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Brief Title: Study of Vidaza Versus Conventional Care Regimens for the Treatment of Acute Myeloid Leukemia (AML)
Official Title: A Phase 3, Multicenter, Randomized, Open-Label, Study of Azacitidine (Vidaza®) Versus Conventional Care Regimens for the Treatment of Older Subjects With Newly Diagnosed Acute Myeloid Leukemia
Study ID: NCT01074047
Brief Summary: The purpose of this study is to compare the effect of azacitidine (Vidaza) to conventional care regimens on overall survival in elderly AML patients.
Detailed Description:
Minimum Age: 65 Years
Eligible Ages: OLDER_ADULT
Sex: ALL
Healthy Volunteers: No
Massachusetts General Hospital, Boston, Massachusetts, United States
MD Anderson Cancer Center, Houston, Texas, United States
Prince of Wales Hospital, Randwick, New South Wales, Australia
Royal Adelaide Hospital, Adelaide, South Australia, Australia
Peter MacCallum Cancer Centre, East Melbourne, Victoria, Australia
Western Hospital, Footscray, Victoria, Australia
Royal Melbourne Hospital, Melbourne, Victoria, Australia
St Vincent's Hospital, Fitzroy, , Australia
Klinikum Wels-Grieskirchen GmbH, Wels, Upper Austria, Austria
Wilhelminenspital, I Medizinische Abt., Wien, Vienna, Austria
Landeskliniken Salzburg Saint Johanns-Spital, III Medizinische Abteilung, Salzburg, , Austria
Grand Hôpital de Charleroi, Charleroi, Hainaut, Belgium
Cliniques Universitaires UCL de Mont-Godinne, Yvoir, Namur, Belgium
Universitair Ziekenhuis Gent, Ghent, Oost-vlaanderen, Belgium
Algemeen Ziekenhuis Sint-Jan, Brugge, West-vlaanderen, Belgium
Centre Hospitalier de Jolimont-Lobbes, La Louvière, , Belgium
University of Alberta Hospital, Edmonton, Alberta, Canada
Cancer Care Manitoba, Winnipeg, Manitoba, Canada
Queen Elizabeth II Health Sciences Centre, Halifax, Nova Scotia, Canada
Ottawa Hospital General Campus, Ottawa, Ontario, Canada
Sunnybrook Odette Cancer Centre, Toronto, Ontario, Canada
Hopital Maisonneuve-Rosemont, Montreal, Quebec, Canada
Centre Hospitalier de l'Université de Montréal pavilion Notre Dame, Montreal, Quebec, Canada
Hopital du Sacre Coeur de Montréal, Montreal, Quebec, Canada
Tom Baker Cancer Centre, Calgary, , Canada
Princess Margaret Hospital, Ontario, , Canada
The Third Hospital of Peking University, Beijing, , China
Peking Union Medical College Hospital, Beijing, , China
Peoples Hospital of Jiangsu Province, Jiangsu, , China
Shanghai Ruijin Hospital, Shanghai, , China
Shanghai Changhai Hospital,the Second Military Medical University, Shanghai, , China
West China Hospital,Sichuan University, Sichuan, , China
Tianjin Blood Disease Hospital, Tianjin, , China
Fakultni nemocnice Brno, Brno, Jihormoravsky Kraj, Czechia
Fakultni nemocnice Olomouc, hemato-onkologicka klinika, Olomouc, Olomoucký Kraj, Czechia
Vseobecna Fakultni Nemocnice v Praze, Praha 2, Praha, Czechia
Ustav hematologie a krevni transfuze, Praha 2, Praha, Czechia
Centre Hospitalier Régional Universitaire, Hôpital de Hautepierre, Strasbourg, Alsace, France
Hospital Avicenne, Service d'hematologie Clinique, Bobigny, ILE-DE-France, France
Hopital Percy Clamart, Clamart Cedex, Ile-de-france, France
Hôpital Saint Louis, Paris Cedex 10, Ile-de-france, France
Centre Hopitalier Universitaire Dupuytren, Limoges, Limousin Lorraine, France
Centre Hospitalier Universitaire de Toulouse, Toulouse Cedex 09, Midi-pyrénées, France
Centre Hospitalier Universitaire de Nice, Nice Cedex 3, Nice, France
CHRU d'Angers, Angers cedex 09, Pays de La Loire, France
Centre Hospitalier Universitaire Nantes, Hotel Dieu, Nantes Cedex 1, Pays de La Loire, France
Centre Hospitalier Universitaire d'Amiens, Groupe Hospitalier Sud, Amiens Cedex 1, Picardie, France
Hôpital de la Conception, Marseille, Provence Alpes Cote D'azur, France
Centre Hospitalier de la Cote Basque, Aquitaine, , France
Centre Hospitalier Universitaire de Lyon-Hôpital Edouard Herriot, Lyon Cedex 03, , France
Universitatsklinikum Heidelberg, Heidelberg, Baden-wuerttemberg, Germany
Universitätsklinikum Ulm, Ulm, Baden-wuerttemberg, Germany
University of Rostock, Div. of Haematology and Oncology, Rostock, Mecklenburg-vorpommern, Germany
Heinrich-Heine-Universität Düsseldorf, Düesseldorf, Nordrhein-westfalen, Germany
Universitatsklinikum Essen, Zentrum fur Tumorforschung und Tumortherapie, Essen, Nordrhein-Westfallen, Germany
Universitätsklinikum Leipzig, Leipzig, Sachsen, Germany
Universitätsklinikum Jena, Jena, Thueringen, Germany
Soroka Medical Center, Beer Sheva, Beersheva, Israel
Assaf Harofeh Medical Centre, Beer Yaakov, , Israel
Shaare Zedek Medical Center, Jerusalem, , Israel
Hadassah Medical Center, Jerusalem, , Israel
Rabin Medical Center, Petach Tikva, , Israel
Sourasky Medical Center, Tel Aviv, , Israel
Chaim Sheba Medical Center - Tel Hashomer, Heart Institute, Tel Hashomer, , Israel
IRCCS Centro di Riferimento Oncologico di Basilicata di Rionero in Vulture, Rionero in Vulture, Potenza, Italy
Azienda Sanitaria Ospedaliera "San Luigi Gonzaga", Orbassano, Turin, Italy
Azienda Ospedaliera SS. Antonio E. Biagio E. Cesare Arrigo di Alessandria, Alessandria, , Italy
Azienda Ospedaliera Universitaria - Ospedali Riuniti di Ancona, Ancona, , Italy
Azienda Ospedaliera Policlinico di Bari, Bari, , Italy
Azienda Ospedaliera Sant'Orsola Malpighi, Bologna, , Italy
Azienda Ospedaliero-Universitaria Careggi, Firenze, , Italy
Azienda Ospedaliera Bianchi-Melacrino-Morelli, Reggio Calabria, , Italy
Azienda Policlinico Umberto I di Roma, Roma, , Italy
Policlinico Universitario Agostino Gemelli, Roma, , Italy
Azienda Ospedaliero Universitaria S. Maria della Misericordia di Udine, Udine, , Italy
Ospedale di Circolo e Fondazione Macchi, Varese, , Italy
Samsung Medical Center, Gangnam-gu, Seoul, Korea, Republic of
Seoul National University Hospital, Jongno-gu, Seoul, Korea, Republic of
Yonsei University Health System, Seodaemun-gu, Seoul, Korea, Republic of
Kyungpook National University Hospital, Daegu, , Korea, Republic of
Seoul Saint Mary's Hospital Seocho-gu, Seoul, , Korea, Republic of
Asan Medical Center, Seoul, , Korea, Republic of
Korea University Hospital at Guro, Seoul, , Korea, Republic of
Universitair Medisch Centrum Groningen, Groningen, , Netherlands
Katedra i Klinika Hematologii, Nowotworów Krwi i Transplantacji Szpiku, Wroclaw, Dolnoslaskie, Poland
Dolnoslaskie Centrum Transplantacji Komórkowych z Krajowym Bankiem Dawców Szpiku, Wroclaw, Dolnoslaskie, Poland
Wojewodzki Szpital Specjalistczny im. Mikolaja Kopernika, Lódz, Lodzkie, Poland
Instytut Hematologii i Transfuzjologii, Warszawa, Mazowieckie, Poland
Samodzielny Publiczny SK im. A. Mieleckiego Slaskiego Uniwersytetu Medycznego w Katowicach, Katowice, Slaskie, Poland
Central City Hospital # 7, Ekaterinburg, , Russian Federation
City Clinical Hospital n.a. S. P. Botkin, Moscow, , Russian Federation
State Healthcare Institution "Nizhny Novgorod N.A. Semashko Regional Clinical Hospital", Nizhniy Novgorod, , Russian Federation
Saint Petersburg State Academician I.P. Pavlov Medical University, Saint Petersburg, , Russian Federation
Saratov State Medical University, Saratov, , Russian Federation
Hospital Central de Asturias, Oviedo, Asturias, Spain
Hospital Son Dureta, Palma de Mallorca, Baleares, Spain
Hospital Son Llàtzer, Palma de Mallorca, Baleares, Spain
Hospital Clinic i Provincial de Barcelona, Barcelona, , Spain
Hospital General Universitario Gregorio Marañon, Madrid, , Spain
Hospital Universitario de Salamanca, Salamanca, , Spain
Hospital Universitario Virgen del Rocío, Sevilla, , Spain
Hospital Universitario La Fe, Valencia, , Spain
Chang Gung Memorial Hospital, Kaohsiung, Niao-Sung Hsiang, Kaohsiung, Taiwan
National Taiwan University Hospital, Taipei, , Taiwan
Taipei Veterans General Hospital Pei-Tou District, Taipei, , Taiwan
Royal Marsden Hospital, Sutton, Surrey, United Kingdom
Royal Bournemouth Hospital, Bournemouth, , United Kingdom
Barts and the London NHS Trust, London, , United Kingdom
King's College Hospital, London, , United Kingdom
Manchester Royal Infirmary, Manchester, , United Kingdom
Churchill Hospital, Oxford, , United Kingdom
New Cross Hospital, Wolverhampton, , United Kingdom
Name: C L Beach, PharmD
Affiliation: Celgene Corporation
Role: STUDY_DIRECTOR