacy of AG-221 compared with conventional care regimens (CCR), which include best supportive care (BSC) only, azacitidine plus BSC, low-dose cytarabine plus BSC or intermediate-dose cytarabine plus BSC, in patients with late stage AML refractory to or relapsed after second or third line therapy and positive for the IDH2 mutation. Patients will be randomly assigned to receive open-label tablets of AG-221 or one of the CCR on continuous 28-day treatment cycles. The trial duration is expected to be 28 months which includes 24 months enrollment, approximately 4 months treatment and a follow-up period. Study procedures include: vital signs, physical exams, ECGs, ECHO, urine/blood samples, bone marrow aspirates and/or biopsies and peripheral blood to test for IDH2 and assess treatment response. Bone marrow, blood, cheek swab samples will be used for genetic tests. This study is being sponsored by Celgene Corporation. Approximately 280 participants will take part in the study.

Clinical Study Identifier: NCT02577406

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University of Southern California Norris Cancer Center
Los Angeles, CA United States
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UCLA School of Medicine Hematology Oncology
Los Angeles, CA United States
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University of Colorado Cancer Center
Aurora, CO United States
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Yale University School of Medicine
New Haven, CT United States
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Shands Cancer Center University of Florida
Gainesville, FL United States
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University of Miami Sylvester Cancer Research Center
Miami, FL United States
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University of Florida Health Cancer Center at Orlando Health
Orlando, FL United States
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Northwestern University Medical Center Division of Hematology Oncology
Chicago, IL United States
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Rush University Medical Center
Chicago, IL United States
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University of Chicago Medical Center
Chicago, IL United States
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Northshore University Healthsystem Research Institute
Evanston, IL United States
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Massachusetts General Hospital
Boston, MA United States
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John Theurer Cancer Center at Hackensack University Medical Center
Hackensack, NJ United States
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Roswell Park Cancer Institute
Buffalo, NY United States
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Memorial Sloan Kettering Cancer Center
New York, NY United States
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Mount Sinai School of Medicine
New York, NY United States
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Strong Health System
Rochester, NY United States
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Montefiore Medical Center Albert Einstein Cancer Center
The Bronx, NY United States
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Duke University Medical Center
Durham, NC United States
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University Hospitals Cleveland Medical Center
Cleveland, OH United States
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Cleveland Clinic Foundation
Cleveland, OH United States
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Penn State Hershey Medical Center
Hershey, PA United States
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Cancer Center of the Carolinas
Greenville, SC United States
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Sarah Cannon Research Inst
Nashville, TN United States
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Baylor Sammons Cancer Center
Dallas, TX United States
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MD Anderson Cancer Center The University of Texas
Houston, TX United States
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West Virginia University CTRU
Morgantown, WV United States
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Concord Repatriation General Hospital
Concord, Australia
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Royal Adelaide Hospital Institute of Medical and Veterinary Science
Adelaide, Australia
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Peter MacCallum Cancer Centre - East Melbourne
East Melbourne, Australia
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Royal Brisbane Hospital
Herston, Australia
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The Alfred Hospital
Melbourne, Australia
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Royal Prince Alfred Hospital
Sydney, Australia
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Medical University of Graz
Graz, Austria
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Elisabethinen Hospital Linz
Linz, Austria
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Klinik fur Innere Medizin III
Wien, Austria
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AZ St-Jan Brugge Oostende AV
Brugge, Belgium
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Cliniques Universitaires UCL de Mont-Godine
Yvoir, Belgium
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Santa Casa de Porto Alegre
Porto Alegre, Brazil
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Fundacao Hospital Amaral Carvalho
Jau, Brazil
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Hospital de Clinicas de Porto Alegre
Porto Alegre, RS, Brazil
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HEMORIO - Unidade de Pesquisa Cl nica
Rio de Janeiro, Brazil
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Sociedade Beneficente de Senhoras Hospital Sirio Libanes
São Paulo, Brazil
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University of Alberta
Edmonton, AB Canada
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Cancer Care Manitoba
Winnipeg, MB Canada
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Princess Margaret Cancer Centre
Toronto, ON Canada
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McGill University Health Center
Montreal, QC Canada
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The First Hospital of China Medical University
Beijing, China
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Peking University Third Hospital
Beijing, China
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Peking Union Medical College Hospital
Beijing, China
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Chinese PLA General Hospital
Beijing, China
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First Hospital of Jilin University
Changchun, China
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The Third Xiangya hospital of central south university
Changsha, China
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West China Hospital
Chengdu, Sichuan, China
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Fujian Medical University Union Hospital
Fuzhou, China
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Guangdong General Hospital
Guangzhou, Guangdong, China
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The First Affiliated Hospital of Medical School of Zhejiang University
Hangzhou City, China
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Ruijin Hospital Affiliated to Shanghai Jiao Tong University School of Medicine
Shanghai, China
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Tongji Hospital, Tongji Medical College of Huazhong University of Science and Technology
Wuhan, China
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Henan Cancer Hospital
Zhengzhou, China
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Fakultni nemocnice Brno
Brno, Czechia
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Fakultni nemocnice Hradec Kralove
Hradec Kralove, Czechia
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Vseobecna Fakultni Nemocnice v Praze
Praha, Czechia
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Aalborg Universitetshospital
Aalborg, Denmark
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Copenhagen University Hospital Rigshosptalet
Copenhagen, Denmark
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Odense University Hospital
Odense, Denmark
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Hopital Aviecenne
BOBIGNY Cedex, France
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CHU Grenoble
Grenoble Cedex 09, France
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Institut Paoli Calmette Hematologie
Marseille cedex, France
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Centre Hospitalier Lyon Sud
Pierre-Bénite Cedex, France
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Hopital Purpan
Toulouse Cedex, France
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Versailles, France
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Villejuif Cedex, France
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Aachen, Germany
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Universitatsklinikum Carl Gustav Carus an der TU Dresden
Dresden, Germany
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Essen, Germany
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Frankfurt, Germany
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Freiburg, Germany
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Hannover, Germany
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SLK Kliniken Heilbronn GmbH - Klinikum am Gesundbrunnen
Heilbronn, Germany
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Leipzig, Germany
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Universit tsmedizin der Johannes Gutenberg-Universit t Mainz
Mainz, Germany
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München, Germany
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München, Germany
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Robert Bosch Krankenhaus
Stuttgart, Germany
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Tübingen, Germany
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Ulm, Germany
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Policlinico S. Orsola - Malpighi
Bologna, Italy
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AO Spedali Civili di Brescia
Brescia, Italy
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Hematology Dept Azienda Ospedaliero Universitaria Careggi
Firenze, Italy
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Casa di Cura La Maddalena
Palermo, Italy
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Azienda Ospedaliera "Bianchi-Melacrino-Morelli"
Reggio Calabria, Italy
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Fondazione PTV Policlinico Tor Vergata
Roma, Italy
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Ospedale di Circolo di Varese
Varese, Italy
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Hwasun Chonnam National University Hospital
Hwasun-gun, Korea, Republic of
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Seoul National University Hospital
Seoul, Korea, Republic of
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Severance Hospital, Yonsei University Health System
Seoul, Korea, Republic of
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Samsung Medical Center
Seoul, Korea, Republic of
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The Catholic University of Korea Seoul - Saint Mary's Hospital
Seoul, Korea, Republic of
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Krasnoyarsk Regional Clinical Hospital
Krasnoyarsk, Russian Federation
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City Clinical Hospital 52
Moscow, Russian Federation
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City Clinical Hospital 40
Moscow, Russian Federation
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St. Petersburg Research Institute of Hematology and Blood Transfusion
Saint-Petersburg, Russian Federation
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Hospital Universitario La Fe
Avda, Campanar 21, Spain
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Barcelona, Spain
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Barcelona, Spain
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Barcelona, Spain
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Madrid, Spain
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Madrid, Spain
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Oviedo, Spain
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Salamanca, Spain
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Sevilla, Spain
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Taichung, Northern Dist., Taiwan
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Taipei, Zhongzheng Dist., Taiwan
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Chang Gung Medical Foundation-Linkou Branch
Taoyuan, Taiwan
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Hacettepe Universitesi Tip Fakultesi Hastanesi
Ankara, Turkey
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Dr. Abdurrahman Yurtaslan Ankara Onkoloji hospital
Ankara, Turkey
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Ankara, Turkey
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Pamukkale University Medical Faculty
Denizli, Turkey
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Gaziantep University
Gaziantep, Turkey
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Cardiff, United Kingdom
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Queens Centre for Oncology & Haematology
Hull, United Kingdom
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St Bart's London
London, United Kingdom
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London, United Kingdom
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Christie Hospital NHS Trust
Manchester Withington, United Kingdom
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Nottingham City Hospital
Nottingham, United Kingdom
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John Radcliffe Hospital The Oxford Radcliffe Hospital Clinical Haematology
Oxford, United Kingdom
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Sheffield South Yorkshire, United Kingdom
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Sidcup, United Kingdom
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Spire Little Aston Hospital
West Midlands, United Kingdom
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