Myelodysplastic Syndrome Clinical Trial
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)
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).
Eligibility Criteria
Inclusion Criteria:
18 years or older
Have a documented diagnosis of MDS
Anemia that requires red blood cell transfusions
Thrombocytopenia (sustained for at least 21 days) within 14 days prior to randomization
Have an Eastern Cooperative Oncology Group (ECOG) performance status of 0, 1, or 2
Must agree to follow pregnancy precautions as required by protocol.
Understand and voluntarily sign an informed consent document prior to any study related assessments/procedures being conducted
Exclusion Criteria:
Secondary or hypoplastic MDS or other subtype with eligibility for treatment with immunotherapy
Prior treatment with azacitidine, decitabine, other hypomethylating agents and lenalidomide (for lenalidomide : unless the last dose received is >= 8 weeks prior to inclusion into the study).
Prior allogeneic or autologous stem cell transplant
Eligible for allogenic or autologous stem cell transplant
History of inflammatory bowel disease (eg, Crohn's disease, ulcerative colitis), celiac disease (ie, sprue), prior gastrectomy or upper bowel removal, or any other gastrointestinal disorder or defect
Thrombocytopenia secondary to other possible causes, including medication(s), congenital disorder(s), immune disorder(s), or microvascular disorder(s)
Use of cytotoxic, chemotherapeutic, targeted or investigational agents/therapies, thrombopoiesis-stimulating agents (TSAs), erythropoiesis-stimulating agents (ESAs) and other red blood cell hematopoietic growth factors, and within 28 days prior to randomization
Ongoing medically significant adverse events from previous treatment, regardless of the time period
Concurrent use of iron-chelating agents, (except for subjects on a stable or decreasing dose for at least 8 weeks (56 days) prior to randomization), corticosteroid (except for subjects on a stable or decreasing dose for ≥ 1 week prior to randomization for medical conditions other than MDS)
Prior history of cancer, other than MDS, unless the subject has been free of the disease for ≥ 3 years. (Basal or squamous cell carcinoma of the skin, carcinoma in situ of the cervix, carcinoma in situ of the breast, and incidental histologic finding of prostate cancer) (T1a or T1b using the tumor, nodes, metastasis [TNM] clinical staging system is allowed)
Significant active cardiac disease within the previous 6 months
Uncontrolled systemic fungal, bacterial, or viral infection
Known Human Immunodeficiency Virus (HIV) or Hepatitis C (HCV) infection, or evidence of active Hepatitis B Virus (HBV) infection
Known clinically significant anemia due to iron, vitamin B12, or folate deficiencies, or autoimmune or hereditary hemolytic anemia, or gastrointestinal bleeding
Abnormal coagulation parameters
Abnormal liver function test results
Abnormal kidney function test results
Known or suspected hypersensitivity to azacitidine or mannitol
Any significant medical condition, laboratory abnormality, or psychiatric illness
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There are 192 Locations for this study
Berkeley California, 94704, United States
Beverly Hills California, 90211, United States
Duarte California, 91010, United States
Escondido California, 92025, United States
Greenbrae California, 94904, United States
La Jolla California, 92093, United States
Los Angeles California, 90033, United States
New Haven Connecticut, 06519, United States
Orlando Florida, 32806, United States
Albany Georgia, 31701, United States
Chicago Illinois, 60611, United States
Chicago Illinois, 60612, United States
Chicago Illinois, 60637, United States
Maywood Illinois, 60153, United States
Kansas City Kansas, 66160, United States
Louisville Kentucky, 40202, United States
Metairie Louisiana, 70006, United States
Baltimore Maryland, 21231, United States
Worcester Massachusetts, 01655, United States
Rochester Minnesota, 55905, United States
Jackson Mississippi, 39202, United States
Kansas City Missouri, 64111, United States
Kansas City Missouri, 64128, United States
Omaha Nebraska, 68198, United States
New York New York, 10021, United States
New York New York, 10029, United States
Charlotte North Carolina, 28204, United States
Greenville North Carolina, 27834, United States
Cleveland Ohio, 44106, United States
Columbus Ohio, 43210, United States
Portland Oregon, 97227, United States
Philadelphia Pennsylvania, 19104, United States
Pittsburgh Pennsylvania, 15224, United States
Fort Sam Houston Texas, 78235, United States
Houston Texas, 77030, United States
Houston Texas, 77030, United States
Houston Texas, 77090, United States
Richmond Virginia, 23298, United States
Seattle Washington, 98109, United States
Waukesha Wisconsin, 53188, United States
Garran Australian Capital Territory, 2605, Australia
Adelaide South Australia, SA 50, Australia
Clayton Victoria, 3168, Australia
Frankston Victoria, 3199, Australia
Camperdown , 2050, Australia
Epping, VIC , 3076, Australia
Fitzroy , 3065, Australia
Kogarah , 2217, Australia
Malvern , 3144, Australia
Milton, Brisbane , 4064, Australia
Waratah , NSW, Australia
Woolloongabba , QLD 4, Australia
Brasschaat , 2930, Belgium
Brugge , 8000, Belgium
Charleroi , 6000, Belgium
Leuven , 3000, Belgium
Fortaleza Ceará, 60430, Brazil
Curitiba Paraná, 81520, Brazil
Porto Alegre Rio Grande Do Sul, 90035, Brazil
Rio De Janeiro , 20231, Brazil
Sao Paulo , 05651, Brazil
Edmonton Alberta, T6G 2, Canada
Vancouver British Columbia, V5Z 1, Canada
Barrie Ontario, LYM6M, Canada
Hamilton Ontario, L8V 5, Canada
Toronto Ontario, M4N 3, Canada
Toronto Ontario, M5G 2, Canada
Montreal Quebec, H2W 1, Canada
Montreal Quebec, H4J 1, Canada
Brno Jihomoravský Kraj, 625 0, Czechia
Hradec Králové , 500 0, Czechia
Olomouc , 77520, Czechia
Praha , 128 0, Czechia
Praha , 128 2, Czechia
Aarhus , 8000, Denmark
Odense C , 5000, Denmark
Roskilde , DK-40, Denmark
Helsinki , 00029, Finland
Turku , 20521, Finland
Lille , 59037, France
Marseille Cedex 9 , 13009, France
Nantes , 44093, France
Paris , 7575, France
Pierre-Bénite Cedex , 69495, France
Rennes Cedex , 35033, France
Rouen Cedex , 76038, France
Strasbourg , 67091, France
Toulouse Cedex 9 , 31059, France
Tours , 37044, France
Dresden , 01307, Germany
Dresden , 01307, Germany
Duesseldorf , 40479, Germany
Dusseldorf , 40225, Germany
Hamburg , D-200, Germany
Keil , 24105, Germany
Leipzig , 04103, Germany
München , 81675, Germany
Tubingen , 72076, Germany
Ulm , 89081, Germany
Heraklion Irakleio, 71110, Greece
Alexandroupolis , 68100, Greece
Athens , 10676, Greece
Athens , 115 2, Greece
Athens , 124 6, Greece
Patras , 26500, Greece
Haifa , 31096, Israel
Petach Tikva , 49100, Israel
Tel Hashomer , 52621, Israel
Tel-Aviv , 64239, Israel
Alessandria , 15121, Italy
Bari , 70124, Italy
Bologna , 40138, Italy
Cagliari , 09121, Italy
Firenze , 50129, Italy
Lecce , 73100, Italy
Milano , 20122, Italy
Milan , 20089, Italy
Novara , 28100, Italy
Palermo , 90146, Italy
Pavia , 27100, Italy
Pisa , 56126, Italy
Reggio Calabria , 89133, Italy
Rionero in Vulture , 85028, Italy
Roma , 00133, Italy
Roma , 00161, Italy
Roma , 00168, Italy
Terni , 05100, Italy
Torino , 10126, Italy
Torrette Di Ancona , 60020, Italy
Udine , 33100, Italy
Venezia - Mestre , 30174, Italy
Busan , 614-7, Korea, Republic of
Daegu , 700-7, Korea, Republic of
Seoul , 06591, Korea, Republic of
Seoul , 120-7, Korea, Republic of
Seoul , 135-7, Korea, Republic of
Huixquilucan de Degollado , 52763, Mexico
Monterrey , 64460, Mexico
Monterrey , 64710, Mexico
Tlalpan , 14080, Mexico
Amsterdam , 1081 , Netherlands
Groningen , 9713 , Netherlands
Nijmegen , 6500 , Netherlands
Rotterdam , 3075 , Netherlands
Førde , 6807, Norway
Oslo , N-002, Norway
Bydgoszcz , 85-16, Poland
Gdansk , 80-95, Poland
Krakow , 31-50, Poland
Lodz , 93-51, Poland
Torun , 87-10, Poland
Warszawa , 02-09, Poland
Warszawa , 02-77, Poland
Wroclaw , 50-36, Poland
Beja , 7801-, Portugal
Coimbra , 3000-, Portugal
Lisboa , 1099-, Portugal
Lisboa , 1150-, Portugal
Porto , 4200-, Portugal
Badalona (Barcelona) , 8916, Spain
Barcelona , 08025, Spain
Barcelona , 8035, Spain
Granada , 18014, Spain
Madrid , 28009, Spain
Madrid , 28034, Spain
Madrid , 28046, Spain
Malaga , 29010, Spain
Oviedo , 33006, Spain
Salamanca , 37007, Spain
Seville , 41013, Spain
Vitoria-Gasteiz, Álava , 1009, Spain
Goeteborg , 413 4, Sweden
Lund , 222 4, Sweden
Stockholm , 14186, Sweden
Adana , 01250, Turkey
Antalya , 07100, Turkey
Istanbul , 34098, Turkey
Istanbul , 34390, Turkey
Mersin , 33343, Turkey
Trabzon , 61080, Turkey
Oxford Oxfordshire, OX3 9, United Kingdom
Aberdeen , AB25 , United Kingdom
Birmingham , B9 5S, United Kingdom
Bristol , BS2 8, United Kingdom
Cambridge , CB2 0, United Kingdom
Cardiff , CF14 , United Kingdom
Harrow Middlesex , HA1 3, United Kingdom
Hull , HU16 , United Kingdom
Leicester , LE1 5, United Kingdom
Liverpool , L7 8X, United Kingdom
London , EC1A , United Kingdom
London , SE1 9, United Kingdom
Manchester , M13 9, United Kingdom
Nottingham , NG5 1, United Kingdom
Sutton in Ashfield , NG17 , United Kingdom
Wolverhampton , WV10 , United Kingdom
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