319
Participants
Start Date
December 30, 2015
Primary Completion Date
March 17, 2020
Study Completion Date
March 25, 2024
AG-221
Continuous 28-day cycles of AG 221 100 mg orally (PO) once a day (QD) for 28 days
BSC
Best supportive care includes, hydroxyurea for leukocytosis and/or differentiation-like syndrome, anti-infectives, analgesics, antiemetics, antipyretics, transfusions and nutritional support
Azacitidine
continuous 28-day cycles of azacitidine 75 mg/m2/day SC for 7 days, plus BSC
Low-dose cytarabine (LDAC)
continuous 28-day cycles of cytarabine 20 mg SC twice a day (BID) for 10 days, plus BSC
Intermediate-dose cytarabine (IDAC)
28-day cycles of cytarabine 0.5 to 1.5 g/m2/day IV for 3 to 6 days, per standard institutional practice, plus BSC; only BSC given after IDAC therapy concludes per standard institutional practice
Local Institution - 889, Zhengzhou
Local Institution - 941, Taoyuan District
Local Institution - 942, Taichung, Northern Dist.
Local Institution - 831, Copenhagen
Local Institution - 901, Concord
Local Institution - 906, East Melbourne
Local Institution - 905, Melbourne
Local Institution - 803, Linz
Local Institution - 904, Adelaide
Local Institution - 811, Yvoir
Local Institution - 871, Ankara
Local Institution - 704, Barcelona
Local Institution - 940, Taipei, Zhongzheng Dist.
Local Institution - 128, New York
Montefiore Medical Center Albert Einstein Cancer Center, The Bronx
Local Institution - 612, Marseille
Roswell Park Cancer Institute, Buffalo
Strong Health System, Rochester
Local Institution - 874, Denizli
Local Institution - 304, Brescia
Local Institution - 875, Gaziantep
Duke University Medical Center, Durham
Local Institution - 104, Greenville
Local Institution - 401, Hanover
Local Institution - 609, Toulouse
University of Florida Health Cancer Center at Orlando Health, Orlando
Local Institution - 701, Oviedo
Local Institution - 121, Miami
Local Institution - 607, Pessac
Local Institution - 709, Salamanca
Local Institution - 305, Bologna
Local Institution - 702, Seville
Local Institution - 601, Nantes
University Hospitals Cleveland Medical Center, Cleveland
Local Institution - 413, Essen
Local Institution - 706, Avda, Campanar 21
Local Institution - 606, Angers
Local Institution - 302, Florence
Local Institution - 402, Mainz
Local Institution - 602, Lille
Local Institution - 406, Frankfurt
Local Institution - 111, Chicago
Local Institution - 611, Pierre-Bénite
Baylor Sammons Cancer Center, Dallas
Local Institution - 610, Versailles
Local Institution - 301, Naples
Local Institution - 409, München
Local Institution - 407, Ulm
Local Institution - 303, Reggio Calabria
Local Institution - 306, Palermo
Local Institution - 605, Bobigny
Local Institution - 604, Villejuif
Local Institution - 885, Beijing
Local Institution - 884, Beijing
Local Institution - 892, Beijing
Local Institution - 864, Moscow
Local Institution - 863, Moscow
Local Institution - 862, Saint Petersburg
Local Institution - 887, Shanghai
Local Institution - 891, Shanghai
Local Institution - 883, Hangzhou
Local Institution - 882, Fuzhou
Local Institution - 881, Guangzhou, Guangdong
Local Institution - 888, Chengdu, Sichuan
Local Institution - 861, Krasnoyarsk
John Theurer Cancer Center at Hackensack University Medical Center, Hackensack
Local Institution - 250, Porto Alegre
Local Institution - 252, Porto Alegre, RS
Local Institution - 251, Jaú
Local Institution - 253, Rio de Janeiro
Local Institution - 254, São Paulo
Local Institution - 202, Edmonton
Local Institution - 203, Winnipeg
Local Institution - 201, Toronto
Local Institution - 204, Montreal
Local Institution - 822, Prague
Local Institution - 834, Aalborg
Local Institution - 833, Arhus C
Local Institution - 832, Odense
Local Institution - 403, Dresden
Local Institution - 412, Leipzig
Local Institution - 307, Roma
Local Institution - 953, Hwasun-gun
Local Institution - 952, Seoul
Local Institution - 708, Barcelona
Local Institution - 873, Ankara
Local Institution - 872, Ankara
Local Institution - 503, Nottingham
Local Institution - 501, London
Local Institution - 507, London
Local Institution - 502, Manchester Withington
Local Institution - 510, Oxford
Local Institution - 509, Sutton (Surrey)
Lead Sponsor
Celgene
INDUSTRY