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A Study to Evaluate Long-term Safety in Participants Who Have Participated in Other Luspatercept (ACE-536) Clinical Trials
Sponsor: Celgene
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.
Official title: A Phase 3b, Open-label, Single-arm, Rollover Study to Evaluate Long-term Safety in Subjects Who Have Participated in Other Luspatercept (ACE-536) Clinical Trials
Key Details
Gender
All
Age Range
18 Years - Any
Study Type
INTERVENTIONAL
Enrollment
665
Start Date
2019-08-12
Completion Date
2028-05-12
Last Updated
2025-11-12
Healthy Volunteers
No
Conditions
Interventions
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
Locations (143)
Childrens Hospital Los Angeles RHU
Los Angeles, California, United States
Local Institution - 971
Oakland, California, United States
Local Institution - 978
Stanford, California, United States
Local Institution - 975
Tampa, Florida, United States
Local Institution - 970
Chicago, Illinois, United States
Local Institution - 973
Boston, Massachusetts, United States
Local Institution - 961
Detroit, Michigan, United States
Local Institution - 969
New York, New York, United States
Local Institution - 967
Cleveland, Ohio, United States
Local Institution - 972
Philadelphia, Pennsylvania, United States
Vanderbilt - Ingram Cancer Center
Nashville, Tennessee, United States
The University of Texas - MD Anderson Cancer Center
Houston, Texas, United States
Local Institution - 100
South Brisbane, Queensland, Australia
Royal Adelaide Hospital
Adelaide, South Australia, Australia
Local Institution - 102
Clayton, Victoria, Australia
Royal Prince Alfred Hospital
Camperdown, Australia
Local Institution - 182
Brasschaat, Belgium
Local Institution - 180
Bruges, Belgium
Local Institution - 183
Ghent, Belgium
Local Institution - 184
Leuven, Belgium
Local Institution - 220
Boulevard, Sofia, Bulgaria
Local Institution - 221
Plovdiv, Bulgaria
Local Institution - 262
Toronto, Ontario, Canada
Local Institution - 260
Toronto, Ontario, Canada
Local Institution - 263
Toronto, Ontario, Canada
Local Institution - 131
Beijing, Beijing Municipality, China
Local Institution - 135
Guangzhou, Guangdong, China
Local Institution - 132
Shanghai, Shanghai Municipality, China
Local Institution - 134
Chengdu, Sichuan, China
Local Institution - 130
Tianjin, Tianjin Municipality, China
Local Institution - 133
Hangzhou, Zhejiang, China
Local Institution - 305
Angers, France
Local Institution - 300
Créteil, France
Local Institution - 310
La Tronche, France
Local Institution - 306
Lille, France
Local Institution - 301
Marseille, France
Local Institution - 302
Paris, France
Local Institution - 307
Pessac, France
Local Institution - 304
Pierre-Bénite, France
Local Institution - 308
Strasbourg, France
Local Institution - 309
Toulouse, France
Local Institution - 303
Tours, France
Local Institution - 341
Berlin, Germany
Local Institution - 348
Dresden, Germany
Local Institution - 345
Düsseldorf, Germany
Local Institution - 346
Düsseldorf, Germany
Local Institution - 343
Halle, Germany
Local Institution - 342
Hamburg, Germany
Local Institution - 344
Hanover, Germany
Local Institution - 349
Leipzig, Germany
Local Institution - 340
Mainz, Germany
Local Institution - 347
München, Germany
Aghia Sophia' Children's General Hospital of Athens
Athens, Greece
Laiko General Hospital of Athens - Center of Thalassemia
Athens, Greece
Local Institution - 384
Athens, Greece
Local Institution - 383
Rio Patras, Greece
Local Institution - 381
Thessaloniki, Greece
Local Institution - 425
Afula, Israel
Local Institution - 420
Haifa, Israel
Local Institution - 422
Jerusalem, Israel
Local Institution - 424
Jerusalem, Israel
Local Institution - 421
Nahariya, Israel
Local Institution - 423
Petah Tikva, Israel
Local Institution - 478
Florence, Tuscany, Italy
Local Institution - 471
Florence, Tuscany, Italy
Local Institution - 470
Allessandria, Italy
Local Institution - 464
Bologna, Italy
Local Institution - 466
Brindisi, Italy
Local Institution - 477
Cagliari, Italy
Local Institution - 462
Ferrara, Italy
Ente Ospedaliero Ospedali Galliera - Centro della Microcitemia e delle Anemie Congenite
Genoa, Italy
Local Institution - 473
Lecce, Italy
Maggiore Polyclinic Hospital, IRCCS Ca' Granda
Milan, Italy
Local Institution - 479
Modena, Italy
AORN A Cardarelli
Naples, Italy
AOU dell'Universita degli Studi della Campania Luigi Vanvitelli
Naples, Italy
Azienda Ospedaliero Universitaria S. Luigi Gonzaga
Orbassano, Italy
Local Institution - 469
Pavia, Italy
Local Institution - 468
Reggio Calabria, Italy
Local Institution - 465
Roma, Italy
Local Institution - 474
Rozzano, Italy
Local Institution - 472
Varese, Italy
Local Institution - 463
Verona, Italy
Local Institution - 610
Nagoya, Aichi-ken, Japan
Local Institution - 601
Kamogawa, Chiba, Japan
Matsuyama Red Cross Hospital
Matsuyama, Ehime, Japan
Ogaki Municipal Hospital
Ōgaki, Gifu, Japan
Japanese Red Cross Society Himeji Hospital
Himeji, Hyōgo, Japan
Local Institution - 605
Hitachi, Ibaraki, Japan
Kitasato University Hospital
Sagamihara, Kanagawa, Japan
Local Institution - 0979
Sendai, Miyagi, Japan
Tohoku University Hospital
Sendai, Miyagi, Japan
Local Institution - 611
Nagasaki, Nagasaki, Japan
Japanese Red Cross Medical Center
Shibuya City, Tokyo, Japan
NTT Medical Center Tokyo
Shinagawa City, Tokyo, Japan
Local Institution - 612
Chiba, Japan
Shonan Kamakura General Hospital
Kamakura, Japan
Osaka Metropolitan University Hospital
Osaka, Japan
Local Institution - 604
Osaka, Japan
Chronic Care Center
Hazmiyeh, Lebanon
Local Institution - 545
Johor Bahru, Johor, Malaysia
Hospital Sultanah Bahiyah
Alor Star, Kedah, Malaysia
University Malaya Medical Centre
Kuala Lumpur, Kuala Lumpur, Malaysia
Hospital Raja Permaisuri Bainun
Ipoh, Perak, Malaysia
Queen Elizabeth Hospital
Kota Kinabalu, Sabah, Malaysia
Hospital Umum Sarawak
Kuching, Sarawak, Malaysia
Local Institution - 580
Amsterdam, Netherlands
Local Institution - 681
Barakaldo, Spain
Local Institution - 686
Barcelona, Spain
Local Institution - 685
Barcelona, Spain
Local Institution - 687
Madrid, Spain
Local Institution - 682
Oviedo, Spain
Local Institution - 684
Salamanca, Spain
Local Institution - 680
Seville, Spain
Local Institution - 683
Valencia, Spain
Local Institution - 720
Gothenburg, Sweden
Local Institution - 722
Lund, Sweden
Local Institution - 721
Stockholm, Sweden
Local Institution - 760
Kaohsiung, San Ming Dist., Taiwan
China Medical University Hospital
Taichung, Taiwan
Local Institution - 761
Taipei, Taiwan
Chulalongkorn University Faculty of Medicine - King Chulalongkorn Memorial Hospital
Bangkok, Thailand
Siriraj Hospital Mahidol University
Bangkok, Thailand
Chiang Mai University - Maharaj Nakorn Chiang Mai Hospital
Chiang Mai, Thailand
University Hospital Farhat Hached
Sousse, Tunisia
Bone Marrow Transplant Center
Tunis, Tunisia
Aziza Othmana Hospital
Tunis, Tunisia
Military Hospital of Tunis
Tunis, Tunisia
Local Institution - 881
Adana, Turkey (Türkiye)
Local Institution - 885
Ankara, Turkey (Türkiye)
Local Institution - 882
Istanbul, Turkey (Türkiye)
Local Institution - 884
Istanbul, Turkey (Türkiye)
Local Institution - 880
Izmir, Turkey (Türkiye)
Local Institution - 883
Mersin, Turkey (Türkiye)
Local Institution - 925
Aberdeen, United Kingdom
Local Institution - 921
Leeds, United Kingdom
Local Institution - 923
London, United Kingdom
Whittington Hospital
London, United Kingdom
University College London Hospitals NHS Foundation Trust - University College Hospital
London, United Kingdom
Local Institution - 928
London, United Kingdom
Local Institution - 924
London, United Kingdom
Local Institution - 929
Oxford, United Kingdom
Local Institution - 926
Sutton in Ashfield, United Kingdom