Actively Recruiting
Led by Celgene · Updated on 2026-05-28
665
Participants Needed
143
Research Sites
N/A
Total Duration
Researchers are evaluating the long-term safety of luspatercept in participants who have previously taken part in other luspatercept clinical trials. This open-label, single-arm Phase 3b rollover study includes participants receiving luspatercept or who are in post-treatment follow-up from parent protocols. The study aims to monitor adverse events, progression to higher-risk myelodysplastic syndromes or acute myeloid leukemia, and the development of other malignancies over an extended period. Participants receive luspatercept as a subcutaneous injection given by study staff at clinical sites. The study includes a Transition Phase with one enrollment visit, followed by either a Treatment Phase where participants continue the same dose and schedule from their parent trial, or a Long-term Post-treatment Follow-up Phase. The Follow-up Phase includes a 42-day safety follow-up after the last dose and ongoing monitoring every six months for at least five years from the first dose or three years after the last dose, whichever is later. During the study, participants undergo safety assessments and adverse event reporting, including monitoring for progression to serious blood disorders and new malignancies. Researchers track overall survival and the occurrence of treatment-related conditions such as extramedullary hematopoiesis masses. The study continues until participants complete five years of treatment and follow-up or withdraw. The long-term nature of the study supports thorough safety evaluation in this patient population.
CONDITIONS
A Study to Evaluate Long-term Safety in Participants Who Have Participated in Other Luspatercept (ACE-536) Clinical Trials
You may qualify if you...
You will not qualify if you...
Complete this quick 3-step screening to check your eligibility
Duration - 2 to 4 weeks
Participants are screened for eligibility to participate in the trial.
1 visit (in-person)
Duration - Duration depends on individual participant's continuation from parent protocol
Participants receive luspatercept as a subcutaneous injection administered by study staff at the clinical site.
Visits for luspatercept administration and safety monitoring as scheduled by the clinical site
Duration - Approximately 5 years
Participants are monitored for long-term safety including adverse events and progression to malignancies.
Periodic visits for long-term safety assessments
Total: 143 locations
1
Local Institution - 968
Los Angeles, California, United States, 90027-6062
Completed
2
Local Institution - 971
Oakland, California, United States, 94609
Completed
3
Local Institution - 978
Stanford, California, United States, 94305
Completed
4
Local Institution - 975
Tampa, Florida, United States, 33612
Completed
5
Local Institution - 970
Chicago, Illinois, United States, 60611
Completed
6
Local Institution - 973
Boston, Massachusetts, United States, 02115
Completed
7
Local Institution - 961
Detroit, Michigan, United States, 48201
Completed
8
Local Institution - 969
New York, New York, United States, 10065
Completed
9
Local Institution - 967
Cleveland, Ohio, United States, 44195
Completed
10
Local Institution - 972
Philadelphia, Pennsylvania, United States, 19104
Completed
11
Vanderbilt - Ingram Cancer Center
Nashville, Tennessee, United States, 37232-5505
Withdrawn
12
The University of Texas - MD Anderson Cancer Center
Houston, Texas, United States, 77030
Withdrawn
13
Local Institution - 100
South Brisbane, Queensland, Australia, 4101
Completed
14
Royal Adelaide Hospital
Adelaide, South Australia, Australia, 5000
Actively Recruiting
15
Local Institution - 102
Clayton, Victoria, Australia, 3168
Completed
16
Royal Prince Alfred Hospital
Camperdown, Australia, 2050
Actively Recruiting
17
Local Institution - 182
Brasschaat, Belgium, 2930
Completed
18
Local Institution - 180
Bruges, Belgium, 8000
Completed
19
Local Institution - 183
Ghent, Belgium, 9000
Completed
20
Local Institution - 184
Leuven, Belgium, 3000
Completed
21
Local Institution - 220
Boulevard, Sofia, Bulgaria, 1797
Completed
22
Local Institution - 221
Plovdiv, Bulgaria, 4002
Completed
23
Local Institution - 262
Toronto, Ontario, Canada, M4N 3M5
Completed
24
Local Institution - 260
Toronto, Ontario, Canada, M5G 2C4
Completed
25
Local Institution - 263
Toronto, Ontario, Canada, M5G 2M9
Completed
26
Local Institution - 131
Beijing, Beijing Municipality, China, 100730
Withdrawn
27
Local Institution - 135
Guangzhou, Guangdong, China, 510515
Withdrawn
28
Local Institution - 132
Shanghai, Shanghai Municipality, China, 200233
Withdrawn
29
Local Institution - 134
Chengdu, Sichuan, China, 610041
Withdrawn
30
Local Institution - 130
Tianjin, Tianjin Municipality, China, 300020
Withdrawn
31
Local Institution - 133
Hangzhou, Zhejiang, China, 310009
Withdrawn
32
Local Institution - 305
Angers, France, 49033
Completed
33
Local Institution - 300
Créteil, France, 94010
Completed
34
Local Institution - 310
La Tronche, France, 38700
Completed
35
Local Institution - 306
Lille, France, 59037
Completed
36
Local Institution - 301
Marseille, France, 13385
Completed
37
Local Institution - 302
Paris, France, 75010
Completed
38
Local Institution - 307
Pessac, France, 33604
Withdrawn
39
Local Institution - 304
Pierre-Bénite, France, 69495
Completed
40
Local Institution - 308
Strasbourg, France, 67091
Completed
41
Local Institution - 309
Toulouse, France, 31059
Completed
42
Local Institution - 303
Tours, France, 37044
Withdrawn
43
Local Institution - 341
Berlin, Germany, 14195
Completed
44
Local Institution - 348
Dresden, Germany, 01307
Completed
45
Local Institution - 345
Düsseldorf, Germany, 40225
Completed
46
Local Institution - 346
Düsseldorf, Germany, 40479
Completed
47
Local Institution - 343
Halle, Germany, 06120
Completed
48
Local Institution - 342
Hamburg, Germany, 22081
Completed
49
Local Institution - 344
Hanover, Germany, 30625
Completed
50
Local Institution - 349
Leipzig, Germany, 04103
Withdrawn
51
Local Institution - 340
Mainz, Germany, 55131
Completed
52
Local Institution - 347
München, Germany, 81675
Completed
53
Aghia Sophia' Children's General Hospital of Athens
Athens, Greece, 115 27
Actively Recruiting
54
Local Institution - 380
Athens, Greece, 115 27
Completed
55
Local Institution - 384
Athens, Greece, 11527
Completed
56
Local Institution - 383
Rio Patras, Greece, 26500
Completed
57
Local Institution - 381
Thessaloniki, Greece, 54642
Completed
58
Local Institution - 425
Afula, Israel, 1834111
Completed
59
Local Institution - 420
Haifa, Israel, 3109601
Completed
60
Local Institution - 422
Jerusalem, Israel, 91031
Completed
61
Local Institution - 424
Jerusalem, Israel, 91120
Completed
62
Local Institution - 421
Nahariya, Israel, 22100
Completed
63
Local Institution - 423
Petah Tikva, Israel, 49100
Completed
64
Local Institution - 478
Florence, Tuscany, Italy, 50134
Completed
65
Local Institution - 471
Florence, Tuscany, Italy, 50139
Active, Not Recruiting
66
Local Institution - 470
Allessandria, Italy, 15100
Completed
67
Local Institution - 464
Bologna, Italy, 40138
Completed
68
Local Institution - 466
Brindisi, Italy, 72100
Completed
69
Local Institution - 477
Cagliari, Italy, 09121
Completed
70
Local Institution - 462
Ferrara, Italy, 44124
Completed
71
Ente Ospedaliero Ospedali Galliera - Centro della Microcitemia e delle Anemie Congenite
Genoa, Italy, 16128
Actively Recruiting
72
Local Institution - 473
Lecce, Italy, 73100
Completed
73
Maggiore Polyclinic Hospital, IRCCS Ca' Granda
Milan, Italy, 20122
Actively Recruiting
74
Local Institution - 479
Modena, Italy, 41124
Completed
75
AORN A Cardarelli
Naples, Italy, 80131
Actively Recruiting
76
AOU dell'Universita degli Studi della Campania Luigi Vanvitelli
Naples, Italy, 80131
Actively Recruiting
77
Azienda Ospedaliero Universitaria S. Luigi Gonzaga
Orbassano, Italy, 10043
Actively Recruiting
78
Local Institution - 469
Pavia, Italy, 27100
Completed
79
Local Institution - 468
Reggio Calabria, Italy, 89124
Completed
80
Local Institution - 465
Roma, Italy, 133
Completed
81
Local Institution - 474
Rozzano, Italy, 20089
Withdrawn
82
Local Institution - 472
Varese, Italy, 21100
Completed
83
Local Institution - 463
Verona, Italy, 37134
Completed
84
Local Institution - 610
Nagoya, Aichi-ken, Japan, 460-0001
Completed
85
Local Institution - 601
Kamogawa, Chiba, Japan, 296-0041
Completed
86
Matsuyama Red Cross Hospital
Matsuyama, Ehime, Japan, 790-8524
Actively Recruiting
87
Ogaki Municipal Hospital
Ōgaki, Gifu, Japan, 503-8502
Actively Recruiting
88
Japanese Red Cross Society Himeji Hospital
Himeji, Hyōgo, Japan, 6708540
Actively Recruiting
89
Local Institution - 605
Hitachi, Ibaraki, Japan, 317-0077
Completed
90
Kitasato University Hospital
Sagamihara, Kanagawa, Japan, 252-0329
Actively Recruiting
91
Local Institution - 0979
Sendai, Miyagi, Japan, 980-8574
Withdrawn
92
Local Institution - 607
Sendai, Miyagi, Japan, 980-8574
Completed
93
Local Institution - 611
Nagasaki, Nagasaki, Japan, 8528511
Withdrawn
94
Local Institution - 604
Sakai, Osaka, Japan, 5900197
Completed
95
Local Institution - 602
Shibuya City, Tokyo, Japan, 150-8935
Completed
96
NTT Medical Center Tokyo
Shinagawa City, Tokyo, Japan, 141-8625
Actively Recruiting
97
Local Institution - 612
Chiba, Japan, 260-0852
Completed
98
Shonan Kamakura General Hospital
Kamakura, Japan, 247-8533
Actively Recruiting
99
Osaka Metropolitan University Hospital
Osaka, Japan, 545-8586
Actively Recruiting
100
Chronic Care Center
Hazmiyeh, Lebanon, 00961
Actively Recruiting
101
Local Institution - 545
Johor Bahru, Johor, Malaysia, 80100
Completed
102
Hospital Sultanah Bahiyah
Alor Star, Kedah, Malaysia, 05460
Actively Recruiting
103
Local Institution - 544
Kuala Lumpur, Kuala Lumpur, Malaysia, 59100
Completed
104
Hospital Raja Permaisuri Bainun
Ipoh, Perak, Malaysia, 30990
Actively Recruiting
105
Queen Elizabeth Hospital
Kota Kinabalu, Sabah, Malaysia, 88586
Actively Recruiting
106
Hospital Umum Sarawak
Kuching, Sarawak, Malaysia, 93586
Actively Recruiting
107
Local Institution - 580
Amsterdam, Netherlands, 1081 HV
Completed
108
Local Institution - 681
Barakaldo, Spain, 48903
Completed
109
Local Institution - 686
Barcelona, Spain, 08908
Completed
110
Local Institution - 685
Barcelona, Spain, 8035
Completed
111
Local Institution - 687
Madrid, Spain, 28028
Completed
112
Local Institution - 682
Oviedo, Spain, 33011
Completed
113
Local Institution - 684
Salamanca, Spain, 37007
Completed
114
Local Institution - 680
Seville, Spain, 41013
Completed
115
Local Institution - 683
Valencia, Spain, 46026
Completed
116
Local Institution - 720
Gothenburg, Sweden, 413 45
Completed
117
Local Institution - 722
Lund, Sweden, SE-221 85
Completed
118
Local Institution - 721
Stockholm, Sweden, 141 86
Completed
119
Local Institution - 760
Kaohsiung, San Ming Dist., Taiwan, 807
Completed
120
Local Institution - 762
Taichung, Taiwan, 40447
Completed
121
Local Institution - 761
Taipei, Taiwan, 100225
Completed
122
Chulalongkorn University Faculty of Medicine - King Chulalongkorn Memorial Hospital
Bangkok, Thailand, 10330
Actively Recruiting
123
Siriraj Hospital Mahidol University
Bangkok, Thailand, 10700
Actively Recruiting
124
Chiang Mai University - Maharaj Nakorn Chiang Mai Hospital
Chiang Mai, Thailand, 50200
Actively Recruiting
125
University Hospital Farhat Hached
Sousse, Tunisia, 4031
Actively Recruiting
126
Bone Marrow Transplant Center
Tunis, Tunisia, 1006
Actively Recruiting
127
Aziza Othmana Hospital
Tunis, Tunisia, 1008
Actively Recruiting
128
Military Hospital of Tunis
Tunis, Tunisia, 1008
Actively Recruiting
129
Local Institution - 881
Adana, Turkey (Türkiye), 01130
Completed
130
Local Institution - 885
Ankara, Turkey (Türkiye), 06590
Completed
131
Local Institution - 882
Istanbul, Turkey (Türkiye), 34093
Completed
132
Local Institution - 884
Istanbul, Turkey (Türkiye), 34098
Completed
133
Local Institution - 880
Izmir, Turkey (Türkiye), 35100
Completed
134
Local Institution - 883
Mersin, Turkey (Türkiye), 33343
Completed
135
Local Institution - 925
Aberdeen, United Kingdom, AB25 2ZN
Completed
136
Local Institution - 921
Leeds, United Kingdom, LS9 7TF
Withdrawn
137
Local Institution - 923
London, United Kingdom, E1 1BB
Completed
138
Whittington Hospital
London, United Kingdom, N19 5NF
Actively Recruiting
139
University College London Hospitals NHS Foundation Trust - University College Hospital
London, United Kingdom, NW1 2BU
Actively Recruiting
140
Local Institution - 928
London, United Kingdom, SE1 9RT
Completed
141
Local Institution - 924
London, United Kingdom, SE5 9RS
Completed
142
Local Institution - 929
Oxford, United Kingdom, OX3 7LE
Withdrawn
143
Local Institution - 926
Sutton in Ashfield, United Kingdom, NG17 4JL
Withdrawn
B
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First line of the email MUST contain NCT # and Site #.
Study Type
INTERVENTIONAL
Masking
NONE
Allocation
NA
Model
SINGLE_GROUP
Primary Purpose
TREATMENT
Number of Arms
1
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Khaled M Musallam, Maria Domenica Cappellini, Antonis Kattamis...
https://pubmed.ncbi.nlm.nih.gov/41857682