Spots Global Cancer Trial Database for The Efficacy and Safety of Oral Azacitidine Plus Best Supportive Care Versus Placebo and Best Supportive Care in Subjects With Red Blood Cell (RBC) Transfusion-Dependent Anemia and Thrombocytopenia Due to International Prognostic Scoring System (IPSS) Low Risk Myelodysplastic Syndrome (MDS)
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Trial Identification
Brief Title: The Efficacy and Safety of Oral Azacitidine Plus Best Supportive Care Versus Placebo and Best Supportive Care in Subjects With Red Blood Cell (RBC) Transfusion-Dependent Anemia and Thrombocytopenia Due to International Prognostic Scoring System (IPSS) Low Risk Myelodysplastic Syndrome (MDS)
Official Title: A Phase 3, Multicenter, Randomized, Double-blind Study to Compare the Efficacy and Safety of Oral Azacitidine Plus Best Supportive Care Versus Placebo Plus Best Supportive Care in Subjects With Red Blood Cell Transfusion-dependent Anemia and Thrombocytopenia Due to IPSS Lower-risk Myelodysplastic Syndromes.
Study ID: NCT01566695
Conditions
Study Description
Brief Summary: Evaluation of the Efficacy and Safety of Oral Azacitidine plus Best Supportive care versus Placebo and Best Supportive care in subjects with red blood cell (RBC) transfusion-dependent anemia and thrombocytopenia due to International Prognostic Scoring System (IPSS) lower risk myelodysplastic syndromes (MDS).
Detailed Description:
Keywords
Eligibility
Minimum Age: 18 Years
Eligible Ages: ADULT, OLDER_ADULT
Sex: ALL
Healthy Volunteers: No
Locations
Alta Bates Comprehensive Cancer Center, Berkeley, California, United States
Tower Hematology/Oncology Medical Group and Tower Cancer Research Found, Beverly Hills, California, United States
City Of Hope, Duarte, California, United States
California Cancer Associates for Research and Excellence cCARE, Escondido, California, United States
Marin Oncology Associates, Greenbrae, California, United States
UCSD-Thornton Hospital, La Jolla, California, United States
University of Southern California Norris Cancer Center, Los Angeles, California, United States
Yale Cancer Center, New Haven, Connecticut, United States
University of Florida Health Cancer Center at Orlando Health, Orlando, Florida, United States
Phoebe Cancer Center of Phoebe Putney Memorial Hospital, Albany, Georgia, United States
Robert H Lurie Comprehensive Cancer Center NW Univ, Chicago, Illinois, United States
University Of Illinois At Chicago, Chicago, Illinois, United States
University Of Chicago Medical Center, Chicago, Illinois, United States
Loyola University Chicago, Maywood, Illinois, United States
University Of Kansas Medical Center, Kansas City, Kansas, United States
University of Louisville, J.G. Brown Cancer Center, Louisville, Kentucky, United States
Hematology And Oncology Specialists, Llc, Metairie, Louisiana, United States
Johns Hopkins Medicine, Baltimore, Maryland, United States
UMASS Memorial Hospital, Worcester, Massachusetts, United States
Mayo Clinic, Rochester, Minnesota, United States
Jackson Oncology Associates PLLC, Jackson, Mississippi, United States
Saint Luke's Cancer Institute, Kansas City, Missouri, United States
Kansas City VA Medical Center University of Kansas Medical Center, Kansas City, Missouri, United States
University Of Nebraska Medical Center, Omaha, Nebraska, United States
Weill Cornell Medical College - New York - Presbyterian Hospital, New York, New York, United States
Icahn School of Medicine at Mount Sinai Medical Center, New York, New York, United States
Levine Cancer Institute, Charlotte, North Carolina, United States
Eastern Institute of Medical Sciences, Greenville, North Carolina, United States
University Hospitals of Cleveland Case Medical Center, Cleveland, Ohio, United States
Ohio State University Medical Center, Columbus, Ohio, United States
Kaiser Permanente Northwest Oncology Hematology, Portland, Oregon, United States
Penn Medicine: University of Pennsylvania Health System, Philadelphia, Pennsylvania, United States
Western Pennsylvania Cancer Institute, Pittsburgh, Pennsylvania, United States
Brooke Army Medical Center Francis Street Medical Center, Fort Sam Houston, Texas, United States
Local Institution - 900, Houston, Texas, United States
Michael Debakey VA Medical Center, Houston, Texas, United States
Millennium Physicians - Oncology, Houston, Texas, United States
VA Commonwealth University - Massey Cancer Center, Richmond, Virginia, United States
Fred Hutchinson Cancer Center, Seattle, Washington, United States
Waukesha Memorial Hospital, Waukesha, Wisconsin, United States
Local Institution - 137, Garran, Australian Capital Territory, Australia
Local Institution - 129, Adelaide, South Australia, Australia
Local Institution - 134, Clayton, Victoria, Australia
Local Institution - 132, Frankston, Victoria, Australia
Local Institution - 131, Camperdown, , Australia
Local Institution - 127, Epping, VIC, , Australia
Local Institution - 133, Fitzroy, , Australia
Local Institution - 135, Kogarah, , Australia
Local Institution - 130, Malvern, , Australia
Local Institution - 126, Milton, Brisbane, , Australia
Local Institution - 138, Waratah, , Australia
Local Institution - 136, Woolloongabba, , Australia
Local Institution - 203, Brasschaat, , Belgium
Local Institution - 200, Brugge, , Belgium
Local Institution - 202, Charleroi, , Belgium
Local Institution - 201, Leuven, , Belgium
Local Institution - 154, Fortaleza, Ceará, Brazil
Local Institution - 155, Curitiba, Paraná, Brazil
Local Institution - 152, Porto Alegre, Rio Grande Do Sul, Brazil
Local Institution - 153, Rio De Janeiro, , Brazil
Local Institution - 151, Sao Paulo, , Brazil
Local Institution - 182, Edmonton, Alberta, Canada
Local Institution - 178, Vancouver, British Columbia, Canada
Local Institution - 183, Barrie, Ontario, Canada
Local Institution - 180, Hamilton, Ontario, Canada
Local Institution - 179, Toronto, Ontario, Canada
Local Institution - 176, Toronto, Ontario, Canada
Local Institution - 181, Montreal, Quebec, Canada
Local Institution - 177, Montreal, Quebec, Canada
Local Institution - 226, Brno, Jihomoravský Kraj, Czechia
Local Institution - 230, Hradec Králové, , Czechia
Local Institution - 229, Olomouc, , Czechia
Local Institution - 228, Praha, , Czechia
Local Institution - 227, Praha, , Czechia
Local Institution - 253, Aarhus, , Denmark
Local Institution - 252, Odense C, , Denmark
Local Institution - 251, Roskilde, , Denmark
Local Institution - 276, Helsinki, , Finland
Local Institution - 277, Turku, , Finland
Local Institution - 305, Lille, , France
Local Institution - 304, Marseille Cedex 9, , France
Local Institution - 301, Nantes, , France
Local Institution - 308, Paris, , France
Local Institution - 307, Pierre-Bénite Cedex, , France
Local Institution - 302, Rennes Cedex, , France
Local Institution - 303, Rouen Cedex, , France
Local Institution - 306, Strasbourg, , France
Local Institution - 300, Toulouse Cedex 9, , France
Local Institution - 309, Tours, , France
Local Institution - 350, Dresden, , Germany
Local Institution - 361, Dresden, , Germany
Local Institution - 359, Duesseldorf, , Germany
Local Institution - 355, Dusseldorf, , Germany
Local Institution - 356, Hamburg, , Germany
Local Institution - 353, Keil, , Germany
Local Institution - 351, Leipzig, , Germany
Local Institution - 352, München, , Germany
Local Institution - 357, Tubingen, , Germany
Local Institution - 360, Ulm, , Germany
Local Institution - 853, Heraklion, Irakleio, Greece
Local Institution - 851, Alexandroupolis, , Greece
Local Institution - 852, Athens, , Greece
Local Institution - 855, Athens, , Greece
Local Institution - 850, Athens, , Greece
Local Institution - 854, Patras, , Greece
Local Institution - 452, Tel-Aviv, Tel Aviv, Israel
Local Institution - 453, Haifa, , Israel
Local Institution - 451, Petach Tikva, , Israel
Local Institution - 454, Tel Hashomer, , Israel
Local Institution - 482, Alessandria, , Italy
Local Institution - 492, Bari, , Italy
Local Institution - 489, Bologna, , Italy
Local Institution - 494, Cagliari, , Italy
Local Institution - 486, Firenze, , Italy
Local Institution - 479, Lecce, , Italy
Local Institution - 488, Milano, , Italy
Local Institution - 498, Milan, , Italy
Local Institution - 497, Novara, , Italy
Local Institution - 480, Palermo, , Italy
Local Institution - 495, Pavia, , Italy
Local Institution - 496, Pisa, , Italy
Local Institution - 485, Reggio Calabria, , Italy
Local Institution - 484, Rionero in Vulture, , Italy
Local Institution - 487, Roma, , Italy
Local Institution - 490, Roma, , Italy
Local Institution - 481, Roma, , Italy
Local Institution - 499, Terni, , Italy
Local Institution - 477, Torino, , Italy
Local Institution - 493, Torrette Di Ancona, , Italy
Local Institution - 478, Udine, , Italy
Local Institution - 476, Venezia - Mestre, , Italy
Local Institution - 704, Busan, , Korea, Republic of
Local Institution - 703, Daegu, , Korea, Republic of
Local Institution - 701, Seoul, , Korea, Republic of
Local Institution - 702, Seoul, , Korea, Republic of
Local Institution - 700, Seoul, , Korea, Republic of
Local Institution - 830, Huixquilucan de Degollado, , Mexico
Local Institution - 828, Monterrey, , Mexico
Local Institution - 829, Monterrey, , Mexico
Local Institution - 827, Tlalpan, , Mexico
Local Institution - 528, Amsterdam, , Netherlands
Local Institution - 527, Groningen, , Netherlands
Local Institution - 526, Nijmegen, , Netherlands
Local Institution - 529, Rotterdam, , Netherlands
Local Institution - 552, Førde, , Norway
Local Institution - 551, Oslo, , Norway
Local Institution - 582, Bydgoszcz, , Poland
Local Institution - 576, Gdansk, , Poland
Local Institution - 579, Krakow, , Poland
Local Institution - 581, Lodz, , Poland
Local Institution - 580, Torun, , Poland
Local Institution - 583, Warszawa, , Poland
Local Institution - 577, Warszawa, , Poland
Local Institution - 578, Wroclaw, , Poland
Local Institution - 604, Beja, , Portugal
Local Institution - 600, Coimbra, , Portugal
Local Institution - 601, Lisboa, , Portugal
Local Institution - 603, Lisboa, , Portugal
Local Institution - 602, Porto, , Portugal
Local Institution - 626, Badalona (Barcelona), , Spain
Local Institution - 635, Barcelona, , Spain
Local Institution - 625, Barcelona, , Spain
Local Institution - 636, Granada, , Spain
Local Institution - 629, Madrid, , Spain
Local Institution - 634, Madrid, , Spain
Local Institution - 631, Madrid, , Spain
Local Institution - 632, Malaga, , Spain
Local Institution - 628, Oviedo, , Spain
Local Institution - 630, Salamanca, , Spain
Local Institution - 627, Seville, , Spain
Local Institution - 633, Vitoria-Gasteiz, Álava, , Spain
Local Institution - 653, Goeteborg, , Sweden
Local Institution - 652, Lund, , Sweden
Local Institution - 651, Stockholm, , Sweden
Local Institution - 401, Adana, , Turkey
Local Institution - 405, Antalya, , Turkey
Local Institution - 403, Istanbul, , Turkey
Local Institution - 400, Istanbul, , Turkey
Local Institution - 404, Mersin, , Turkey
Local Institution - 402, Trabzon, , Turkey
Local Institution - 685, Oxford, Oxfordshire, United Kingdom
Local Institution - 687, Aberdeen, , United Kingdom
Local Institution - 691, Birmingham, , United Kingdom
Local Institution - 686, Bristol, , United Kingdom
Local Institution - 689, Cambridge, , United Kingdom
Local Institution - 678, Cardiff, , United Kingdom
Local Institution - 688, Harrow Middlesex, , United Kingdom
Local Institution - 692, Hull, , United Kingdom
Local Institution - 677, Leicester, , United Kingdom
Local Institution - 683, Liverpool, , United Kingdom
Local Institution - 676, London, , United Kingdom
Local Institution - 684, London, , United Kingdom
Local Institution - 679, Manchester, , United Kingdom
Local Institution - 681, Nottingham, , United Kingdom
Local Institution - 690, Sutton in Ashfield, , United Kingdom
Local Institution - 680, Wolverhampton, , United Kingdom
Contact Details
Name: Bristol-Myers Squibb
Affiliation: Bristol-Myers Squibb
Role: STUDY_DIRECTOR
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