Spots Global Cancer Trial Database for 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
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Trial Identification
Brief Title: 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
Official Title: A Phase 3, Open-label, Randomized Study to Compare the Efficacy and Safety of Luspatercept (ACE-536) Versus Epoetin Alpha for the Treatment of Anemia Due to IPSS-R Very Low, Low or Intermediate Risk Due to Myelodysplastic Syndrome (MDS) ESA in Native Subjects Who Require Red Blood Cell Transfusions
Study ID: NCT03682536
Conditions
Study Description
Brief 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).
Detailed Description:
Eligibility
Minimum Age: 18 Years
Eligible Ages: ADULT, OLDER_ADULT
Sex: ALL
Healthy Volunteers: No
Locations
Local Institution - 107, Berkeley, California, United States
Local Institution - 115, San Diego, California, United States
Local Institution - 101, Whittier, California, United States
Local Institution - 104, New Haven, Connecticut, United States
Local Institution - 136, Washington, District of Columbia, United States
Local Institution - 119, Hudson, Florida, United States
Local Institution - 120, Saint Petersburg, Florida, United States
Local Institution - 122, Tallahassee, Florida, United States
Local Institution - 108, Tampa, Florida, United States
Local Institution - 118, West Palm Beach, Florida, United States
Local Institution - 102, Paducah, Kentucky, United States
Local Institution - 123, Bethesda, Maryland, United States
Local Institution - 117, Kansas City, Missouri, United States
Local Institution - 134, East Brunswick, New Jersey, United States
Local Institution - 113, Hackensack, New Jersey, United States
Local Institution - 105, Greenville, North Carolina, United States
Local Institution - 131, Portland, Oregon, United States
Univ of Pittsburgh Medical Center, Pittsburgh, Pennsylvania, United States
Local Institution - 111, Rock Hill, South Carolina, United States
Tennessee Oncology, Nashville, Tennessee, United States
Baylor University Medical Center, Dallas, Texas, United States
Local Institution - 109, Houston, Texas, United States
Utah Cancer Specialists - South Salt Lake, Salt Lake City, Utah, United States
Local Institution - 132, Charlottesville, Virginia, United States
Local Institution - 127, Chesapeake, Virginia, United States
Local Institution - 206, Albury, New South Wales, Australia
Local Institution - 213, Blacktown, New South Wales, Australia
Local Institution - 200, Concord, New South Wales, Australia
Local Institution - 215, Kogarah, New South Wales, Australia
Local Institution - 211, Nowra, New South Wales, Australia
Local Institution - 210, Waratah, New South Wales, Australia
Local Institution - 207, Wollongong, New South Wales, Australia
Local Institution - 208, Auchenflower, Queensland, Australia
Local Institution - 202, Adelaide, South Australia, Australia
Local Institution - 204, Clayton, Victoria, Australia
Local Institution - 203, Malvern, Victoria, Australia
Local Institution - 209, Melbourne, Victoria, Australia
Local Institution - 205, West Perth, Western Australia, Australia
Local Institution - 212, Randwick, , Australia
Local Institution - 442, Linz, , Austria
Local Institution - 441, Vienna, , Austria
Local Institution - 475, Antwerpen, , Belgium
Local Institution - 471, Brasschaat, , Belgium
Local Institution - 474, Brussels, , Belgium
Local Institution - 472, Charleroi, , Belgium
Local Institution - 473, Kortrijk, , Belgium
Local Institution - 470, Leuven, , Belgium
Local Institution - 476, Roeselare, , Belgium
Local Institution - 147, Calgary, Alberta, Canada
Local Institution - 145, Edmonton, Alberta, Canada
Local Institution - 142, Hamilton, Ontario, Canada
Local Institution - 140, Ottawa, Ontario, Canada
Local Institution - 141, Toronto, Ontario, Canada
Local Institution - 144, Montreal, Quebec, Canada
Local Institution - 148, Montreal, Quebec, Canada
Local Institution - 151, Saskatoon, Saskatchewan, Canada
Local Institution - 152, Sherbrooke, , Canada
Local Institution - 560, Hradec Kralove, , Czechia
Local Institution - 564, Ostrava-Poruba, , Czechia
Local Institution - 563, Prague 10, , Czechia
Local Institution - 562, Praha 2, , Czechia
Local Institution - 561, Praha, , Czechia
Local Institution - 317, Angers, , France
Local Institution - 312, Bayonne, , France
Local Institution - 311, Caen Cedex 9, , France
Local Institution - 306, La Tronche, , France
Local Institution - 305, Le Mans, , France
Local Institution - 309, Lille, , France
Local Institution - 303, Limoges Cedex, , France
Local Institution - 307, Nantes Cedex 01, , France
Local Institution - 301, Nice Cedex 3, , France
Local Institution - 302, Paris, , France
Local Institution - 313, Paris, , France
Local Institution - 308, Pessac, , France
Local Institution - 315, Pierre Bénite, , France
Local Institution - 316, Poitiers, , France
Local Institution - 314, Strasbourg, , France
Local Institution - 300, Toulouse, , France
Local Institution - 310, Tours cedex, , France
Local Institution - 304, Vandoeuvre les Nancy, , France
Local Institution - 422, Baden-Warttemberg, , Germany
Local Institution - 424, Berlin, , Germany
Local Institution - 426, Dresden, , Germany
Local Institution - 429, Duisburg, , Germany
Local Institution - 420, Dusseldorf, , Germany
Local Institution - 431, Hamburg, , Germany
Local Institution - 435, Keil, , Germany
Local Institution - 423, Koblenz, , Germany
Local Institution - 428, Köln, , Germany
Local Institution - 430, Leipzig, , Germany
Local Institution - 436, Mannheim, , Germany
Local Institution - 421, Munchen, , Germany
Local Institution - 425, Winnenden, , Germany
Local Institution - 427, Würzburg, , Germany
Local Institution - 389, Heraklion, Irakleio, Greece
Local Institution - 396, Alexandroupolis, , Greece
Local Institution - 397, Athens, , Greece
Local Institution - 391, Athens, , Greece
Local Institution - 392, Athens, , Greece
Local Institution - 395, Athina, , Greece
Local Institution - 398, Patras, , Greece
Local Institution - 393, Rio Patras, , Greece
Local Institution - 399, Thessaloniki, , Greece
Local Institution - 390, Thessaloniki, , Greece
Local Institution - 535, Budapest, , Hungary
Local Institution - 534, Debrecen, , Hungary
Local Institution - 536, Nyiregyhaza, , Hungary
Local Institution - 386, Haifa, , Israel
Local Institution - 383, Jerusalem, , Israel
Local Institution - 384, Jerusalem, , Israel
Local Institution - 381, Kfar-Saba, , Israel
Local Institution - 385, Nahariya, , Israel
Local Institution - 382, Tel Aviv, , Israel
Local Institution - 380, Zerifin, , Israel
Local Institution - 331, Orbassano, TO, Italy
Local Institution - 324, Bologna, , Italy
Local Institution - 327, Firenze, , Italy
Local Institution - 330, Meldola, , Italy
Local Institution - 321, Milano, , Italy
Local Institution - 329, Padova, , Italy
Local Institution - 326, Reggio Di Calabria, , Italy
Local Institution - 328, Roma, , Italy
Local Institution - 332, Roma, , Italy
Local Institution - 325, Rome, , Italy
Local Institution - 323, Rozzano, , Italy
Local Institution - 322, Udine, , Italy
Local Institution - 238, Matsuyama, Ehime, Japan
Local Institution - 244, Nagasaki-shi, Nagasaki, Japan
Local Institution - 236, Osakasayama, Osaka, Japan
Local Institution - 247, Amagasaki-Shi, , Japan
Local Institution - 249, Fujisawa-Shi, , Japan
Local Institution - 234, Fukuoka, , Japan
Local Institution - 237, Hitachi, Ibaraki, , Japan
Local Institution - 231, Kamogawa, , Japan
Local Institution - 248, Kitakyushu-Shi, , Japan
Local Institution - 270, Nagaoka-Shi, , Japan
Local Institution - 243, Nagoya-shi, , Japan
Local Institution - 241, Ogaki, , Japan
Local Institution - 235, Okayama, , Japan
Local Institution - 242, Osaka, , Japan
Local Institution - 233, Sagamihara, , Japan
Local Institution - 246, Sapporo-shi, , Japan
Local Institution - 239, Sendai, , Japan
Local Institution - 232, Shibuya-ku, , Japan
Local Institution - 245, Shimotsuga-gun, , Japan
Local Institution - 230, Shinagawa-ku, Tokyo, , Japan
Local Institution - 251, Busan, , Korea, Republic of
Local Institution - 257, Daegu, , Korea, Republic of
Local Institution - 250, Hwasun-Gun, , Korea, Republic of
Local Institution - 253, Seongnam-si, , Korea, Republic of
Local Institution - 252, Seoul, , Korea, Republic of
Local Institution - 256, Seoul, , Korea, Republic of
Local Institution - 255, Seoul, , Korea, Republic of
Local Institution - 254, Seoul, , Korea, Republic of
Local Institution - 540, Kaunas, , Lithuania
Local Institution - 541, Vilnius, , Lithuania
Local Institution - 462, Amsterdam, , Netherlands
Local Institution - 461, Den Haag, , Netherlands
Local Institution - 464, Nijmegen, , Netherlands
Local Institution - 460, Rotterdam, , Netherlands
Local Institution - 463, Sittard-Geleen, , Netherlands
Local Institution - 570, Lodz, Lódzkie, Poland
Local Institution - 575, Gdansk, , Poland
Local Institution - 572, Lubin, , Poland
Local Institution - 576, Poznan, , Poland
Local Institution - 573, Rzwszow, , Poland
Local Institution - 579, Slupsk, , Poland
Local Institution - 578, Walbrzych, , Poland
Local Institution - 577, Wroclaw, , Poland
Local Institution - 571, Wroclaw, , Poland
Local Institution - 373, Beja, , Portugal
Local Institution - 371, Braga, , Portugal
Local Institution - 372, Lisboa, , Portugal
Local Institution - 370, Porto, , Portugal
Local Institution - 374, Setubal, , Portugal
Local Institution - 511, Kaluga, , Russian Federation
Local Institution - 505, Kirov, , Russian Federation
Local Institution - 509, Krasnoyarsk, , Russian Federation
Local Institution - 504, Moscow, , Russian Federation
Local Institution - 507, Moscow, , Russian Federation
Local Institution - 500, Moscow, , Russian Federation
Local Institution - 503, Moscow, , Russian Federation
Local Institution - 508, Saratov, , Russian Federation
Local Institution - 506, St Petersburg, , Russian Federation
Local Institution - 510, St. Petersburg, , Russian Federation
Local Institution - 502, Tula, , Russian Federation
Local Institution - 358, Barcelona, , Spain
Local Institution - 350, Barcelona, , Spain
Local Institution - 354, Granada, , Spain
Local Institution - 352, Madrid, , Spain
Local Institution - 355, Madrid, , Spain
Local Institution - 353, Malaga, , Spain
Local Institution - 361, Murcia, , Spain
Local Institution - 356, Ourense, , Spain
Local Institution - 363, Oviedo, , Spain
Local Institution - 362, Palma de Mallorca, , Spain
Local Institution - 351, Salamanca, , Spain
Local Institution - 360, Seville, , Spain
Local Institution - 357, Valencia, , Spain
Local Institution - 359, Valencia, , Spain
Local Institution - 550, Goteborg, , Sweden
Local Institution - 552, Lund, , Sweden
Local Institution - 551, Stockholm, , Sweden
Local Institution - 450, Bern, , Switzerland
Local Institution - 452, Luzern 16, , Switzerland
Local Institution - 451, Winterthur, , Switzerland
Local Institution - 220, Changhua City, Changhua, , Taiwan
Local Institution - 222, Niaosong District Kaohsiung City, , Taiwan
Local Institution - 223, Taichung City, , Taiwan
Local Institution - 224, Taichung, , Taiwan
Local Institution - 221, Taipei, Zhongzheng Dist., , Taiwan
Local Institution - 342, Ankara, , Turkey
Local Institution - 340, Manisa, , Turkey
Local Institution - 343, Trabzon, , Turkey
Local Institution - 526, Cherkassy, , Ukraine
Local Institution - 525, Dnipro, , Ukraine
Local Institution - 522, Kyiv, , Ukraine
Local Institution - 520, Lvov, , Ukraine
Local Institution - 523, Mykolaiv, , Ukraine
Local Institution - 521, Ternopil, , Ukraine
Local Institution - 401, Aberdeen, , United Kingdom
Local Institution - 403, Bournemouth, , United Kingdom
Local Institution - 405, Headington, Oxford, , United Kingdom
Local Institution - 407, Lincoln, , United Kingdom
Local Institution - 404, London, , United Kingdom
Local Institution - 400, Manchester, , United Kingdom
Contact Details
Name: Bristol-Myers Squibb
Affiliation: Bristol-Myers Squibb
Role: STUDY_DIRECTOR
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