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

PHASE3Active, not recruitingINTERVENTIONAL
Enrollment

363

Participants

Timeline

Start Date

January 2, 2019

Primary Completion Date

March 31, 2023

Study Completion Date

September 28, 2027

Conditions
Myelodysplastic Syndromes
Interventions
DRUG

Luspatercept

Specified dose on specified days

DRUG

Epoetin alfa

Specified dose on specified days

Trial Locations (226)

500

Local Institution - 220, Changhua City, Changhua

1090

Local Institution - 441, Vienna

1096

Local Institution - 535, Budapest

1200

Local Institution - 474, Brussels

2020

Local Institution - 475, Antwerp

2031

Local Institution - 212, Randwick

2139

Local Institution - 200, Concord

2148

Local Institution - 213, Blacktown

2217

Local Institution - 215, Kogarah

2298

Local Institution - 210, Waratah

2500

Local Institution - 207, Wollongong

2541

Local Institution - 211, Nowra

2640

Local Institution - 206, Albury

2930

Local Institution - 471, Brasschaat

3000

Local Institution - 470, Leuven

3004

Local Institution - 209, Melbourne

3010

Local Institution - 450, Bern

3080

Local Institution - 255, Seoul

3115

Local Institution - 522, Kyiv

3144

Local Institution - 203, Malvern

3168

Local Institution - 204, Clayton

4020

Local Institution - 442, Linz

4032

Local Institution - 534, Debrecen

4066

Local Institution - 208, Auchenflower

4400

Local Institution - 536, Nyíregyháza

5000

Local Institution - 202, Adelaide

5505

Local Institution - 254, Seoul

6000

Local Institution - 472, Charleroi

Local Institution - 452, Lucerne

6005

Local Institution - 205, West Perth

7120

Local Institution - 362, Palma de Mallorca

8400

Local Institution - 451, Winterthur

8500

Local Institution - 473, Kortrijk

8800

Local Institution - 476, Roeselare

10043

Local Institution - 331, Orbassano

10676

Local Institution - 397, Athens

12464

Local Institution - 392, Athens

13620

Local Institution - 253, Seongnam-si

14033

Local Institution - 311, Caen

14195

Local Institution - 424, Berlin

15232

Univ of Pittsburgh Medical Center, Pittsburgh

18009

Local Institution - 526, Cherkassy

18014

Local Institution - 354, Granada

20089

Local Institution - 323, Rozzano

20162

Local Institution - 321, Milan

20422

Local Institution - 136, Washington D.C.

20817

Local Institution - 123, Bethesda

22081

Local Institution - 431, Hamburg

22100

Local Institution - 385, Nahariya

22903

Local Institution - 132, Charlottesville

23320

Local Institution - 127, Chesapeake

24105

Local Institution - 435, Keil

26500

Local Institution - 398, Pátrai

Local Institution - 393, Rio Patras

28007

Local Institution - 352, Madrid

28041

Local Institution - 355, Madrid

29010

Local Institution - 353, Málaga

29732

Local Institution - 111, Rock Hill

30008

Local Institution - 361, Murcia

31059

Local Institution - 300, Toulouse

32005

Local Institution - 356, Ourense

32308

Local Institution - 122, Tallahassee

33011

Local Institution - 363, Oviedo

33100

Local Institution - 322, Udine

33401

Local Institution - 118, West Palm Beach

33604

Local Institution - 308, Pessac

33612

Local Institution - 108, Tampa

33705

Local Institution - 120, St. Petersburg

34362

Local Institution - 386, Haifa

34667

Local Institution - 119, Hudson

35128

Local Institution - 329, Padua

37007

Local Institution - 351, Salamanca

37044

Local Institution - 310, Tours

38700

Local Institution - 306, La Tronche

40138

Local Institution - 324, Bologna

40447

Local Institution - 223, Taichung

40479

Local Institution - 420, Düsseldorf

40705

Local Institution - 224, Taichung

41013

Local Institution - 360, Seville

42003

Local Institution - 102, Paducah

44093

Local Institution - 307, Nantes

44281

Local Institution - 381, Kfar Saba

45030

Local Institution - 340, Manisa

46002

Local Institution - 521, Ternopil

46010

Local Institution - 357, Valencia

46026

Local Institution - 359, Valencia

47014

Local Institution - 330, Meldola

47166

Local Institution - 429, Duisburg

49000

Local Institution - 317, Angers

49102

Local Institution - 525, Dnipro

49241

Local Institution - 251, Busan

50134

Local Institution - 327, Florence

50677

Local Institution - 428, Cologne

54058

Local Institution - 523, Mykolaiv

54511

Local Institution - 304, Vandœuvre-lès-Nancy

56068

Local Institution - 423, Koblenz

57010

Local Institution - 390, Thessaloniki

58128

Local Institution - 250, Hwasun-Gun

59037

Local Institution - 309, Lille

61080

Local Institution - 343, Trabzon

64109

Local Institution - 312, Bayonne

64132

Local Institution - 117, Kansas City

64239

Local Institution - 382, Tel Aviv

67033

Local Institution - 314, Strasbourg

68167

Local Institution - 436, Mannheim

69495

Local Institution - 315, Pierre-Bénite

70300

Local Institution - 380, Ẕerifin

71110

Local Institution - 389, Heraklion

71364

Local Institution - 425, Winnenden

72037

Local Institution - 305, Le Mans

73557

Local Institution - 422, Baden-Warttemberg

75010

Local Institution - 302, Paris

75014

Local Institution - 313, Paris

75246

Baylor University Medical Center, Dallas

77030

Local Institution - 109, Houston

79044

Local Institution - 520, Lviv

81675

Local Institution - 421, München

83301

Local Institution - 222, Niaosong District Kaohsiung City

84106

Local Institution - 114, Salt Lake City

86021

Local Institution - 316, Poitiers

87042

Local Institution - 303, Limoges

89124

Local Institution - 326, Reggio Calabria

90603

Local Institution - 101, Whittier

91120

Local Institution - 384, Jerusalem

92123

Local Institution - 115, San Diego

94704

Local Institution - 107, Berkeley

97070

Local Institution - 427, Würzburg

97213

Local Institution - 131, Portland

100225

Local Institution - 221, Taipei

111123

Local Institution - 504, Moscow

123182

Local Institution - 507, Moscow

125284

Local Institution - 500, Moscow

129301

Local Institution - 503, Moscow

197022

Local Institution - 510, Saint Petersburg

197341

Local Institution - 506, Saint Petersburg

248007

Local Institution - 511, Kaluga

300053

Local Institution - 502, Tula

410012

Local Institution - 508, Saratov

610027

Local Institution - 505, Kirov

660022

Local Institution - 509, Krasnoyarsk

5898511

Local Institution - 236, Sayama

8528511

Local Institution - 244, Nagasaki

9103102

Local Institution - 383, Jerusalem

06520

Local Institution - 104, New Haven

08816

Local Institution - 134, East Brunswick

07601

Local Institution - 113, Hackensack

27858-4354

Local Institution - 105, Greenville

37203-1625

Tennessee Oncology, Nashville

T2N 4N2

Local Institution - 147, Calgary

T6G 2B7

Local Institution - 145, Edmonton

L8V 5C2

Local Institution - 142, Hamilton

K1H 8L6

Local Institution - 140, Ottawa

M4N 3M5

Local Institution - 141, Toronto

H1T 2M4

Local Institution - 144, Montreal

H3T 1E2

Local Institution - 148, Montreal

S7N 4H4

Local Institution - 151, Saskatoon

J1H 5N4

Local Institution - 152, Sherbrooke

500 05

Local Institution - 560, Hradec Králové

708 52

Local Institution - 564, Ostrava-Poruba

100 34

Local Institution - 563, Prague

128 08

Local Institution - 562, Prague

128 20

Local Institution - 561, Prague

06200

Local Institution - 301, Nice

01307

Local Institution - 426, Dresden

04103

Local Institution - 430, Leipzig

08100

Local Institution - 396, Alexandroupoli

115 27

Local Institution - 391, Athens

Local Institution - 395, Athens

546 36

Local Institution - 399, Thessaloniki

00133

Local Institution - 328, Roma

00189

Local Institution - 332, Roma

00161

Local Institution - 325, Rome

790-8524

Local Institution - 238, Matsuyama

660-0892

Local Institution - 247, Amagasaki-Shi

251-0052

Local Institution - 249, Fujisawa-Shi

810-8563

Local Institution - 234, Fukuoka

317-0077

Local Institution - 237, Hitachi, Ibaraki

296-8602

Local Institution - 231, Kamogawa

806-0034

Local Institution - 248, Kitakyushu-Shi

940-2108

Local Institution - 270, Nagaoka-Shi

460-0001

Local Institution - 243, Nagoya

700-8557

Local Institution - 235, Okayama

545-8586

Local Institution - 242, Osaka

503-8502

Local Institution - 241, Ōgaki

252-0375

Local Institution - 233, Sagamihara

064-0804

Local Institution - 246, Sapporo

980-8574

Local Institution - 239, Sendai

150-8935

Local Institution - 232, Shibuya-ku

321-0293

Local Institution - 245, Shimotsuga-gun

141-8625

Local Institution - 230, Shinagawa-ku, Tokyo

LT-50009

Local Institution - 540, Kaunas

LT-08661

Local Institution - 541, Vilnius

1081 HV

Local Institution - 462, Amsterdam

6525 GA

Local Institution - 464, Nijmegen

3015 CE

Local Institution - 460, Rotterdam

6162 BG

Local Institution - 463, Sittard-Geleen

2545 CH

Local Institution - 461, The Hague

93-513

Local Institution - 570, Lodz

80-952

Local Institution - 575, Gdansk

20-081

Local Institution - 572, Lubin

60-569

Local Institution - 576, Poznan

35-055

Local Institution - 573, Rzwszow

76-200

Local Institution - 579, Słupsk

58-309

Local Institution - 578, Wałbrzych

50-367

Local Institution - 577, Wroclaw

50-556

Local Institution - 571, Wroclaw

7801-849

Local Institution - 373, Beja

4710-243

Local Institution - 371, Braga

1099-023

Local Institution - 372, Lisbon

4200-072

Local Institution - 370, Porto

2910-446

Local Institution - 374, Setúbal

700-721

Local Institution - 257, Daegu

06351

Local Institution - 252, Seoul

06591

Local Institution - 256, Seoul

08035

Local Institution - 358, Barcelona

08908

Local Institution - 350, Barcelona

SE-413 45

Local Institution - 550, Gothenburg

SE-221 85

Local Institution - 552, Lund

SE-141 86

Local Institution - 551, Stockholm

06100

Local Institution - 342, Ankara

AB25 2ZN

Local Institution - 401, Aberdeen

BH7 7DW

Local Institution - 403, Bournemouth

OX3 7LE

Local Institution - 405, Headington, Oxford

LN2 5QY

Local Institution - 407, Lincoln

SE5 9RS

Local Institution - 404, London

M20 4BX

Local Institution - 400, Manchester

Sponsors

Lead Sponsor

All Listed Sponsors
collaborator

Acceleron Pharma, Inc., a wholly-owned subsidiary of Merck & Co., Inc., Rahway, NJ USA

INDUSTRY

lead

Celgene

INDUSTRY

NCT03682536 - 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 | Biotech Hunter | Biotech Hunter