A Study to Evaluate Long-term Safety in Participants Who Have Participated in Other Luspatercept (ACE-536) Clinical Trials
Start Date
8/12/2019
Completion Date
5/12/2028
Summary
A Phase 3b, open-label, single-arm, rollover study to evaluate the long-term safety of luspatercept, to the following participants: * Participants receiving luspatercept on a parent protocol at the time of their transition to the rollover study, who tolerate the protocol-prescribed regimen in the parent trial and, in the opinion of the investigator, may derive clinical benefit from continuing treatment with luspatercept * Participants in the follow-up phase previously treated with luspatercept or placebo in the parent protocol will continue into long-term post-treatment follow-up in the rollover study until the follow-up commitments are met * The study design is divided into the Transition Phase, Treatment Phase and Follow-up Phase. Participants will enter transition phase and depending on their background will enter either the treatment phase or the Long-term Post-treatment Follow-up (LTPTFU) phase * Transition Phase is defined as one Enrollment visit * Treatment Phase: For participants in luspatercept treatment the dose and schedule of luspatercept in this study will be the same as the last dose and schedule in the parent luspatercept study. This does not apply to participants that are in long-term follow-up from the parent protocol * Follow-up Phase includes: \- 42 Day Safety Follow-up Visit * During the Safety Follow up, the participants will be followed for 42 days after the last dose of luspatercept, for the assessment of safety-related parameters and adverse event (AE) reporting \- Long-term Post-treatment Follow-up (LTPTFU) Phase * Participants will be followed for overall survival every 6 months for at least 5 years from first dose of luspatercept in the parent protocol, or 3 years of post-treatment from last dose, whichever occurs later, or until death, withdrawal of consent, study termination, or until a subject is lost to follow-up. Participants will also be monitored for progression to AML or any malignancies/pre-malignancies. New anticancer or disease related therapies should be collected at the same time schedule Participants transitioning from a parent luspatercept study in post-treatment follow-up (safety or LTPTFU) will continue from the same equivalent point in this rollover study. The ACE-536-LTFU-001 rollover study will be terminated, and relevant participants will discontinue from the study when all participants fulfill 5 years on the study, including treatment and follow-up.
Eligibility Criteria
Age Range: 18 years to No maximum
Interventions
Luspatercept
Conditions
Locations
Local Institution - 968
Los Angeles, California 90027-6062
United States
Local Institution - 971
Oakland, California 94609
United States
Local Institution - 978
Stanford, California 94305
United States
Local Institution - 975
Tampa, Florida 33612
United States
Local Institution - 970
Chicago, Illinois 60611
United States
Local Institution - 973
Boston, Massachusetts 02115
United States
Local Institution - 961
Detroit, Michigan 48201
United States
Local Institution - 969
New York, New York 10065
United States
Local Institution - 967
Cleveland, Ohio 44195
United States
Local Institution - 972
Philadelphia, Pennsylvania 19104
United States
Vanderbilt - Ingram Cancer Center
Nashville, Tennessee 37232-5505
United States
The University of Texas - MD Anderson Cancer Center
Houston, Texas 77030
United States
Local Institution - 100
South Brisbane, Queensland 4101
Australia
Royal Adelaide Hospital
Adelaide, South Australia 5000
Australia
Local Institution - 102
Clayton, Victoria 3168
Australia
Royal Prince Alfred Hospital
Camperdown, 2050
Australia
Local Institution - 182
Brasschaat, 2930
Belgium
Local Institution - 180
Bruges, 8000
Belgium
Local Institution - 183
Ghent, 9000
Belgium
Local Institution - 184
Leuven, 3000
Belgium
Local Institution - 220
Boulevard, Sofia 1797
Bulgaria
Local Institution - 221
Plovdiv, 4002
Bulgaria
Local Institution - 262
Toronto, Ontario M4N 3M5
Canada
Local Institution - 260
Toronto, Ontario M5G 2C4
Canada
Local Institution - 263
Toronto, Ontario M5G 2M9
Canada
Local Institution - 131
Beijing, Beijing Municipality 100730
China
Local Institution - 135
Guangzhou, Guangdong 510515
China
Local Institution - 132
Shanghai, Shanghai Municipality 200233
China
Local Institution - 134
Chengdu, Sichuan 610041
China
Local Institution - 130
Tianjin, Tianjin Municipality 300020
China
Local Institution - 133
Hangzhou, Zhejiang 310009
China
Local Institution - 305
Angers, 49033
France
Local Institution - 300
Créteil, 94010
France
Local Institution - 310
La Tronche, 38700
France
Local Institution - 306
Lille, 59037
France
Local Institution - 301
Marseille, 13385
France
Local Institution - 302
Paris, 75010
France
Local Institution - 307
Pessac, 33604
France
Local Institution - 304
Pierre-Bénite, 69495
France
Local Institution - 308
Strasbourg, 67091
France
Local Institution - 309
Toulouse, 31059
France
Local Institution - 303
Tours, 37044
France
Local Institution - 341
Berlin, 14195
Germany
Local Institution - 348
Dresden, 01307
Germany
Local Institution - 345
Düsseldorf, 40225
Germany
Local Institution - 346
Düsseldorf, 40479
Germany
Local Institution - 343
Halle, 06120
Germany
Local Institution - 342
Hamburg, 22081
Germany
Local Institution - 344
Hanover, 30625
Germany
Local Institution - 349
Leipzig, 04103
Germany
Local Institution - 340
Mainz, 55131
Germany
Local Institution - 347
München, 81675
Germany
Aghia Sophia' Children's General Hospital of Athens
Athens, 115 27
Greece
Local Institution - 380
Athens, 115 27
Greece
Local Institution - 384
Athens, 11527
Greece
Local Institution - 383
Rio Patras, 26500
Greece
Local Institution - 381
Thessaloniki, 54642
Greece
Local Institution - 425
Afula, 1834111
Israel
Local Institution - 420
Haifa, 3109601
Israel
Local Institution - 422
Jerusalem, 91031
Israel
Local Institution - 424
Jerusalem, 91120
Israel
Local Institution - 421
Nahariya, 22100
Israel
Local Institution - 423
Petah Tikva, 49100
Israel
Local Institution - 478
Florence, Tuscany 50134
Italy
Local Institution - 471
Florence, Tuscany 50139
Italy
Local Institution - 470
Allessandria, 15100
Italy
Local Institution - 464
Bologna, 40138
Italy
Local Institution - 466
Brindisi, 72100
Italy
Local Institution - 477
Cagliari, 09121
Italy
Local Institution - 462
Ferrara, 44124
Italy
Ente Ospedaliero Ospedali Galliera - Centro della Microcitemia e delle Anemie Congenite
Genoa, 16128
Italy
Local Institution - 473
Lecce, 73100
Italy
Maggiore Polyclinic Hospital, IRCCS Ca' Granda
Milan, 20122
Italy
Local Institution - 479
Modena, 41124
Italy
AORN A Cardarelli
Naples, 80131
Italy
AOU dell'Universita degli Studi della Campania Luigi Vanvitelli
Naples, 80131
Italy
Azienda Ospedaliero Universitaria S. Luigi Gonzaga
Orbassano, 10043
Italy
Local Institution - 469
Pavia, 27100
Italy
Local Institution - 468
Reggio Calabria, 89124
Italy
Local Institution - 465
Roma, 133
Italy
Local Institution - 474
Rozzano, 20089
Italy
Local Institution - 472
Varese, 21100
Italy
Local Institution - 463
Verona, 37134
Italy
Local Institution - 610
Nagoya, Aichi-ken 460-0001
Japan
Local Institution - 601
Kamogawa, Chiba 296-0041
Japan
Matsuyama Red Cross Hospital
Matsuyama, Ehime 790-8524
Japan
Ogaki Municipal Hospital
Ōgaki, Gifu 503-8502
Japan
Japanese Red Cross Society Himeji Hospital
Himeji, Hyōgo 6708540
Japan
Local Institution - 605
Hitachi, Ibaraki 317-0077
Japan
Local Institution - 603
Sagamihara, Kanagawa 252-0329
Japan
Local Institution - 0979
Sendai, Miyagi 980-8574
Japan
Local Institution - 607
Sendai, Miyagi 980-8574
Japan
Local Institution - 611
Nagasaki, Nagasaki 8528511
Japan
Local Institution - 604
Sakai, Osaka 5900197
Japan
Local Institution - 602
Shibuya City, Tokyo 150-8935
Japan
NTT Medical Center Tokyo
Shinagawa City, Tokyo 141-8625
Japan
Local Institution - 612
Chiba, 260-0852
Japan
Shonan Kamakura General Hospital
Kamakura, 247-8533
Japan
Local Institution - 609
Osaka, 545-8586
Japan
Chronic Care Center
Hazmiyeh, 00961
Lebanon
Local Institution - 545
Johor Bahru, Johor 80100
Malaysia
Hospital Sultanah Bahiyah
Alor Star, Kedah 05460
Malaysia
Local Institution - 544
Kuala Lumpur, Kuala Lumpur 59100
Malaysia
Hospital Raja Permaisuri Bainun
Ipoh, Perak 30990
Malaysia
Queen Elizabeth Hospital
Kota Kinabalu, Sabah 88586
Malaysia
Hospital Umum Sarawak
Kuching, Sarawak 93586
Malaysia
Local Institution - 580
Amsterdam, 1081 HV
Netherlands
Local Institution - 681
Barakaldo, 48903
Spain
Local Institution - 686
Barcelona, 08908
Spain
Local Institution - 685
Barcelona, 8035
Spain
Local Institution - 687
Madrid, 28028
Spain
Local Institution - 682
Oviedo, 33011
Spain
Local Institution - 684
Salamanca, 37007
Spain
Local Institution - 680
Seville, 41013
Spain
Local Institution - 683
Valencia, 46026
Spain
Local Institution - 720
Gothenburg, 413 45
Sweden
Local Institution - 722
Lund, SE-221 85
Sweden
Local Institution - 721
Stockholm, 141 86
Sweden
Local Institution - 760
Kaohsiung, San Ming Dist., 807
Taiwan
Local Institution - 762
Taichung, 40447
Taiwan
Local Institution - 761
Taipei, 100225
Taiwan
Chulalongkorn University Faculty of Medicine - King Chulalongkorn Memorial Hospital
Bangkok, 10330
Thailand
Siriraj Hospital Mahidol University
Bangkok, 10700
Thailand
Chiang Mai University - Maharaj Nakorn Chiang Mai Hospital
Chiang Mai, 50200
Thailand
University Hospital Farhat Hached
Sousse, 4031
Tunisia
Bone Marrow Transplant Center
Tunis, 1006
Tunisia
Aziza Othmana Hospital
Tunis, 1008
Tunisia
Military Hospital of Tunis
Tunis, 1008
Tunisia
Local Institution - 881
Adana, 01130
Turkey (Türkiye)
Local Institution - 885
Ankara, 06590
Turkey (Türkiye)
Local Institution - 882
Istanbul, 34093
Turkey (Türkiye)
Local Institution - 884
Istanbul, 34098
Turkey (Türkiye)
Local Institution - 880
Izmir, 35100
Turkey (Türkiye)
Local Institution - 883
Mersin, 33343
Turkey (Türkiye)
Local Institution - 925
Aberdeen, AB25 2ZN
United Kingdom
Local Institution - 921
Leeds, LS9 7TF
United Kingdom
Local Institution - 923
London, E1 1BB
United Kingdom
Whittington Hospital
London, N19 5NF
United Kingdom
University College London Hospitals NHS Foundation Trust - University College Hospital
London, NW1 2BU
United Kingdom
Local Institution - 928
London, SE1 9RT
United Kingdom
Local Institution - 924
London, SE5 9RS
United Kingdom
Local Institution - 929
Oxford, OX3 7LE
United Kingdom
Local Institution - 926
Sutton in Ashfield, NG17 4JL
United Kingdom