Myelodysplastic Syndrome Clinical Trial
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).
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 126 Locations for this study
Miami Florida, 33136, United States More Info
Tampa Florida, 33612, United States
Louisville Kentucky, 40202, United States
Detroit Michigan, 48202, United States
New Brunswick New Jersey, 08903, United States
East Syracuse New York, 13057, United States More Info
New York New York, 10065, United States
Charlotte North Carolina, 28204, United States
Portland Oregon, 97239, United States
Charleston South Carolina, 29414, United States
Salt Lake City Utah, 84112, United States
ABB Ciudad Autónoma De Buenos Aires, C1199, Argentina More Info
Contact
Buenos Aires Ciudad Autónoma De Buenos Aires, C1118, Argentina
Buenos Aires , 1431, Argentina
Darlinghurst New South Wales, 2010, Australia
Macquarie University New South Wales, 2109, Australia
Wollongong New South Wales, 2500, Australia
Clayton Victoria, 3168, Australia
Heidelberg Victoria, 3084, Australia
Melbourne Victoria, 3000, Australia
Melbourne Victoria, 3065, Australia
Melbourne , 3004, Australia
Linz Oberösterreich, 4020, Austria
Vienna Wien, 1140, Austria
Salzburg , 5020, Austria
Calgary Alberta, T2N 4, Canada
Toronto Ontario, M4N 3, Canada
Toronto Ontario, M5G 2, Canada
Montréal Quebec, H4A 3, Canada
Guangzhou Guangdong, 51051, China
Wuhan Hubei, 43002, China
Changsha Hunan, 41000, China
Nanjing Jiangsu, 21002, China
Suzhou Jiangsu, 21500, China
Changchun Jilin, 13002, China
Xian Shaanxi, 71006, China
Jinan Shandong, 25001, China
Qingdao Shandong, 26600, China
Taiyuan Shanxi, 03003, China
Hangzhou Zhejiang, 31000, China
Ningbo Zhejiang, 31501, China
Zhengzhou , 45000, China
Brno Brno-město, 625 0, Czechia
Hradec Kralove , 500 0, Czechia
Praha 2 , 12808, Czechia
Aarhus Midtjylland, 8200, Denmark
Aalborg Nordjylland, 9000, Denmark
Odense Syddanmark, 5000, Denmark
Nice Alpes-Maritimes, 06202, France
Pessac Aquitaine, 33600, France
Tours Indre-et-Loire, 37032, France
Angers Maine-et-Loire, 49933, France
Lille Nord, 59000, France
Villejuif Val-de-Marne, 94805, France
Paris , 75010, France
Kempten Bayern, 87439, Germany
Munich Bayern, 81675, Germany
Duisburg Nordrhein-Westfalen, 47166, Germany
Düsseldorf Nordrhein-Westfalen, 40479, Germany
Leipzig Sachsen, 04103, Germany
Dresden , 01307, Germany
Hamburg , 22081, Germany
Mutlangen , 73557, Germany
Milano Lombardia, 20122, Italy
Firenze Toscana, 50134, Italy
Padova Veneto, 35128, Italy
Bologna , 40138, Italy More Info
Pavia , 27100, Italy
Reggio Calabria , 89133, Italy
Roma , 00168, Italy
Kitakyushu-shi Fukuoka, 80685, Japan More Info
Shinagawa-ku Tokyo, 141-8, Japan
Hwasun Gun Jeonranamdo, 58128, Korea, Republic of
Seoul Seoul Teugbyeolsi, 06591, Korea, Republic of
Seoul Seoul-teukbyeolsi [Seoul], 05505, Korea, Republic of
Seoul Seoul-teukbyeolsi [Seoul], 06351, Korea, Republic of
Jung-gu Taegu-Kwangyǒkshi, 41944, Korea, Republic of
Wroclaw Dolnośląskie, 50-36, Poland
Olsztyn Warmińsko-mazurskie, 10-22, Poland
Katowice , 40-51, Poland
Barcelona Barcelona [Barcelona], 08035, Spain
L'Hospitalet de Llobregat Catalunya [Cataluña], 08908, Spain
Valencia Valenciana, Comunitat, 46010, Spain
Granada , 18012, Spain
Madrid , 28006, Spain
Orense , 32005, Spain
Oviedo , 33011, Spain
Salamanca , 37007, Spain
Lund Skåne Län [se-12], 22185, Sweden
Stockholm Stockholms Län [se-01], 141 8, Sweden
Gothenburg Västra Götalands Län [se-14], 413 4, Sweden
Örebro Örebro Län [se-18], 701 8, Sweden
st.Gallen Sankt Gallen, 9007, Switzerland
Basel , 4031, Switzerland
Pendik İstanbul, 34899, Turkey
İzmir , 35100, Turkey
Samsun , 55270, Turkey
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