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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
Sponsor: Celgene
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).
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) in ESA Naïve Subjects Who Require Red Blood Cell Transfusions
Key Details
Gender
All
Age Range
18 Years - Any
Study Type
INTERVENTIONAL
Enrollment
363
Start Date
2019-01-02
Completion Date
2027-09-28
Last Updated
2024-11-20
Healthy Volunteers
No
Conditions
Interventions
Luspatercept
Specified dose on specified days
Epoetin alfa
Specified dose on specified days
Locations (226)
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 D.C., District of Columbia, United States
Local Institution - 119
Hudson, Florida, United States
Local Institution - 120
St. 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
Local Institution - 114
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
Antwerp, 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 Králové, Czechia
Local Institution - 564
Ostrava-Poruba, Czechia
Local Institution - 563
Prague, Czechia
Local Institution - 562
Prague, Czechia
Local Institution - 561
Prague, Czechia
Local Institution - 317
Angers, France
Local Institution - 312
Bayonne, France
Local Institution - 311
Caen, France
Local Institution - 306
La Tronche, France
Local Institution - 305
Le Mans, France
Local Institution - 309
Lille, France
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Limoges, France
Local Institution - 307
Nantes, France
Local Institution - 301
Nice, France
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Paris, France
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Paris, France
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Pessac, France
Local Institution - 315
Pierre-Bénite, France
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Poitiers, France
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Strasbourg, France
Local Institution - 300
Toulouse, France
Local Institution - 310
Tours, France
Local Institution - 304
Vandœuvre-lès-Nancy, France
Local Institution - 422
Baden-Warttemberg, Germany
Local Institution - 424
Berlin, Germany
Local Institution - 428
Cologne, Germany
Local Institution - 426
Dresden, Germany
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Duisburg, Germany
Local Institution - 420
Düsseldorf, Germany
Local Institution - 431
Hamburg, Germany
Local Institution - 435
Keil, Germany
Local Institution - 423
Koblenz, Germany
Local Institution - 430
Leipzig, Germany
Local Institution - 436
Mannheim, Germany
Local Institution - 421
München, Germany
Local Institution - 425
Winnenden, Germany
Local Institution - 427
Würzburg, Germany
Local Institution - 389
Heraklion, Irakleio, Greece
Local Institution - 396
Alexandroupoli, Greece
Local Institution - 397
Athens, Greece
Local Institution - 391
Athens, Greece
Local Institution - 395
Athens, Greece
Local Institution - 392
Athens, Greece
Local Institution - 398
Pátrai, 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
Nyíregyháza, 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
Ẕerifin, Israel
Local Institution - 331
Orbassano, TO, Italy
Local Institution - 324
Bologna, Italy
Local Institution - 327
Florence, Italy
Local Institution - 330
Meldola, Italy
Local Institution - 321
Milan, Italy
Local Institution - 329
Padova, Italy
Local Institution - 326
Reggio 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, Nagasaki, Japan
Local Institution - 236
Sayama, 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, Japan
Local Institution - 235
Okayama, Japan
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Osaka, Japan
Local Institution - 241
Ōgaki, Japan
Local Institution - 233
Sagamihara, Japan
Local Institution - 246
Sapporo, 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 - 540
Kaunas, Lithuania
Local Institution - 541
Vilnius, Lithuania
Local Institution - 462
Amsterdam, Netherlands
Local Institution - 464
Nijmegen, Netherlands
Local Institution - 460
Rotterdam, Netherlands
Local Institution - 463
Sittard-Geleen, Netherlands
Local Institution - 461
The Hague, 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
Słupsk, Poland
Local Institution - 578
Wałbrzych, Poland
Local Institution - 577
Wroclaw, Poland
Local Institution - 571
Wroclaw, Poland
Local Institution - 373
Beja, Portugal
Local Institution - 371
Braga, Portugal
Local Institution - 372
Lisbon, Portugal
Local Institution - 370
Porto, Portugal
Local Institution - 374
Setúbal, Portugal
Local Institution - 511
Kaluga, Russia
Local Institution - 505
Kirov, Russia
Local Institution - 509
Krasnoyarsk, Russia
Local Institution - 504
Moscow, Russia
Local Institution - 507
Moscow, Russia
Local Institution - 500
Moscow, Russia
Local Institution - 503
Moscow, Russia
Local Institution - 510
Saint Petersburg, Russia
Local Institution - 506
Saint Petersburg, Russia
Local Institution - 508
Saratov, Russia
Local Institution - 502
Tula, Russia
Local Institution - 251
Busan, South Korea
Local Institution - 257
Daegu, South Korea
Local Institution - 250
Hwasun-Gun, South Korea
Local Institution - 253
Seongnam-si, South Korea
Local Institution - 252
Seoul, South Korea
Local Institution - 256
Seoul, South Korea
Local Institution - 255
Seoul, South Korea
Local Institution - 254
Seoul, South Korea
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
Málaga, Spain
Local Institution - 361
Murcia, Spain
Local Institution - 356
Ourense, Spain
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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
Gothenburg, Sweden
Local Institution - 552
Lund, Sweden
Local Institution - 551
Stockholm, Sweden
Local Institution - 450
Bern, Switzerland
Local Institution - 452
Lucerne, 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, Taiwan
Local Institution - 224
Taichung, Taiwan
Local Institution - 221
Taipei, Taiwan
Local Institution - 342
Ankara, Turkey (Türkiye)
Local Institution - 340
Manisa, Turkey (Türkiye)
Local Institution - 343
Trabzon, Turkey (Türkiye)
Local Institution - 526
Cherkassy, Ukraine
Local Institution - 525
Dnipro, Ukraine
Local Institution - 522
Kyiv, Ukraine
Local Institution - 520
Lviv, 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