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Brief Title: SGI-110 in Adults With Untreated Acute Myeloid Leukemia (AML), Not Considered Candidates for Intensive Remission Induction
Official Title: A Phase 3, Multicenter, Open-label, Randomized Study of SGI-110 Versus Treatment Choice (TC) in Adults With Previously Untreated Acute Myeloid Leukemia (AML) Who Are Not Considered Candidates for Intensive Remission Induction Chemotherapy
Study ID: NCT02348489
Brief Summary: To compare efficacy and safety between SGI-110 and Treatment Choice in adults with previously untreated AML who are not considered candidates for intensive remission induction chemotherapy.
Detailed Description:
Minimum Age: 18 Years
Eligible Ages: ADULT, OLDER_ADULT
Sex: ALL
Healthy Volunteers: No
Mayo Clinic Cancer Center, Scottsdale, Arizona, United States
Scripps Cancer Center, La Jolla, California, United States
University of Southern California, Los Angeles, California, United States
University of Chicago, Chicago, Illinois, United States
University of Kansas Medical Center, Westwood, Kansas, United States
University of Minnesota Medical Center, Minneapolis, Minnesota, United States
Mayo Clinic Cancer Center, Rochester, Minnesota, United States
John Theurer Cancer Center at Hackensack, Hackensack, New Jersey, United States
University of New Mexico Cancer Center, Albuquerque, New Mexico, United States
Roswell Park Cancer Institute, Buffalo, New York, United States
Weill Cornell Medical College, New York, New York, United States
Columbia University Medical Center, New York, New York, United States
Stony Brook University Medical Center, Stony Brook, New York, United States
Duke Cancer Center, Durham, North Carolina, United States
University Hospitals of Cleveland, Cleveland, Ohio, United States
University Hospitals Monarch Medical Center, Cleveland, Ohio, United States
Penn State Milton S. Hershey Medical Center, Hershey, Pennsylvania, United States
Temple University, Philadelphia, Pennsylvania, United States
Western Pennsylvania Hospital, Pittsburgh, Pennsylvania, United States
Vanderbilt University Medical Center, Nashville, Tennessee, United States
MD Anderson Cancer Center, Houston, Texas, United States
University of Wisconsin, Madison, Wisconsin, United States
Medical College of Wisconsin, Milwaukee, Wisconsin, United States
Concord Repatriation General Hospital, Concord, New South Wales, Australia
Royal Adelaide Hospital, Adelaide, South Australia, Australia
Monash Medical Centre, Clayton, Victoria, Australia
Austin Health, Heidelberg, Victoria, Australia
Medizinische Universität Graz, Graz, Styria, Austria
Hanusch Krankenhaus Wiener Gebietskrankenkasse, Wien, Vienna, Austria
Grand Hôpital de Charleroi, Charleroi, Hainaut, Belgium
UZ Gent, Ghent, Oost-vlaanderen, Belgium
Algemeen Ziekenhuis Sint-Jan, Brugge, West-vlaanderen, Belgium
UMHAT 'Sveti Georgi' EAD, Plovdiv, , Bulgaria
Multiprofile Hospital for Active Treatment "Sveta Marina'' EAD, Varna, , Bulgaria
Tom Baker Cancer Center, Calgary, Alberta, Canada
University of Alberta Hospital, Edmonton, Alberta, Canada
Vancouver General Hospital, Vancouver, British Columbia, Canada
The Ottawa Hospital, Ottawa, Ontario, Canada
Princess Margaret Hospital, Toronto, Ontario, Canada
Sunnybrook Health Sciences Centre, Toronto, Ontario, Canada
Fakultní nemocnice Brno, Brno, Jihormoravsky KRAJ, Czechia
Všeobecná fakultní nemocnice v Praze, Praha 2, Praha, Czechia
Fakultní nemocnice Královské Vinohrady, Praha 10, , Czechia
Aarhus University Hospital, Aarhus, , Denmark
Rigshospitalet-Copenhagen University Hospital, Copenhagen, , Denmark
Odense University Hospital, Odense, , Denmark
Tampere University Hospital, Tampere, Southern Finland, Finland
Helsinki University Central Hospital, Helsinki, , Finland
GHR Mulhouse Sud-Alsace, Mulhouse Cedex, Alsace, France
Hôpital Hôtel-Dieu, Bayonne, Aquitaine, France
Centre Henri-Becquerel, Rouen Cedex 1, Haute-normandie, France
Hôpital Saint Louis, Paris Cedex 10, Ile-de-france, France
CHRU de Limoges - Hôpital Dupuytren, Limoges Cedex, Limousin, Lorraine, France
Centre Hospitalier Universitaire de Toulouse, Toulouse cedex 9, Midi-pyrenees, France
Hôpital Hôtel-Dieu, Nantes cedex 1, PAYS DE LA Loire, France
Institut Paoli Calmettes, Marseille Cedex 9, Provence Alpes COTE D'azur, France
Centre Antoine Lacassagne, Nice, Provence Alpes COTE D'azur, France
Centre Hospitalier Universitaire Grenoble, La Tronche, Rhone-alpes, France
Centre Léon Bérard, Lyon Cedex 08, Rhone-alpes, France
Centre Hospitalier Lyon Sud, Pierre Bénite Cedex, Rhone-alpes, France
Universitaetsklinikum Freiburg, Freiburg, Baden-wuerttemberg, Germany
Universitätsklinikum Ulm, Ulm, Baden-wuerttemberg, Germany
Schwarzwald-Baar Klinikum Villingen-Schwenningen GmbH, Villingen-Schwenningen, Baden-wuerttemberg, Germany
Universitätsklinikum Frankfurt Goethe Universität, Frankfurt am Main, Hessen, Germany
Städtisches Klinikum Braunschweig gGmbH, Braunschweig, Niedersachsen, Germany
Marien Hospital Düsseldorf GmbH, Düsseldorf, Nordrhein-westfalen, Germany
Universitätsklinikum Schleswig-Holstein, Kiel, Schleswig-holstein, Germany
Bacs-Kiskun Megyei Korhaz, Kecskemét, Bacs-kiskun, Hungary
Semmelweis Egyetem, Budapest, , Hungary
Debreceni Egyetem Klinikai Kozpont, Debrecen, , Hungary
Somogy Megyei Kaposi Mór Oktató Kórház, Kaposvár, , Hungary
Azienda Ospedaliera Ospedali Riuniti Marche Nord, Pesaro, Pesaro E Urbino, Italy
IRCCS Centro di Riferimento Oncologico di Basilicata di Rionero in Vulture, Rionero in Vulture, Potenza, Italy
Azienda Ospedaliero-Univesitaria San Luigi Gonzaga, Orbassano, Torino, Italy
Azienda Ospedaliera SS. Antonio E. Biagio E. Cesare Arrigo di Alessandria, Alessandria, , Italy
Azienda Ospedaliero-Universitaria di Bologna - Policlinico S.Orsola-Malpighi, Bologna, , Italy
Azienda Ospedaliera Ospedale di Busto Arsizio, Busto Arsizio, , Italy
Azienda Ospedaliera-Universitaria Vittorio Emanuele-Ferrarotto-Santo Bambino, Catania, , Italy
IRCCS Azienda Ospedaliera Universitaria San Martino - IST, Genova, , Italy
Fondazione IRCCS Cà Granda Ospedale Maggiore Policlinico, Milano, , Italy
Azienda Ospedaliero-Universitaria Policlinico di Modena, Modena, , Italy
AORN A. Cardarelli, Napoli, , Italy
Azienda Policlinico Umberto I di Roma, Roma, , Italy
Azienda Ospedaliero Universitaria S. Maria della Misericordia di Udine, Udine, , Italy
, Chubu, , Japan
, Chugoku, , Japan
, Kanto, , Japan
, Kinki, , Japan
, Kyushu, , Japan
, Tohoku, , Japan
Seoul National University Bundang Hospital, Seongnam-si, Gyeonggi-do, Korea, Republic of
Chonnam National University Hwasun Hospital, Hwasun, Jeollanam-do, Korea, Republic of
Seoul National University Hospital, Jongno Gu, Seoul, Korea, Republic of
Inje University Busan Paik Hospital, Busan, , Korea, Republic of
Kyungpook National University Hospital, Daegu, , Korea, Republic of
Asan Medical Center, Seoul, , Korea, Republic of
Samsung Medical Center, Seoul, , Korea, Republic of
Seoul Saint Mary's Hospital, Seoul, , Korea, Republic of
Severance Hospital, Yonsei University Health System, Seoul, , Korea, Republic of
Ulsan University Hospital, Ulsan, , Korea, Republic of
Universitair Medisch Centrum Utrecht, Utrecht, , Netherlands
Samodzielny Publiczny Szpital Kliniczny Nr 1 we Wroclawiu, Wroclaw, Dolnoslaskie, Poland
Wojewodzki Szpital Specjalistyczny im. M. Kopernika, Lódz, Lodzkie, Poland
Samodzielny Publiczny Szpital Kliniczny nr 1 w Lublinie, Lublin, Lubelskie, Poland
Instytut Hematologii i Transfuzjologii, Warszawa, Mazowieckie, Poland
Samodzielny Publiczny Centralny Szpital Kliniczny, Warszawa, Mazowieckie, Poland
Szpital Wojewódzki w Opolu - Samodzielny Publiczny Zaklad Opieki Zdrowotnej, Opole, Opolskie, Poland
Samodzielny Publiczny Zaklad Opieki Zdrowotnej Zespól Szpitali Miejskich, Chorzów, Slaskie, Poland
Spitalul Clinic Judetean de Urgenta Tirgu-Mures, Targu-Mures, Mures, Romania
Institutul Regional de Oncologie Iasi, Iasi, , Romania
Sverdlovsk Regional Clinical Hospital #1, Ekaterinburg, , Russian Federation
Ryazan Regional Clinical Hospital, Ryazan, , Russian Federation
Saratov State Medical University, Saratov, , Russian Federation
Clinical Center of Serbia, Belgrade, , Serbia
Clinical Centre of Vojvodina, Novi Sad, , Serbia
Hospital Universitario Central de Asturias, Oviedo, Asturias, Spain
Hospital Universitari Germans Trias i Pujol, Badalona, Barcelona, Spain
Hospital Vall d´Hebrón, Barcelona, , Spain
Hospital San Pedro de Alcantara, Caceres, , Spain
Hospital General Virgen de las Nieves, Granada, , Spain
Hospital General Universitario Gregorio Marañon, Madrid, , Spain
Hospital Universitario 12 de Octubre, Madrid, , Spain
Hospital Clínico Universitario de Salamanca, Salamanca, , Spain
Hospital Universitario Virgen del Rocio, Sevilla, , Spain
Hospital Universitari i Politecnic La Fe de Valencia, Valencia, , Spain
Skånes Universitetssjukhus i Lund, Lund, Skane, Sweden
Karolinska University Hospital Huddinge, Stockholm, , Sweden
Chang Gung Medical Foundation-LinKou Branch, Tao-Yuan, Taoyuan, Taiwan
China Medical University Hospital, Taichung, , Taiwan
Mackay Memorial Hospital, Taipei, , Taiwan
National Taiwan University Hospital, Taipei, , Taiwan
Taipei Veterans General Hospital, Taipei, , Taiwan
Chelsea and Westminster Hospital NHS Foundation Trust, London, England, United Kingdom
King's College Hospital, London, England, United Kingdom
Medway Maritime Hospital, Gillingham, Kent, United Kingdom