An Efficacy and Safety Study of Luspatercept (ACE-536) Versus Placebo in Subjects With Myeloproliferative Neoplasm-Associated Myelofibrosis on Concomitant JAK2 Inhibitor Therapy and Who Require Red Blood Cell Transfusions

PHASE3Active, not recruitingINTERVENTIONAL
Enrollment

313

Participants

Timeline

Start Date

February 25, 2021

Primary Completion Date

May 26, 2025

Study Completion Date

August 18, 2032

Conditions
Myeloproliferative DisordersMyelofibrosisPrimary MyelofibrosisPost-Polycythemia Vera MyelofibrosisAnemia
Interventions
DRUG

ACE-536

Subcutaneous Injection

OTHER

Placebo

Subcutaneous Injection

Trial Locations (185)

0

Local Institution - 821, Qingdao

Local Institution - 810, Zhengzhou

Local Institution - 661, Hong Kong

Prince of Wales Hospital the Chinese University of Hong Kong, Shatin

7

Mater Misercordiae Hospital, Dublin

144

Local Institution - 249, Roma

652

Local Institution - 551, Saida

1090

Local Institution - 271, Vienna

1096

Local Institution - 462, Budapest

1140

Local Institution - 274, Vienna

1200

Local Institution - 312, Brussels

2250

Gosford Hospital, Gosford

3000

Uz Leuven, Leuven

3004

The Alfred Hospital, Melbourne

3080

Seoul National University Hospital, Seoul

3168

Monash Medical Centre, Clayton

3500

Local Institution - 313, Hasselt

4000

Local Institution - 319, Liège

4020

Krankenhaus der Elisabethinen Linz, I Interne Abteilung, Linz

4800

Local Institution - 315, Verviers

5505

Asan Medical Center, Seoul

5530

Cliniques Universitaires UCL de Mont-Godine, Yvoir

6009

Sir Charles Gairdner Hospital, Nedlands

7000

Royal Hobart Hospital, Hobart

7120

Local Institution - 202, Palma de Mallorca

8000

Local Institution - 318, Bruges

8036

Local Institution - 272, Graz

8800

Local Institution - 316, Roeselare

9023

Local Institution - 463, Győr

10029

Mount Sinai Medical Center, New York

10126

Local Institution - 259, Torino

10676

Evangelismos General Hospital of Athens, Athens

12464

Attikon University General Hospital, Athens

13620

Local Institution - 643, Seongnam-si

15213

University of Pittsburg Medical Center, Pittsburgh

15224

Allegheny Health Network, Pittsburgh

15706

Complejo Hospitalario Universitario De Santiago, Santiago de Compostela

18014

Local Institution - 208, Granada

20122

Fondazione Irccs Ca' Granda Ospedale Maggiore Policlinico, Milan

21100

Universita degli Studi dell'Insubria - Ospedale di Circolo e Fondazione Macchi - Varese, Varese

22081

Local Institution - 300, Hamburg

25123

Asst Spedali Civili Di Brescia, Brescia

26500

University General Hospital of Patras, Rio Patras

28034

Hospital Universitario Ramón y Cajal, Madrid

28041

Hospital Universitario 12 De Octubre, Madrid

28100

A.O.U. Maggiore della Carit, Novara

30029

Centre Hospitalier Universitaire de Nimes (CHU) - Hopital Universitaire Caremeau, Nîmes

31059

Local Institution - 330, Toulouse

31096

Rambam Medical Center, Haifa

32429

Johannes Wiesling Klinikum Minden, Minden

32804

Local Institution - 135, Orlando

33322

Local Institution - 133, Plantation

33604

Groupe Hospitalier Sud Hopital Haut Leveque USN, Pessac

35012

Hospital Universitario De Gran Canaria Dr. Negrin, Las Palmas de Gran Canaria

35128

Azienda Ospedaliera Di Padova, Padua

37007

Universitario de Salamanca - Hospital Clinico, Salamanca

37134

Centro Ricerche Cliniche di Verona S.r.l., Verona

37920

Local Institution - 130, Knoxville

38043

Chu De Grenoble, Grenoble

40138

Azienda Ospedaliero-Universitaria di Bologna - Policlinico S.Orsola-Malpighi, Bologna

40225

Local Institution - 299, Düsseldorf

41013

Hospital Universitario Virgen del Rocio, Seville

44281

Meir Medical Center, Kfar Saba

46010

Hospital Clinico Universitario De Valencia, Valencia

47014

"IRCCS - Istituto Romagnolo per lo Studio Dei Tumori Dino Amadori (IRST)", Meldola (fc)

48109

Local Institution - 114, Ann Arbor

49033

Local Institution - 331, Angers

50034

Local Institution - 161, Medellín

50134

Azienda Ospedaliera Universitaria Careggi, Florence

50367

Local Institution - 435, Wroclaw

52074

Unviversitatsklinikum Aachen, Aachen

56100

Local Institution - 248, Pisa

57010

Georgios Papanikolaou General Hospital of Thessaloniki, Thessaloniki

58128

Chonnam National University Hwasun Hospital, Hwasun-Gun

59037

Local Institution - 327, Lille

60126

Local Institution - 250, Ancona

60612

Local Institution - 112, Chicago

63000

Local Institution - 333, Clermont-Ferrand

63110

Local Institution - 108, St Louis

64239

Tel-Aviv Sourasky Medical Center, Tel Aviv

67200

ICANS Institut de cancerologie Strasbourg Europe, Strasbourg

68167

Local Institution - 301, Mannheim

69008

Local Institution - 332, Lyon

70300

Shamir Medical Center - Assaf Harofeh, Ẕerifin

73557

Stauferklinikum Schwab. Gmund, Baden-Warttemberg

75475

Hopital Saint Louis, Paris

77030

The University of Texas - MD Anderson Cancer Center, Houston

80131

Local Institution - 246, Napoli Campania

84112

Local Institution - 119, Salt Lake City

86021

CHU La Miletrie, Poitiers

89124

Grande Ospedale Metropolitano Bianchi-Melacrino-Morelli, Reggio Calabria

90095

Local Institution - 110, Los Angeles

91120

Hadassah Medical Organization, Jerusalem

94010

Local Institution - 324, Créteil

95123

Azienda Ospedaliero - Universitaria Policlinico - Vittorio Emanuele - Ospedale Gaspare Rodolico, Catania

100730

Beijing Peking Union Medical College Hospital, Beijing

111511

Local Institution - 163, Bogotá

125284

Local Institution - 500, Moscow

130021

Local Institution - 802, Changchun

150081

The First Affiliated Hospital Of Harbin Medical University, Harbin

197022

Local Institution - 503, Saint Petersburg

197341

Local Institution - 502, Saint Petersburg

200025

Local Institution - 809, Shanghai

200143

Local Institution - 395, Craiova

200233

Local Institution - 801, Shanghai

210029

Local Institution - 804, Nanjing

215006

Local Institution - 811, Suzhou

226001

Local Institution - 818, Nantong

300041

Local Institution - 800, Tianjin

300052

Tianjin Medical University General Hospital, Tianjin

330006

Local Institution - 820, Nanchang

330008

Nanchang University - The Second Affiliated Hospital, Nanchang

400015

Prof. Dr. I. Chiricuta Institute of Oncology, Cluj-Napoca

410008

Xiangya Hospital Central-South University, Changsha

500052

Onco Card SRL, Brasov

510030

Guangdong General Hospital, Guangzhou

510515

Nanfang Hospital of Southern Medical University, Guangzhou

650101

The Second Affiliated Hospital Of Kunming Medical University, Kunming

681002

Local Institution - 162, Floridablanca

1720430

IC La Serena Research, La Serena

5898511

Kindai University Hospital- Osakasayama Campus, Sayama

7500587

Local Institution - 193, Santiago

7560742

Local Institution - 192, Las Condes

8528511

The Japanese Red Cross Nagasaki Genbaku Hospital, Nagasaki

11072280

Local Institution - 550, Badaro Beirut

40536-0293

Local Institution - 124, Lexington

07601-2191

John Theurer Cancer Center, Hackensack

C1280AEB

Local Institution - 172, Ciudad Autónoma de BuenosAires

B1900AX

Hospital Italiano de La Plata, La Plata

C1199ABB

Hospital Italiano de Buenos Aires, Buenos Aires

T2N 4N2

Local Institution - 181, Calgary

T6G 2S2

Local Institution - 179, Edmonton

V6Z 2A5

Local Institution - 183, Vancouver

N6C 6B5

University Hospital - London Health Sciences Centre, London

M5G 2M9

Local Institution - 180, Toronto

H1T 2M4

Local Institution - 177, Montreal

H3T 1E2

Sir Mortimer B. Davis - Jewish Genl, Montreal

J1H5N4

Local Institution - 176, Sherbrooke

Unknown

The First Affiliated Hospital of Nanyang Medical College, Nanyang

030001

Local Institution - 816, Taiyuan

128 08

Local Institution - 341, Prague

06202

CHU de Nice Archet I, Nice

06120

Universitatsklinikum Halle Saale, Halle

07740

Universitaetsklinikum Jena, Jena

04103

Local Institution - 297, Leipzig

264 43

Local Institution - 387, Pátrai

08100

Local Institution - 383, Alexandroupoli

11 527

Local Institution - 386, Athens

T12 DFK4

Cork University Hospital, Cork

Dublin 8

St James Hospital, Dublin

00100

Azienda Policlinico Universitario Umberto I, Roma

00189

Local Institution - 251, Roma

05100

Local Institution - 245, Terni

113-8431

Local Institution - 701, Bunkyo-ku

409-3898

Local Institution - 709, Chūō

030-8553

Aomori Prefectural Central Hospital, Aomori

113-8677

Local Institution - 713, Bunkyō City

259-1193

Tokai University Hospital, Isehara City, Kanagawa

247-8533

Local Institution - 717, Kamakura

296-8602

Kameda General Hospital, Kamogawa

371-8511

Local Institution - 706, Maebashi

889-1692

University of Miyazaki Hospital, Miyazaki

545-8586

Osaka Metropolitan university Hospital, Osaka

503-8502

Ogaki Municipal Hospital, Ōgaki

003-0006

Local Institution - 708, Sapporo

141-8625

NTT Medical Center Tokyo, Shinagawa-ku, Tokyo

162-8666

Tokyo Women's Medical University Hospital, Shinjuku

160-0023

Local Institution - 710, Shinjyuku-ku

441-8570

Toyohashi Municipal Hospital, Toyohashi

11-3288

Local Institution - 552, Beirut

80-952

Local Institution - 436, Gdansk

31-501

Samodzielny Publiczny Zaklad Opieki Zdrowotnej Szpital Uniwersytecki w Krakowie, Krakow

93-510

Wojewódzki Szpital Specjalistyczny im. M. Kopernika w Lodzi, Lodz

61-696

Local Institution - 433, Poznan

58-309

Specjalistyczny Szpital im. dra Alfreda Sokolowskiego, Wałbrzych

022328

Local Institution - 391, Bucharest

700-721

Kyungpook National University Hospital, Daegu

06351

Local Institution - 647, Seoul

06591

The Catholic University of Korea Seoul - Saint Mary's Hospital, Seoul

08036

Hospital Clinic de Barcelona, Barcelona

08916

Hospital Universitari Germans Trias i Pujol ICO Badalona, Barcelona

NG5 1PB

Nottingham City Hospital, Nottingham

B9 5SS

Heart of England NHS Foundation Trust, Birmingham

PE21 9QS

United Lincolnshire Hospitals NHS Trust, Boston

OX3 7LI

Churchhill Hospital, Oxford

Sponsors

Lead Sponsor

All Listed Sponsors
lead

Celgene

INDUSTRY