A Study to Compare the Efficacy and Safety of Oral Azacitidine Plus Best Supportive Care (BSC) Versus Placebo Plus BSC in Participants With International Prognostic Scoring System Revised (IPSS-R) Low- or Intermediate-risk Myelodysplastic Syndrome (MDS) Summary The purpose of this study is to evaluate the safety and efficacy of oral azacitidine in participants with low to intermediate International Prognostic Scoring System Revised (IPSS-R) myelodysplastic syndrome (MDS ).
View Eligibility Criteria Eligibility Criteria Inclusion Criteria: • Participant has a documented diagnosis of MDS according to WHO 2016 classification that meets International Prognostic Scoring System Revised (IPSS-R) classification of low- or intermediate-risk disease (IPSS-R score between 1.5 and 4.5). MDS diagnosis, WHO classification, and IPSS-R risk classification will be prospectively determined by independent central pathology and cytogenetics review, and applicable central laboratory results. • Participant must have an Eastern Cooperative Oncology Group (ECOG) performance status of 0, 1, or 2. Exclusion Criteria: Participants with prior malignancies must have an expected median life expectancy of at least 12 months at the time of inclusion and no active treatment of any sort for at least 24 weeks prior to randomization (including but not limited to immunotherapy or targeted therapy) Hypoplastic Myelodysplastic Syndrome (MDS) with a marrow cellularity of ≤ 10% Participants diagnosed with MDS with excess blasts-2 (MDS-EB2) Prior treatment with azacitidine (any formulation), decitabine, or other hypomethylating agent Other protocol-defined inclusion/exclusion criteria apply
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There are 117 Locations for this study
University of Miami Hospital and Clinics, Sylvester Cancer Center Miami Florida, 33136, United States
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Advanced Research Tamarac Florida, 33321, United States
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Moffitt Cancer Center Tampa Florida, 33612, United States
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Henry Ford Hospital Detroit Michigan, 48202, United States
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Rutgers Cancer Institute of New Jersey New Brunswick New Jersey, 08903, United States
Hematology-Oncology Associates of Central New York, PC East Syracuse New York, 13057, United States
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Memorial Sloan Kettering Cancer Center New York New York, 10065, United States
Novant Health Presbyterian Medical Center Charlotte North Carolina, 28204, United States
Oregon Health and Science University Portland Oregon, 97239, United States
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AHN West Penn Hospital Pittsburgh Pennsylvania, 15224, United States
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Charleston Oncology, P.A. Charleston South Carolina, 29414, United States
Houston Methodist Hospital Houston Texas, 77030, United States
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University of Texas MD Anderson Cancer Center Houston Texas, 77030, United States
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Huntsman Cancer Institute Salt Lake City Utah, 84112, United States
Inova Schar Cancer Institute Fairfax Virginia, 22031, United States
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Local Institution - 0070 Pilar Buenos Aires, 1629, Argentina
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Local Institution - 0039 ABB Ciudad Autónoma De Buenos Aires, C1199, Argentina
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Local Institution - 0021 Buenos Aires Ciudad Autónoma De Buenos Aires, C1118, Argentina
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Local Institution - 0016 Buenos Aires , 1425, Argentina
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Local Institution - 0022 Buenos Aires , 1431, Argentina
Local Institution - 0050 Buenos Aires , CP128, Argentina
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Local Institution - 0144 Darlinghurst New South Wales, 2010, Australia
Local Institution - 0145 Macquarie University New South Wales, 2109, Australia
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Local Institution - 0146 Nowra New South Wales, 2541, Australia
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Local Institution - 0006 Clayton Victoria, 3168, Australia
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Local Institution - 0069 Heidelberg Victoria, 3084, Australia
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Local Institution - 0018 Melbourne Victoria, 3000, Australia
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Local Institution - 0004 Melbourne Victoria, 3065, Australia
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Local Institution - 0003 Melbourne , 3004, Australia
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Local Institution - 0034 Linz Oberösterreich, 4020, Austria
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Local Institution - 0029 Vienna Wien, 1140, Austria
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Local Institution - 0074 Salzburg , 5020, Austria
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Local Institution - 0091 Calgary Alberta, T2N 4, Canada
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Local Institution - 0008 Toronto Ontario, M4N 3, Canada
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Local Institution - 0015 Toronto Ontario, M5G 2, Canada
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Local Institution - 0090 Montréal Quebec, H4A 3, Canada
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Local Institution - 0171 Beijing Beijing, 10003, China
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Local Institution - 0167 Guangzhou Guangdong, 51051, China
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Local Institution - 0156 Wuhan Hubei, 43003, China
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Local Institution - 0157 Wuhan Hubei, 43005, China
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Local Institution - 0168 Changsha Hunan, 41000, China
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Local Institution - 0162 Nanjing Jiangsu, 21002, China
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Local Institution - 0163 Suzhou Jiangsu, 21500, China
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Local Institution - 0179 Changchun Jilin, 13002, China
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Local Institution - 0166 Shenyang Liaoning, 11000, China
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Local Institution - 0160 Xian Shaanxi, 71006, China
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Local Institution - 0169 Jinan Shandong, 25001, China
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Local Institution - 0164 Qingdao Shandong, 26600, China
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Local Institution - 0165 Taiyuan Shanxi, 03003, China
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Local Institution - 0141 Hangzhou Zhejiang, 31000, China
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Local Institution - 0161 Ningbo Zhejiang, 31501, China
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Local Institution - 0170 Zhengzhou , 45000, China
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Local Institution - 0009 Brno Brno-město, 625 0, Czechia
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Fakultni nemocnice Hradec Kralove Hradec Kralove , 500 0, Czechia
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Local Institution - 0045 Praha 2 , 12808, Czechia
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Local Institution - 0115 Aarhus Midtjylland, 8200, Denmark
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Local Institution - 0116 Aalborg Nordjylland, 9000, Denmark
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Local Institution - 0114 Odense Syddanmark, 5000, Denmark
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Centre Hospitalier Universitaire de Nice - Hôpital l'Archet Nice Alpes-Maritimes, 06202, France
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CHU Bordeaux Haut-Leveque Pessac Aquitaine, 33600, France
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Centre Hospitalier Régional Universitaire de Tours - Hôpital Bretonneau Tours Indre-et-Loire, 37032, France
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Centre Hospitalier Universitaire d'Angers Angers Maine-et-Loire, 49933, France
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Hopital Claude Huriez - CHU de Lille Lille Nord, 59000, France
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Gustave Roussy Villejuif Val-de-Marne, 94800, France
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Hôpital Saint-Louis Paris , 75010, France
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Local Institution - 0059 Munich Bayern, 81675, Germany
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Local Institution - 0081 Duisburg Nordrhein-Westfalen, 47166, Germany
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Local Institution - 0128 Düsseldorf Nordrhein-Westfalen, 40479, Germany
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Local Institution - 0055 Leipzig Sachsen, 04103, Germany
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Local Institution - 0037 Dresden , 01307, Germany
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Local Institution - 0007 Hamburg , 22081, Germany
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Local Institution - 0076 Kempten , 87439, Germany
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Local Institution - 0028 Mutlangen , 73557, Germany
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Local Institution - 0125 Chaidari Attikí, 12462, Greece
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Local Institution - 0129 Thessaloniki Thessaloníki, 570 1, Greece
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Local Institution - 0127 Alexandroupolis , 08100, Greece
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Local Institution - 0178 Hksar , 0, Hong Kong
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Local Institution - 0180 Shatin , NT, Hong Kong
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Fondazione Policlinico Tor Vergata Rome Lazio, 00133, Italy
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Fondazione IRCCS Cà Granda Ospedale Maggiore Policlinico Milano Lombardia, 20122, Italy
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Local Institution - 0052 Rozzano Milano, 20089, Italy
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Local Institution - 0075 Firenze Toscana, 50134, Italy
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Azienda Ospedale - Università Padova Padova Veneto, 35128, Italy
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IRCCS Azienda Ospedaliero-Universitaria di Bologna, Policlinico di Sant'Orsola Bologna , 40138, Italy
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Local Institution - 0067 Pavia , 27100, Italy
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Local Institution - 0053 Reggio Calabria , 89133, Italy
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Local Institution - 0143 Roma , 00168, Italy
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Local Institution - 0136 Kitakyushu-shi Fukuoka, 80685, Japan
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Local Institution - 0154 Sapporo Hokkaido, 064-0, Japan
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Local Institution - 0153 Amagasaki Hyogo, 660-8, Japan
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Local Institution - 0130 Sagamihara Kanagawa, 252-0, Japan
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Local Institution - 0135 Sendai-shi Miyagi, 980-8, Japan
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Local Institution - 0150 Shinagawa-ku Tokyo, 141-8, Japan
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Local Institution - 0124 Osaka , 545-8, Japan
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Local Institution - 0058 Hwasun Gun Jeonranamdo, 58128, Korea, Republic of
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Local Institution - 0048 Seoul Seoul Teugbyeolsi, 06591, Korea, Republic of
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Local Institution - 0036 Seoul Seoul-teukbyeolsi [Seoul], 05505, Korea, Republic of
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Local Institution - 0012 Seoul Seoul-teukbyeolsi [Seoul], 06351, Korea, Republic of
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Local Institution - 0051 Jung-gu Taegu-Kwangyǒkshi, 41944, Korea, Republic of
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Local Institution - 0044 Wroclaw Dolnośląskie, 50-36, Poland
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Local Institution - 0097 Olsztyn Warmińsko-mazurskie, 10-22, Poland
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Local Institution - 0043 Katowice , 40-51, Poland
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Local Institution - 0105 Barcelona Barcelona [Barcelona], 08035, Spain
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Local Institution - 0106 L'Hospitalet de Llobregat Catalunya [Cataluña], 08908, Spain
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Local Institution - 0112 Ourense Ourense [Orense], 32005, Spain
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Local Institution - 0109 Valencia Valenciana, Comunitat, 46010, Spain
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Local Institution - 0107 Granada , 18012, Spain
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Local Institution - 0111 Madrid , 28006, Spain
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Local Institution - 0110 Oviedo , 33011, Spain
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Local Institution - 0108 Salamanca , 37007, Spain
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Local Institution - 0117 Lund Skåne Län [se-12], 22185, Sweden
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Karolinska Universitetssjukhuset Huddinge Stockholm Stockholms Län [se-01], 141 8, Sweden
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Local Institution - 0113 Gothenburg Västra Götalands Län [se-14], 413 4, Sweden
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Local Institution - 0119 Örebro Örebro Län [se-18], 701 8, Sweden
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Local Institution - 0077 st.Gallen Sankt Gallen, 9007, Switzerland
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Local Institution - 0066 Basel , 4031, Switzerland
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Local Institution - 0139 Pendik İstanbul, 34899, Turkey
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Local Institution - 0138 İzmir , 35100, Turkey
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Local Institution - 0140 Samsun , 55270, Turkey
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