488
Participants
Start Date
June 1, 2010
Primary Completion Date
January 22, 2014
Study Completion Date
July 25, 2016
Azacitidine
75 mg/m\^2 subcutaneous (SC) daily for 7 days for 28 day cycles until disease progression or unacceptable toxicity
Conventional Care Regimen
"Physician pre-selects prior to randomization from one of the following:~* Intensive chemotherapy (cytarabine 100-200 mg/m\^2 continuous intravenous infusion for 7 days + anthracycline IV x 3 days) + Best Supportive Care; induction with up to 2 consolidation cycles~* Low-dose cytarabine 20 mg subcutaneous (SC) twice a day (BID) for 10 days, for 28 day cycles + BSC; until disease progression or unacceptable toxicity~* Best Supportive Care only; until study end"
Wilhelminenspital, I Medizinische Abt., Vienna
Prince of Wales Hospital, Randwick
Peter MacCallum Cancer Centre, East Melbourne
Western Hospital, Footscray
Royal Melbourne Hospital, Melbourne
St Vincent's Hospital, Fitzroy
Klinikum Wels-Grieskirchen GmbH, Wels
Royal Adelaide Hospital, Adelaide
Landeskliniken Salzburg Saint Johanns-Spital, III Medizinische Abteilung, Salzburg
Cliniques Universitaires UCL de Mont-Godinne, Yvoir
Grand Hôpital de Charleroi, Charleroi
Centre Hospitalier de Jolimont-Lobbes, La Louvière
Algemeen Ziekenhuis Sint-Jan, Bruges
Universitair Ziekenhuis Gent, Ghent
National Taiwan University Hospital, Taipei
"Azienda Sanitaria Ospedaliera San Luigi Gonzaga", Orbassano
Taipei Veterans General Hospital Pei-Tou District, Taipei
Hôpital de la Conception, Marseille
Azienda Ospedaliera SS. Antonio E. Biagio E. Cesare Arrigo di Alessandria, Alessandria
University of Rostock, Div. of Haematology and Oncology, Rostock
Ospedale di Circolo e Fondazione Macchi, Varese
Hospital General Universitario Gregorio Marañon, Madrid
Centre Hospitalier Universitaire de Toulouse, Toulouse
Hospital Central de Asturias, Oviedo
Azienda Ospedaliero Universitaria S. Maria della Misericordia di Udine, Udine
Hospital Universitario de Salamanca, Salamanca
Azienda Ospedaliera Sant'Orsola Malpighi, Bologna
Heinrich-Heine-Universität Düsseldorf, Düesseldorf
Hospital Universitario Virgen del Rocío, Seville
Centre Hospitalier Universitaire Nantes, Hotel Dieu, Nantes
Universitatsklinikum Essen, Zentrum fur Tumorforschung und Tumortherapie, Essen
Hospital Universitario La Fe, Valencia
Rabin Medical Center, Petah Tikva
CHRU d'Angers, Angers
Azienda Ospedaliero-Universitaria Careggi, Florence
Chaim Sheba Medical Center - Tel Hashomer, Heart Institute, Tel Litwinsky
Azienda Ospedaliera Universitaria - Ospedali Riuniti di Ancona, Ancona
Centre Hospitalier de la Cote Basque, Aquitaine
Sourasky Medical Center, Tel Aviv
Centre Hospitalier Régional Universitaire, Hôpital de Hautepierre, Strasbourg
Universitatsklinikum Heidelberg, Heidelberg
Centre Hospitalier Universitaire de Lyon-Hôpital Edouard Herriot, Lyon
Azienda Ospedaliera Policlinico di Bari, Bari
Assaf Harofeh Medical Centre, Beer Yaakov
Hôpital Saint Louis, Paris
MD Anderson Cancer Center, Houston
Centre Hospitalier Universitaire d'Amiens, Groupe Hospitalier Sud, Amiens
Chang Gung Memorial Hospital, Kaohsiung, Niao-Sung Hsiang
Soroka Medical Center, Beersheba
IRCCS Centro di Riferimento Oncologico di Basilicata di Rionero in Vulture, Rionero in Vulture
Centre Hopitalier Universitaire Dupuytren, Limoges
Universitätsklinikum Ulm, Ulm
Azienda Ospedaliera Bianchi-Melacrino-Morelli, Reggio Calabria
Shaare Zedek Medical Center, Jerusalem
Hadassah Medical Center, Jerusalem
Hopital Percy Clamart, Clamart
Hospital Avicenne, Service d'hematologie Clinique, Bobigny
The Third Hospital of Peking University, Beijing
Peking Union Medical College Hospital, Beijing
City Clinical Hospital n.a. S. P. Botkin, Moscow
Saint Petersburg State Academician I.P. Pavlov Medical University, Saint Petersburg
Shanghai Ruijin Hospital, Shanghai
Shanghai Changhai Hospital,the Second Military Medical University, Shanghai
Peoples Hospital of Jiangsu Province, Jiangsu
"State Healthcare Institution Nizhny Novgorod N.A. Semashko Regional Clinical Hospital", Nizhny Novgorod
West China Hospital,Sichuan University, Sichuan
Central City Hospital # 7, Yekaterinburg
Tianjin Blood Disease Hospital, Tianjin
Massachusetts General Hospital, Boston
University of Alberta Hospital, Edmonton
Cancer Care Manitoba, Winnipeg
Queen Elizabeth II Health Sciences Centre, Halifax
Ottawa Hospital General Campus, Ottawa
Sunnybrook Odette Cancer Centre, Toronto
Hopital Maisonneuve-Rosemont, Montreal
Centre Hospitalier de l'Université de Montréal pavilion Notre Dame, Montreal
Hopital du Sacre Coeur de Montréal, Montreal
Tom Baker Cancer Centre, Calgary
Princess Margaret Hospital, Ontario
Fakultni nemocnice Brno, Brno
Fakultni nemocnice Olomouc, hemato-onkologicka klinika, Olomouc
Vseobecna Fakultni Nemocnice v Praze, Prague
Ustav hematologie a krevni transfuze, Prague
Centre Hospitalier Universitaire de Nice, Nice
Universitätsklinikum Leipzig, Leipzig
Universitätsklinikum Jena, Jena
Azienda Policlinico Umberto I di Roma, Roma
Policlinico Universitario Agostino Gemelli, Roma
Universitair Medisch Centrum Groningen, Groningen
Katedra i Klinika Hematologii, Nowotworów Krwi i Transplantacji Szpiku, Wroclaw
Dolnoslaskie Centrum Transplantacji Komórkowych z Krajowym Bankiem Dawców Szpiku, Wroclaw
Instytut Hematologii i Transfuzjologii, Warsaw
Samodzielny Publiczny SK im. A. Mieleckiego Slaskiego Uniwersytetu Medycznego w Katowicach, Katowice
Wojewodzki Szpital Specjalistczny im. Mikolaja Kopernika, Lódz
Saratov State Medical University, Saratov
Samsung Medical Center, Gangnam-gu
Seoul National University Hospital, Jongno-gu
Yonsei University Health System, Seodaemun-gu
Kyungpook National University Hospital, Daegu
Seoul Saint Mary's Hospital Seocho-gu, Seoul
Asan Medical Center, Seoul
Korea University Hospital at Guro, Seoul
Hospital Son Dureta, Palma de Mallorca
Hospital Son Llàtzer, Palma de Mallorca
Hospital Clinic i Provincial de Barcelona, Barcelona
Royal Marsden Hospital, Sutton
Royal Bournemouth Hospital, Bournemouth
Barts and the London NHS Trust, London
King's College Hospital, London
Manchester Royal Infirmary, Manchester
Churchill Hospital, Oxford
New Cross Hospital, Wolverhampton
Lead Sponsor
Celgene
INDUSTRY