Myelodysplastic Syndrome Clinical Trial
A Study to Compare the Efficacy and Safety of Luspatercept (ACE-536) Versus Epoetin Alfa for the Treatment of Anemia Due to IPSS-R Very Low, Low, or Intermediate Risk Myelodysplastic Syndromes (MDS) Participants Who Require Red Blood Cell Transfusions and Are ESA Naïve
Summary
The purpose of this study is to determine the effectiveness of luspatercept (ACE-536) compared to epoetin alfa on red blood cell (RBC) transfusion independence (for at least 12 weeks) with a concurrent hemoglobin increase of at least 1.5 g/dL in participants with anemia due to revised international prognostic scoring system (IPSS-R) very low, low, or intermediate risk myelodysplastic syndromes (MDS) who require RBC transfusions and have never been exposed to erythropoiesis stimulating agent (ESA).
Eligibility Criteria
Inclusion Criteria:
Documented diagnosis of Myelodysplastic syndromes (MDS) according to WHO 2016 classification that meets revised international prognostic scoring system (IPSS-R) classification of very low, low, or intermediate risk disease, and have < 5% blasts in bone marrow
Endogenous serum erythropoietin (sEPO) level of < 500 U/L
Requires Red blood cell (RBC) transfusions, as documented by the criteria: Average transfusion requirement of 2 - 6 units/8 weeks of packed red blood cells (pRBCs) confirmed for a minimum of 8 weeks immediately preceding randomization
Eastern Cooperative Oncology Group (ECOG) score of 0, 1, or 2
Exclusion Criteria:
Clinically significant anemia due to iron, vitamin B12, or folate deficiencies, or autoimmune or hereditary hemolytic anemia, or hypothyroidism, or any type of known clinically significant bleeding or sequestration or drug induced anemia
Known history of diagnosis of Acute myeloid leukemia (AML)
Uncontrolled hypertension, defined as repeated elevations of systolic blood pressure (SBP) of ≥ 150 mmHg and/or diastolic blood pressure (DBP) ≥ 100 mmHg despite adequate treatment
Other protocol-defined inclusion/exclusion criteria apply
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There are 223 Locations for this study
Berkeley California, 94704, United States
San Diego California, 92123, United States
Whittier California, 90603, United States
New Haven Connecticut, 06520, United States
Washington District of Columbia, 20422, United States
Hudson Florida, 34667, United States
Saint Petersburg Florida, 33705, United States
Tallahassee Florida, 32308, United States
Tampa Florida, 33612, United States
West Palm Beach Florida, 33401, United States
Paducah Kentucky, 42003, United States
Bethesda Maryland, 20817, United States
Kansas City Missouri, 64132, United States
East Brunswick New Jersey, 08816, United States
Hackensack New Jersey, 07601, United States
Greenville North Carolina, 27858, United States
Portland Oregon, 97213, United States
Pittsburgh Pennsylvania, 15232, United States
Rock Hill South Carolina, 29732, United States
Nashville Tennessee, 37203, United States
Dallas Texas, 75246, United States
Houston Texas, 77030, United States
Salt Lake City Utah, 84106, United States
Charlottesville Virginia, 22903, United States
Chesapeake Virginia, 23320, United States
Albury New South Wales, 2640, Australia
Blacktown New South Wales, 2148, Australia
Concord New South Wales, 2139, Australia
Kogarah New South Wales, 2217, Australia
Nowra New South Wales, 2541, Australia
Waratah New South Wales, 2298, Australia
Wollongong New South Wales, 2500, Australia
Auchenflower Queensland, 4066, Australia
Adelaide South Australia, 5000, Australia
Clayton Victoria, 3168, Australia
Malvern Victoria, 3144, Australia
Melbourne Victoria, 3004, Australia
West Perth Western Australia, 6005, Australia
Randwick , 2031, Australia
Linz , 4020, Austria
Vienna , 1090, Austria
Antwerpen , 2020, Belgium
Brasschaat , 2930, Belgium
Brussels , 1200, Belgium
Charleroi , 6000, Belgium
Kortrijk , 8500, Belgium
Leuven , 3000, Belgium
Roeselare , 8800, Belgium
Calgary Alberta, T2N 4, Canada
Edmonton Alberta, T6G 2, Canada
Hamilton Ontario, L8V 5, Canada
Ottawa Ontario, K1H 8, Canada
Toronto Ontario, M4N 3, Canada
Montreal Quebec, H1T 2, Canada
Montreal Quebec, H3T 1, Canada
Saskatoon Saskatchewan, S7N 4, Canada
Sherbrooke , J1H 5, Canada
Hradec Kralove , 500 0, Czechia
Ostrava-Poruba , 708 5, Czechia
Prague 10 , 100 3, Czechia
Praha 2 , 128 0, Czechia
Praha , 128 2, Czechia
Angers , 49000, France
Bayonne , 64109, France
Caen Cedex 9 , 14033, France
La Tronche , 38700, France
Le Mans , 72037, France
Lille , 59037, France
Limoges Cedex , 87042, France
Nantes Cedex 01 , 44093, France
Nice Cedex 3 , 06200, France
Paris , 75010, France
Paris , 75014, France
Pessac , 33604, France
Pierre Bénite , 69495, France
Poitiers , 86021, France
Strasbourg , 67033, France
Toulouse , 31059, France
Tours cedex , 37044, France
Vandoeuvre les Nancy , 54511, France
Baden-Warttemberg , 73557, Germany
Berlin , 14195, Germany
Dresden , 01307, Germany
Duisburg , 47166, Germany
Dusseldorf , 40479, Germany
Hamburg , 22081, Germany
Keil , 24105, Germany
Koblenz , 56068, Germany
Köln , 50677, Germany
Leipzig , 04103, Germany
Mannheim , 68167, Germany
Munchen , 81675, Germany
Winnenden , 71364, Germany
Würzburg , 97070, Germany
Heraklion Irakleio, 71110, Greece
Alexandroupolis , 08100, Greece
Athens , 10676, Greece
Athens , 115 2, Greece
Athens , 12464, Greece
Athina , 115 2, Greece
Patras , 26500, Greece
Rio Patras , 26500, Greece
Thessaloniki , 546 3, Greece
Thessaloniki , 57010, Greece
Budapest , 1096, Hungary
Debrecen , 4032, Hungary
Nyiregyhaza , 4400, Hungary
Haifa , 34362, Israel
Jerusalem , 91031, Israel
Jerusalem , 91120, Israel
Kfar-Saba , 44281, Israel
Nahariya , 22100, Israel
Tel Aviv , 64239, Israel
Zerifin , 70300, Israel
Orbassano TO, 10043, Italy
Bologna , 40138, Italy
Firenze , 50134, Italy
Meldola , 47014, Italy
Milano , 20162, Italy
Padova , 35128, Italy
Reggio Di Calabria , 89124, Italy
Roma , 00133, Italy
Roma , 00189, Italy
Rome , 00161, Italy
Rozzano , 20089, Italy
Udine , 33100, Italy
Matsuyama Ehime, 790-8, Japan
Nagasaki-shi Nagasaki, 852-8, Japan
Osakasayama Osaka, 58985, Japan
Amagasaki-Shi , 660-0, Japan
Fujisawa-Shi , 251-0, Japan
Fukuoka , 810-8, Japan
Hitachi, Ibaraki , 317-0, Japan
Kamogawa , 296-8, Japan
Kitakyushu-Shi , 806-0, Japan
Nagaoka-Shi , 940-2, Japan
Nagoya-shi , 460-0, Japan
Ogaki , 503-8, Japan
Okayama , 700-8, Japan
Osaka , 545-8, Japan
Sagamihara , 252-0, Japan
Sapporo-shi , 064-0, Japan
Sendai , 980-8, Japan
Shibuya-ku , 150-8, Japan
Shimotsuga-gun , 321-0, Japan
Shinagawa-ku, Tokyo , 141-8, Japan
Busan , 49241, Korea, Republic of
Daegu , 700-7, Korea, Republic of
Hwasun-Gun , 58128, Korea, Republic of
Seongnam-si , 13620, Korea, Republic of
Seoul , 06351, Korea, Republic of
Seoul , 06591, Korea, Republic of
Seoul , 3080, Korea, Republic of
Seoul , 5505, Korea, Republic of
Kaunas , LT-50, Lithuania
Vilnius , LT-08, Lithuania
Amsterdam , 1081 , Netherlands
Den Haag , 2545 , Netherlands
Nijmegen , 6525 , Netherlands
Rotterdam , 3015 , Netherlands
Sittard-Geleen , 6162 , Netherlands
Lodz Lódzkie, 93-51, Poland
Gdansk , 80-95, Poland
Lubin , 20-08, Poland
Poznan , 60-56, Poland
Rzwszow , 35-05, Poland
Slupsk , 76-20, Poland
Walbrzych , 58-30, Poland
Wroclaw , 50-36, Poland
Wroclaw , 50-55, Poland
Beja , 7801-, Portugal
Braga , 4710-, Portugal
Lisboa , 1099-, Portugal
Porto , 4200-, Portugal
Setubal , 2910-, Portugal
Kaluga , 24800, Russian Federation
Kirov , 61002, Russian Federation
Krasnoyarsk , 66002, Russian Federation
Moscow , 11112, Russian Federation
Moscow , 12318, Russian Federation
Moscow , 12528, Russian Federation
Moscow , 12930, Russian Federation
Saratov , 41001, Russian Federation
St Petersburg , 19734, Russian Federation
St. Petersburg , 19702, Russian Federation
Tula , 30005, Russian Federation
Barcelona , 08035, Spain
Barcelona , 08908, Spain
Granada , 18014, Spain
Madrid , 28007, Spain
Madrid , 28041, Spain
Malaga , 29010, Spain
Murcia , 30008, Spain
Ourense , 32005, Spain
Oviedo , 33011, Spain
Palma de Mallorca , 7120, Spain
Salamanca , 37007, Spain
Seville , 41013, Spain
Valencia , 46010, Spain
Valencia , 46026, Spain
Goteborg , SE-41, Sweden
Lund , SE-22, Sweden
Stockholm , SE-14, Sweden
Bern , 3010, Switzerland
Luzern 16 , 6000, Switzerland
Winterthur , 8400, Switzerland
Changhua City, Changhua , 500, Taiwan
Niaosong District Kaohsiung City , 83301, Taiwan
Taichung City , 40447, Taiwan
Taichung , 40705, Taiwan
Taipei, Zhongzheng Dist. , 10002, Taiwan
Ankara , 06100, Turkey
Manisa , 45030, Turkey
Trabzon , 61080, Turkey
Cherkassy , 18009, Ukraine
Dnipro , 49102, Ukraine
Kyiv , 3115, Ukraine
Lvov , 79044, Ukraine
Mykolaiv , 54058, Ukraine
Ternopil , 46002, Ukraine
Aberdeen , AB25 , United Kingdom
Bournemouth , BH7 7, United Kingdom
Headington, Oxford , OX3 7, United Kingdom
Lincoln , LN2 5, United Kingdom
London , SE5 9, United Kingdom
Manchester , M20 4, United Kingdom
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