216
Participants
Start Date
April 26, 2013
Primary Completion Date
January 25, 2019
Study Completion Date
December 21, 2023
Oral Azacitidine
300 mg daily, days 1 to 21 of each 28-day treatment cycle
Placebo
Identically matching placebo tablets on day 1 to 21 of each 28-day treatment cycle.
Best Supportiv Care (BSC)
BSC included and was not limited to packed RBC (packed red blood cell \[pRBC\] and whole blood), platelet transfusions (single donor or pooled donor), antibiotic, antiviral and/or antifungal therapy, nutritional support, and granulocyte colony stimulating factors (G-CSF) for participants who experienced neutropenic fever/infections.
Local Institution - 633, Vitoria-Gasteiz, Álava
Local Institution - 131, Camperdown
Local Institution - 135, Kogarah
Local Institution - 137, Garran
Local Institution - 203, Brasschaat
Local Institution - 201, Leuven
Local Institution - 133, Fitzroy
Local Institution - 127, Epping, VIC
Local Institution - 130, Malvern
Local Institution - 134, Clayton
Local Institution - 132, Frankston
Local Institution - 126, Milton, Brisbane
Local Institution - 252, Odense C
Local Institution - 202, Charleroi
Local Institution - 552, Førde
Local Institution - 308, Paris
Local Institution - 200, Bruges
Local Institution - 253, Aarhus
Local Institution - 625, Barcelona
Local Institution - 626, Badalona (Barcelona)
Weill Cornell Medical College - New York - Presbyterian Hospital, New York
Icahn School of Medicine at Mount Sinai Medical Center, New York
Local Institution - 477, Torino
Local Institution - 852, Athens
Local Institution - 304, Marseille
Local Institution - 827, Tlalpan
Local Institution - 651, Stockholm
Local Institution - 482, Alessandria
Western Pennsylvania Cancer Institute, Pittsburgh
Local Institution - 636, Granada
Penn Medicine: University of Pennsylvania Health System, Philadelphia
Local Institution - 498, Milan
Local Institution - 488, Milan
Local Institution - 277, Turku
Johns Hopkins Medicine, Baltimore
Local Institution - 353, Keil
Local Institution - 854, Pátrai
Local Institution - 495, Pavia
Eastern Institute of Medical Sciences, Greenville
Local Institution - 629, Madrid
Local Institution - 634, Madrid
Local Institution - 631, Madrid
Local Institution - 497, Novara
Levine Cancer Institute, Charlotte
Local Institution - 632, Málaga
Local Institution - 476, Venezia - Mestre
Local Institution - 300, Toulouse
Local Institution - 453, Haifa
Phoebe Cancer Center of Phoebe Putney Memorial Hospital, Albany
University of Florida Health Cancer Center at Orlando Health, Orlando
Local Institution - 628, Oviedo
Local Institution - 478, Udine
Local Institution - 404, Mersin
Local Institution - 403, Istanbul
Local Institution - 400, Istanbul
Local Institution - 302, Rennes
Local Institution - 630, Salamanca
Local Institution - 309, Tours
Jackson Oncology Associates PLLC, Jackson
Local Institution - 489, Bologna
University of Louisville, J.G. Brown Cancer Center, Louisville
Local Institution - 355, Düsseldorf
Local Institution - 359, Düsseldorf
Local Institution - 627, Seville
Ohio State University Medical Center, Columbus
Local Institution - 301, Nantes
Local Institution - 451, Petah Tikva
Local Institution - 486, Florence
Local Institution - 454, Tel Litwinsky
Local Institution - 830, Huixquilucan de Degollado
Mayo Clinic, Rochester
Local Institution - 496, Pisa
Local Institution - 305, Lille
Local Institution - 493, Torrette Di Ancona
Loyola University Chicago, Maywood
Robert H Lurie Comprehensive Cancer Center NW Univ, Chicago
University Of Illinois At Chicago, Chicago
University Of Chicago Medical Center, Chicago
Local Institution - 402, Trabzon
Saint Luke's Cancer Institute, Kansas City
Kansas City VA Medical Center University of Kansas Medical Center, Kansas City
Local Institution - 452, Tel Aviv
Local Institution - 828, Monterrey
Local Institution - 829, Monterrey
Local Institution - 306, Strasbourg
Local Institution - 851, Alexandroupoli
Local Institution - 307, Pierre-Bénite
Hematology And Oncology Specialists, Llc, Metairie
Local Institution - 492, Bari
Local Institution - 853, Heraklion
Local Institution - 357, Tübingen
Local Institution - 479, Lecce
Local Institution - 303, Rouen
Local Institution - 900, Houston
Local Institution - 924, Houston
Millennium Physicians - Oncology, Houston
Local Institution - 229, Olomouc
Local Institution - 352, München
Local Institution - 484, Rionero in Vulture
Local Institution - 360, Ulm
Local Institution - 485, Reggio Calabria
University of Southern California Norris Cancer Center, Los Angeles
Local Institution - 480, Palermo
Tower Hematology/Oncology Medical Group and Tower Cancer Research Found, Beverly Hills
California Cancer Associates for Research and Excellence cCARE, Escondido
Alta Bates Comprehensive Cancer Center, Berkeley
Local Institution - 917, Portland
Local Institution - 154, Fortaleza
City Of Hope, Duarte
Marin Oncology Associates, Greenbrae
UCSD-Thornton Hospital, La Jolla
Local Institution - 942, New Haven
University Of Kansas Medical Center, Kansas City
UMASS Memorial Hospital, Worcester
University Of Nebraska Medical Center, Omaha
University Hospitals of Cleveland Case Medical Center, Cleveland
Brooke Army Medical Center Francis Street Medical Center, Fort Sam Houston
VA Commonwealth University - Massey Cancer Center, Richmond
Local Institution - 904, Seattle
Waukesha Memorial Hospital, Waukesha
Local Institution - 129, Adelaide
Local Institution - 138, Waratah
Local Institution - 136, Woolloongabba
Local Institution - 155, Curitiba
Local Institution - 152, Porto Alegre
Local Institution - 153, Rio de Janeiro
Local Institution - 151, São Paulo
Local Institution - 182, Edmonton
Local Institution - 178, Vancouver
Local Institution - 183, Barrie
Local Institution - 180, Hamilton
Local Institution - 179, Toronto
Local Institution - 176, Toronto
Local Institution - 181, Montreal
Local Institution - 177, Montreal
Local Institution - 226, Brno
Local Institution - 230, Hradec Králové
Local Institution - 228, Prague
Local Institution - 227, Prague
Local Institution - 251, Roskilde
Local Institution - 276, Helsinki
Local Institution - 350, Dresden
Local Institution - 361, Dresden
Local Institution - 356, Hamburg
Local Institution - 351, Leipzig
Local Institution - 855, Athens
Local Institution - 850, Athens
Local Institution - 494, Cagliari
Local Institution - 487, Roma
Local Institution - 490, Roma
Local Institution - 481, Roma
Local Institution - 499, Terni
Local Institution - 528, Amsterdam
Local Institution - 527, Groningen
Local Institution - 526, Nijmegen
Local Institution - 529, Rotterdam
Local Institution - 551, Oslo
Local Institution - 582, Bydgoszcz
Local Institution - 576, Gdansk
Local Institution - 579, Krakow
Local Institution - 581, Lodz
Local Institution - 580, Torun
Local Institution - 583, Warsaw
Local Institution - 577, Warsaw
Local Institution - 578, Wroclaw
Local Institution - 604, Beja
Local Institution - 600, Coimbra
Local Institution - 601, Lisbon
Local Institution - 603, Lisbon
Local Institution - 602, Porto
Local Institution - 704, Busan
Local Institution - 703, Daegu
Local Institution - 701, Seoul
Local Institution - 702, Seoul
Local Institution - 700, Seoul
Local Institution - 635, Barcelona
Local Institution - 653, Gothenburg
Local Institution - 652, Lund
Local Institution - 401, Adana
Local Institution - 405, Antalya
Local Institution - 685, Oxford
Local Institution - 687, Aberdeen
Local Institution - 691, Birmingham
Local Institution - 686, Bristol
Local Institution - 689, Cambridge
Local Institution - 678, Cardiff
Local Institution - 688, Harrow Middlesex
Local Institution - 692, Hull
Local Institution - 677, Leicester
Local Institution - 683, Liverpool
Local Institution - 676, London
Local Institution - 684, London
Local Institution - 679, Manchester
Local Institution - 681, Nottingham
Local Institution - 690, Sutton in Ashfield
Local Institution - 680, Wolverhampton
Lead Sponsor
Celgene
INDUSTRY