A Study to Evaluate Long-term Safety in Participants Who Have Participated in Other Luspatercept (ACE-536) Clinical Trials

PHASE3RecruitingINTERVENTIONAL
Enrollment

665

Participants

Timeline

Start Date

August 12, 2019

Primary Completion Date

May 12, 2028

Study Completion Date

May 12, 2028

Conditions
Myelodysplastic Syndromes (MDS)Beta-thalassemiaMyeloproliferative Neoplasm(MPN)-Associated Myelofibrosis
Interventions
DRUG

Luspatercept

Luspatercept (ACE-536), an erythroid maturation agent, is a recombinant fusion protein consisting of a modified form of the extracellular domain (ECD) of the human activin receptor type IIB (ActRIIB) linked to the human immunoglobin G 1 (IgG1) Fc domain. ActRIIB receptor and its ligands are members of the transforming growth factor-β (TGF-β) superfamily. Members of the TGF-β superfamily ligands, through their binding to activin receptors, are involved in modulating the differentiation of late-stage erythrocyte precursors (normoblasts) in the bone marrow. Luspatercept for injection is formulated as a sterile, preservative-free, lyophilized cake/powder. Luspatercept for injection is available in 25 mg and 75 mg vials and when reconstituted with water for injection, each consists of 50 mg/mL luspatercept in a 10 mM citrate buffer-based solution

Trial Locations (143)

133

COMPLETED

Local Institution - 465, Roma

807

COMPLETED

Local Institution - 760, Kaohsiung, San Ming Dist.

1006

RECRUITING

Bone Marrow Transplant Center, Tunis

1008

RECRUITING

Aziza Othmana Hospital, Tunis

RECRUITING

Military Hospital of Tunis, Tunis

1797

COMPLETED

Local Institution - 220, Boulevard

2050

RECRUITING

Royal Prince Alfred Hospital, Camperdown

2930

COMPLETED

Local Institution - 182, Brasschaat

3000

COMPLETED

Local Institution - 184, Leuven

3168

COMPLETED

Local Institution - 102, Clayton

4002

COMPLETED

Local Institution - 221, Plovdiv

4031

RECRUITING

University Hospital Farhat Hached, Sousse

4101

COMPLETED

Local Institution - 100, South Brisbane

5000

RECRUITING

Royal Adelaide Hospital, Adelaide

8000

COMPLETED

Local Institution - 180, Bruges

8035

COMPLETED

Local Institution - 685, Barcelona

9000

COMPLETED

Local Institution - 183, Ghent

10043

RECRUITING

Azienda Ospedaliero Universitaria S. Luigi Gonzaga, Orbassano

10065

COMPLETED

Local Institution - 969, New York

10330

RECRUITING

Chulalongkorn University Faculty of Medicine - King Chulalongkorn Memorial Hospital, Bangkok

10700

RECRUITING

Siriraj Hospital Mahidol University, Bangkok

11527

COMPLETED

Local Institution - 384, Athens

13385

COMPLETED

Local Institution - 301, Marseille

14195

COMPLETED

Local Institution - 341, Berlin

15100

COMPLETED

Local Institution - 470, Allessandria

16128

RECRUITING

Ente Ospedaliero Ospedali Galliera - Centro della Microcitemia e delle Anemie Congenite, Genoa

18341

COMPLETED

Local Institution - 425, Afula

19104

COMPLETED

Local Institution - 972, Philadelphia

20089

WITHDRAWN

Local Institution - 474, Rozzano

20122

RECRUITING

Maggiore Polyclinic Hospital, IRCCS Ca' Granda, Milan

21100

COMPLETED

Local Institution - 472, Varese

22081

COMPLETED

Local Institution - 342, Hamburg

22100

COMPLETED

Local Institution - 421, Nahariya

26500

COMPLETED

Local Institution - 383, Rio Patras

27100

COMPLETED

Local Institution - 469, Pavia

28028

COMPLETED

Local Institution - 687, Madrid

30625

COMPLETED

Local Institution - 344, Hanover

30990

RECRUITING

Hospital Raja Permaisuri Bainun, Ipoh

31059

COMPLETED

Local Institution - 309, Toulouse

33011

COMPLETED

Local Institution - 682, Oviedo

33343

COMPLETED

Local Institution - 883, Mersin

33604

WITHDRAWN

Local Institution - 307, Pessac

33612

COMPLETED

Local Institution - 975, Tampa

34093

COMPLETED

Local Institution - 882, Istanbul

34098

COMPLETED

Local Institution - 884, Istanbul

35100

COMPLETED

Local Institution - 880, Izmir

37007

COMPLETED

Local Institution - 684, Salamanca

37044

WITHDRAWN

Local Institution - 303, Tours

37134

COMPLETED

Local Institution - 463, Verona

38700

COMPLETED

Local Institution - 310, La Tronche

40138

COMPLETED

Local Institution - 464, Bologna

40225

COMPLETED

Local Institution - 345, Düsseldorf

40447

RECRUITING

China Medical University Hospital, Taichung

40479

COMPLETED

Local Institution - 346, Düsseldorf

41013

COMPLETED

Local Institution - 680, Seville

41124

COMPLETED

Local Institution - 479, Modena

44124

COMPLETED

Local Institution - 462, Ferrara

44195

ACTIVE_NOT_RECRUITING

Local Institution - 967, Cleveland

46026

COMPLETED

Local Institution - 683, Valencia

48201

COMPLETED

Local Institution - 961, Detroit

48903

COMPLETED

Local Institution - 681, Barakaldo

49033

COMPLETED

Local Institution - 305, Angers

49100

COMPLETED

Local Institution - 423, Petah Tikva

50134

ACTIVE_NOT_RECRUITING

Local Institution - 478, Florence

50139

ACTIVE_NOT_RECRUITING

Local Institution - 471, Florence

50200

RECRUITING

Chiang Mai University - Maharaj Nakorn Chiang Mai Hospital, Chiang Mai

54642

COMPLETED

Local Institution - 381, Thessaloniki

55131

COMPLETED

Local Institution - 340, Mainz

59037

COMPLETED

Local Institution - 306, Lille

59100

RECRUITING

University Malaya Medical Centre, Kuala Lumpur

60611

COMPLETED

Local Institution - 970, Chicago

67091

COMPLETED

Local Institution - 308, Strasbourg

69495

COMPLETED

Local Institution - 304, Pierre-Bénite

72100

COMPLETED

Local Institution - 466, Brindisi

73100

COMPLETED

Local Institution - 473, Lecce

75010

COMPLETED

Local Institution - 302, Paris

77030

WITHDRAWN

The University of Texas - MD Anderson Cancer Center, Houston

80100

COMPLETED

Local Institution - 545, Johor Bahru

80131

RECRUITING

AORN A Cardarelli, Napoli

RECRUITING

AOU dell'Universita degli Studi della Campania Luigi Vanvitelli, Napoli

81675

COMPLETED

Local Institution - 347, München

88586

RECRUITING

Queen Elizabeth Hospital, Kota Kinabalu

89124

COMPLETED

Local Institution - 468, Reggio Calabria

91031

COMPLETED

Local Institution - 422, Jerusalem

91120

COMPLETED

Local Institution - 424, Jerusalem

93586

RECRUITING

Hospital Umum Sarawak, Kuching

94010

COMPLETED

Local Institution - 300, Créteil

94305

COMPLETED

Local Institution - 978, Stanford

94609

COMPLETED

Local Institution - 971, Oakland

100225

COMPLETED

Local Institution - 761, Taipei

100730

WITHDRAWN

Local Institution - 131, Beijing

200233

WITHDRAWN

Local Institution - 132, Shanghai

300020

WITHDRAWN

Local Institution - 130, Tianjin

310009

WITHDRAWN

Local Institution - 133, Hangzhou

510515

WITHDRAWN

Local Institution - 135, Guangzhou

610041

WITHDRAWN

Local Institution - 134, Chengdu

3109601

RECRUITING

Rambam Health Corporation, Haifa

8528511

WITHDRAWN

Local Institution - 611, Nagasaki

90027-6062

RECRUITING

Childrens Hospital Los Angeles RHU, Los Angeles

02115

COMPLETED

Local Institution - 973, Boston

37232-5505

WITHDRAWN

Vanderbilt - Ingram Cancer Center, Nashville

M4N 3M5

COMPLETED

Local Institution - 262, Toronto

M5G 2C4

COMPLETED

Local Institution - 260, Toronto

M5G 2M9

COMPLETED

Local Institution - 263, Toronto

01307

COMPLETED

Local Institution - 348, Dresden

06120

COMPLETED

Local Institution - 343, Halle

04103

WITHDRAWN

Local Institution - 349, Leipzig

115 27

RECRUITING

Aghia Sophia' Children's General Hospital of Athens, Athens

RECRUITING

Laiko General Hospital of Athens - Center of Thalassemia, Athens

09121

COMPLETED

Local Institution - 477, Cagliari

460-0001

COMPLETED

Local Institution - 610, Nagoya

296-0041

COMPLETED

Local Institution - 601, Kamogawa

790-8524

RECRUITING

Matsuyama Red Cross Hospital, Matsuyama

503-8502

RECRUITING

Ogaki Municipal Hospital, Ōgaki

670-8540

RECRUITING

Japanese Red Cross Society Himeji Hospital, Himeji

317-0077

ACTIVE_NOT_RECRUITING

Local Institution - 605, Hitachi

252-0329

RECRUITING

Kitasato University Hospital, Sagamihara

980-8574

WITHDRAWN

Local Institution - 0979, Sendai

RECRUITING

Tohoku University Hospital, Sendai

150-8935

RECRUITING

Japanese Red Cross Medical Center, Shibuya City

141-8625

RECRUITING

NTT Medical Center Tokyo, Shinagawa City

260-0852

COMPLETED

Local Institution - 612, Chiba

247-8533

RECRUITING

Shonan Kamakura General Hospital, Kamakura

545-8586

RECRUITING

Osaka Metropolitan University Hospital, Osaka

589-8511

ACTIVE_NOT_RECRUITING

Local Institution - 604, Osaka

00961

RECRUITING

Chronic Care Center, Hazmiyeh

05460

RECRUITING

Hospital Sultanah Bahiyah, Alor Star

1081 HV

COMPLETED

Local Institution - 580, Amsterdam

08908

COMPLETED

Local Institution - 686, Barcelona

413 45

COMPLETED

Local Institution - 720, Gothenburg

SE-221 85

COMPLETED

Local Institution - 722, Lund

141 86

COMPLETED

Local Institution - 721, Stockholm

01130

RECRUITING

Acibadem Adana Hospital, Adana

06590

COMPLETED

Local Institution - 885, Ankara

AB25 2ZN

COMPLETED

Local Institution - 925, Aberdeen

LS9 7TF

WITHDRAWN

Local Institution - 921, Leeds

E1 1BB

COMPLETED

Local Institution - 923, London

N19 5NF

RECRUITING

Whittington Hospital, London

NW1 2BU

RECRUITING

University College London Hospitals NHS Foundation Trust - University College Hospital, London

SE1 9RT

COMPLETED

Local Institution - 928, London

SE5 9RS

COMPLETED

Local Institution - 924, London

OX3 7LE

WITHDRAWN

Local Institution - 929, Oxford

NG17 4JL

WITHDRAWN

Local Institution - 926, Sutton in Ashfield

Sponsors

Lead Sponsor

All Listed Sponsors
lead

Celgene

INDUSTRY