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).

View Eligibility Criteria

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

Study is for people with:

Myelodysplastic Syndrome

Phase:

Phase 3

Estimated Enrollment:

363

Study ID:

NCT03682536

Recruitment Status:

Active, not recruiting

Sponsor:

Celgene

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There are 223 Locations for this study

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Local Institution - 107
Berkeley California, 94704, United States
Local Institution - 115
San Diego California, 92123, United States
Local Institution - 101
Whittier California, 90603, United States
Local Institution - 104
New Haven Connecticut, 06520, United States
Local Institution - 136
Washington District of Columbia, 20422, United States
Local Institution - 119
Hudson Florida, 34667, United States
Local Institution - 120
Saint Petersburg Florida, 33705, United States
Local Institution - 122
Tallahassee Florida, 32308, United States
Local Institution - 108
Tampa Florida, 33612, United States
Local Institution - 118
West Palm Beach Florida, 33401, United States
Local Institution - 102
Paducah Kentucky, 42003, United States
Local Institution - 123
Bethesda Maryland, 20817, United States
Local Institution - 117
Kansas City Missouri, 64132, United States
Local Institution - 134
East Brunswick New Jersey, 08816, United States
Local Institution - 113
Hackensack New Jersey, 07601, United States
Local Institution - 105
Greenville North Carolina, 27858, United States
Local Institution - 131
Portland Oregon, 97213, United States
Univ of Pittsburgh Medical Center
Pittsburgh Pennsylvania, 15232, United States
Local Institution - 111
Rock Hill South Carolina, 29732, United States
Tennessee Oncology
Nashville Tennessee, 37203, United States
Baylor University Medical Center
Dallas Texas, 75246, United States
Local Institution - 109
Houston Texas, 77030, United States
Utah Cancer Specialists - South Salt Lake
Salt Lake City Utah, 84106, United States
Local Institution - 132
Charlottesville Virginia, 22903, United States
Local Institution - 127
Chesapeake Virginia, 23320, United States
Local Institution - 206
Albury New South Wales, 2640, Australia
Local Institution - 213
Blacktown New South Wales, 2148, Australia
Local Institution - 200
Concord New South Wales, 2139, Australia
Local Institution - 215
Kogarah New South Wales, 2217, Australia
Local Institution - 211
Nowra New South Wales, 2541, Australia
Local Institution - 210
Waratah New South Wales, 2298, Australia
Local Institution - 207
Wollongong New South Wales, 2500, Australia
Local Institution - 208
Auchenflower Queensland, 4066, Australia
Local Institution - 202
Adelaide South Australia, 5000, Australia
Local Institution - 204
Clayton Victoria, 3168, Australia
Local Institution - 203
Malvern Victoria, 3144, Australia
Local Institution - 209
Melbourne Victoria, 3004, Australia
Local Institution - 205
West Perth Western Australia, 6005, Australia
Local Institution - 212
Randwick , 2031, Australia
Local Institution - 442
Linz , 4020, Austria
Local Institution - 441
Vienna , 1090, Austria
Local Institution - 475
Antwerpen , 2020, Belgium
Local Institution - 471
Brasschaat , 2930, Belgium
Local Institution - 474
Brussels , 1200, Belgium
Local Institution - 472
Charleroi , 6000, Belgium
Local Institution - 473
Kortrijk , 8500, Belgium
Local Institution - 470
Leuven , 3000, Belgium
Local Institution - 476
Roeselare , 8800, Belgium
Local Institution - 147
Calgary Alberta, T2N 4, Canada
Local Institution - 145
Edmonton Alberta, T6G 2, Canada
Local Institution - 142
Hamilton Ontario, L8V 5, Canada
Local Institution - 140
Ottawa Ontario, K1H 8, Canada
Local Institution - 141
Toronto Ontario, M4N 3, Canada
Local Institution - 144
Montreal Quebec, H1T 2, Canada
Local Institution - 148
Montreal Quebec, H3T 1, Canada
Local Institution - 151
Saskatoon Saskatchewan, S7N 4, Canada
Local Institution - 152
Sherbrooke , J1H 5, Canada
Local Institution - 560
Hradec Kralove , 500 0, Czechia
Local Institution - 564
Ostrava-Poruba , 708 5, Czechia
Local Institution - 563
Prague 10 , 100 3, Czechia
Local Institution - 562
Praha 2 , 128 0, Czechia
Local Institution - 561
Praha , 128 2, Czechia
Local Institution - 317
Angers , 49000, France
Local Institution - 312
Bayonne , 64109, France
Local Institution - 311
Caen Cedex 9 , 14033, France
Local Institution - 306
La Tronche , 38700, France
Local Institution - 305
Le Mans , 72037, France
Local Institution - 309
Lille , 59037, France
Local Institution - 303
Limoges Cedex , 87042, France
Local Institution - 307
Nantes Cedex 01 , 44093, France
Local Institution - 301
Nice Cedex 3 , 06200, France
Local Institution - 302
Paris , 75010, France
Local Institution - 313
Paris , 75014, France
Local Institution - 308
Pessac , 33604, France
Local Institution - 315
Pierre Bénite , 69495, France
Local Institution - 316
Poitiers , 86021, France
Local Institution - 314
Strasbourg , 67033, France
Local Institution - 300
Toulouse , 31059, France
Local Institution - 310
Tours cedex , 37044, France
Local Institution - 304
Vandoeuvre les Nancy , 54511, France
Local Institution - 422
Baden-Warttemberg , 73557, Germany
Local Institution - 424
Berlin , 14195, Germany
Local Institution - 426
Dresden , 01307, Germany
Local Institution - 429
Duisburg , 47166, Germany
Local Institution - 420
Dusseldorf , 40479, Germany
Local Institution - 431
Hamburg , 22081, Germany
Local Institution - 435
Keil , 24105, Germany
Local Institution - 423
Koblenz , 56068, Germany
Local Institution - 428
Köln , 50677, Germany
Local Institution - 430
Leipzig , 04103, Germany
Local Institution - 436
Mannheim , 68167, Germany
Local Institution - 421
Munchen , 81675, Germany
Local Institution - 425
Winnenden , 71364, Germany
Local Institution - 427
Würzburg , 97070, Germany
Local Institution - 389
Heraklion Irakleio, 71110, Greece
Local Institution - 396
Alexandroupolis , 08100, Greece
Local Institution - 397
Athens , 10676, Greece
Local Institution - 391
Athens , 115 2, Greece
Local Institution - 392
Athens , 12464, Greece
Local Institution - 395
Athina , 115 2, Greece
Local Institution - 398
Patras , 26500, Greece
Local Institution - 393
Rio Patras , 26500, Greece
Local Institution - 399
Thessaloniki , 546 3, Greece
Local Institution - 390
Thessaloniki , 57010, Greece
Local Institution - 535
Budapest , 1096, Hungary
Local Institution - 534
Debrecen , 4032, Hungary
Local Institution - 536
Nyiregyhaza , 4400, Hungary
Local Institution - 386
Haifa , 34362, Israel
Local Institution - 383
Jerusalem , 91031, Israel
Local Institution - 384
Jerusalem , 91120, Israel
Local Institution - 381
Kfar-Saba , 44281, Israel
Local Institution - 385
Nahariya , 22100, Israel
Local Institution - 382
Tel Aviv , 64239, Israel
Local Institution - 380
Zerifin , 70300, Israel
Local Institution - 331
Orbassano TO, 10043, Italy
Local Institution - 324
Bologna , 40138, Italy
Local Institution - 327
Firenze , 50134, Italy
Local Institution - 330
Meldola , 47014, Italy
Local Institution - 321
Milano , 20162, Italy
Local Institution - 329
Padova , 35128, Italy
Local Institution - 326
Reggio Di Calabria , 89124, Italy
Local Institution - 328
Roma , 00133, Italy
Local Institution - 332
Roma , 00189, Italy
Local Institution - 325
Rome , 00161, Italy
Local Institution - 323
Rozzano , 20089, Italy
Local Institution - 322
Udine , 33100, Italy
Local Institution - 238
Matsuyama Ehime, 790-8, Japan
Local Institution - 244
Nagasaki-shi Nagasaki, 852-8, Japan
Local Institution - 236
Osakasayama Osaka, 58985, Japan
Local Institution - 247
Amagasaki-Shi , 660-0, Japan
Local Institution - 249
Fujisawa-Shi , 251-0, Japan
Local Institution - 234
Fukuoka , 810-8, Japan
Local Institution - 237
Hitachi, Ibaraki , 317-0, Japan
Local Institution - 231
Kamogawa , 296-8, Japan
Local Institution - 248
Kitakyushu-Shi , 806-0, Japan
Local Institution - 270
Nagaoka-Shi , 940-2, Japan
Local Institution - 243
Nagoya-shi , 460-0, Japan
Local Institution - 241
Ogaki , 503-8, Japan
Local Institution - 235
Okayama , 700-8, Japan
Local Institution - 242
Osaka , 545-8, Japan
Local Institution - 233
Sagamihara , 252-0, Japan
Local Institution - 246
Sapporo-shi , 064-0, Japan
Local Institution - 239
Sendai , 980-8, Japan
Local Institution - 232
Shibuya-ku , 150-8, Japan
Local Institution - 245
Shimotsuga-gun , 321-0, Japan
Local Institution - 230
Shinagawa-ku, Tokyo , 141-8, Japan
Local Institution - 251
Busan , 49241, Korea, Republic of
Local Institution - 257
Daegu , 700-7, Korea, Republic of
Local Institution - 250
Hwasun-Gun , 58128, Korea, Republic of
Local Institution - 253
Seongnam-si , 13620, Korea, Republic of
Local Institution - 252
Seoul , 06351, Korea, Republic of
Local Institution - 256
Seoul , 06591, Korea, Republic of
Local Institution - 255
Seoul , 3080, Korea, Republic of
Local Institution - 254
Seoul , 5505, Korea, Republic of
Local Institution - 540
Kaunas , LT-50, Lithuania
Local Institution - 541
Vilnius , LT-08, Lithuania
Local Institution - 462
Amsterdam , 1081 , Netherlands
Local Institution - 461
Den Haag , 2545 , Netherlands
Local Institution - 464
Nijmegen , 6525 , Netherlands
Local Institution - 460
Rotterdam , 3015 , Netherlands
Local Institution - 463
Sittard-Geleen , 6162 , Netherlands
Local Institution - 570
Lodz Lódzkie, 93-51, Poland
Local Institution - 575
Gdansk , 80-95, Poland
Local Institution - 572
Lubin , 20-08, Poland
Local Institution - 576
Poznan , 60-56, Poland
Local Institution - 573
Rzwszow , 35-05, Poland
Local Institution - 579
Slupsk , 76-20, Poland
Local Institution - 578
Walbrzych , 58-30, Poland
Local Institution - 577
Wroclaw , 50-36, Poland
Local Institution - 571
Wroclaw , 50-55, Poland
Local Institution - 373
Beja , 7801-, Portugal
Local Institution - 371
Braga , 4710-, Portugal
Local Institution - 372
Lisboa , 1099-, Portugal
Local Institution - 370
Porto , 4200-, Portugal
Local Institution - 374
Setubal , 2910-, Portugal
Local Institution - 511
Kaluga , 24800, Russian Federation
Local Institution - 505
Kirov , 61002, Russian Federation
Local Institution - 509
Krasnoyarsk , 66002, Russian Federation
Local Institution - 504
Moscow , 11112, Russian Federation
Local Institution - 507
Moscow , 12318, Russian Federation
Local Institution - 500
Moscow , 12528, Russian Federation
Local Institution - 503
Moscow , 12930, Russian Federation
Local Institution - 508
Saratov , 41001, Russian Federation
Local Institution - 506
St Petersburg , 19734, Russian Federation
Local Institution - 510
St. Petersburg , 19702, Russian Federation
Local Institution - 502
Tula , 30005, Russian Federation
Local Institution - 358
Barcelona , 08035, Spain
Local Institution - 350
Barcelona , 08908, Spain
Local Institution - 354
Granada , 18014, Spain
Local Institution - 352
Madrid , 28007, Spain
Local Institution - 355
Madrid , 28041, Spain
Local Institution - 353
Malaga , 29010, Spain
Local Institution - 361
Murcia , 30008, Spain
Local Institution - 356
Ourense , 32005, Spain
Local Institution - 363
Oviedo , 33011, Spain
Local Institution - 362
Palma de Mallorca , 7120, Spain
Local Institution - 351
Salamanca , 37007, Spain
Local Institution - 360
Seville , 41013, Spain
Local Institution - 357
Valencia , 46010, Spain
Local Institution - 359
Valencia , 46026, Spain
Local Institution - 550
Goteborg , SE-41, Sweden
Local Institution - 552
Lund , SE-22, Sweden
Local Institution - 551
Stockholm , SE-14, Sweden
Local Institution - 450
Bern , 3010, Switzerland
Local Institution - 452
Luzern 16 , 6000, Switzerland
Local Institution - 451
Winterthur , 8400, Switzerland
Local Institution - 220
Changhua City, Changhua , 500, Taiwan
Local Institution - 222
Niaosong District Kaohsiung City , 83301, Taiwan
Local Institution - 223
Taichung City , 40447, Taiwan
Local Institution - 224
Taichung , 40705, Taiwan
Local Institution - 221
Taipei, Zhongzheng Dist. , 10002, Taiwan
Local Institution - 342
Ankara , 06100, Turkey
Local Institution - 340
Manisa , 45030, Turkey
Local Institution - 343
Trabzon , 61080, Turkey
Local Institution - 526
Cherkassy , 18009, Ukraine
Local Institution - 525
Dnipro , 49102, Ukraine
Local Institution - 522
Kyiv , 3115, Ukraine
Local Institution - 520
Lvov , 79044, Ukraine
Local Institution - 523
Mykolaiv , 54058, Ukraine
Local Institution - 521
Ternopil , 46002, Ukraine
Local Institution - 401
Aberdeen , AB25 , United Kingdom
Local Institution - 403
Bournemouth , BH7 7, United Kingdom
Local Institution - 405
Headington, Oxford , OX3 7, United Kingdom
Local Institution - 407
Lincoln , LN2 5, United Kingdom
Local Institution - 404
London , SE5 9, United Kingdom
Local Institution - 400
Manchester , M20 4, United Kingdom

How clear is this clinincal trial information?

Study is for people with:

Myelodysplastic Syndrome

Phase:

Phase 3

Estimated Enrollment:

363

Study ID:

NCT03682536

Recruitment Status:

Active, not recruiting

Sponsor:


Celgene

How clear is this clinincal trial information?

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