Spots Global Cancer Trial Database for A Safety and Efficacy Study to Evaluate Luspatercept in Subjects With Myeloproliferative Neoplasm-associated Myelofibrosis Who Have Anemia With and Without Red Blood Cell-transfusion Dependence
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Trial Identification
Brief Title: A Safety and Efficacy Study to Evaluate Luspatercept in Subjects With Myeloproliferative Neoplasm-associated Myelofibrosis Who Have Anemia With and Without Red Blood Cell-transfusion Dependence
Official Title: A Phase-2 Study To Determine Efficacy and Safety of Luspatercept in Subjects With Myeloproliferative Neoplasm-Associated Myelofibrosis and Anemia With or Without Red Blood Cell-Transfusion Dependence
Study ID: NCT03194542
Interventions
Study Description
Brief Summary: This is a Phase 2, multicenter, open-label study to evaluate the efficacy and safety of luspatercept in subjects with MPN-associated myelofibrosis and anemia with and without RBC-transfusion dependence. The study is divided into a Screening Period, a Treatment Period (consisting of a Primary Phase, a Day 169 Disease Response Assessment, and an Extension Phase), followed by a Posttreatment Follow-up Period.
Detailed Description: Subjects satisfying the eligibility criteria will be assigned to 1 of the following cohorts (which are enrolling in parallel) based on their eligibility: * Cohort 1 (subjects with anemia only that are not currently receiving RBC transfusions) - Cohort 2: (subjects that are RBC-transfusion dependent) * Cohort 3A: (subjects on ruxolitinib as part of their standard of care therapy that have anemia only) * Cohort 3B: (subjects on ruxolitinib as part of their standard of care therapy that are RBC-transfusion dependent) Overall, the study will enroll approximately 100 subjects worldwide.
Eligibility
Minimum Age: 18 Years
Eligible Ages: ADULT, OLDER_ADULT
Sex: ALL
Healthy Volunteers: No
Locations
Local Institution - 102, Phoenix, Arizona, United States
Mayo Clinic - Arizona, Phoenix, Arizona, United States
Local Institution - 103, Stanford, California, United States
Stanford Cancer Center, Stanford, California, United States
Local Institution - 101, Jacksonville, Florida, United States
Mayo Clinic - Jacksonville, Jacksonville, Florida, United States
Local Institution - 107, Orange City, Florida, United States
Mid Florida Hematology and Oncology Centers, PA, Orange City, Florida, United States
H. Lee Moffitt Cancer Center and Research Institute, Tampa, Florida, United States
Local Institution - 108, Tampa, Florida, United States
Local Institution - 104, New York, New York, United States
Mount Sinai Medical Center, New York, New York, United States
Cleveland Clinic, Cleveland, Ohio, United States
Local Institution - 109, Cleveland, Ohio, United States
Avera Research Institute, Sioux Falls, South Dakota, United States
Local Institution - 105, Sioux Falls, South Dakota, United States
Local Institution - 100, Houston, Texas, United States
MD Anderson Cancer Center The University of Texas, Houston, Texas, United States
Local Institution - 106, San Antonio, Texas, United States
University of Texas Health Science Center at San Antonio, San Antonio, Texas, United States
CHRU de Brest - Hopital Morvan, Brest Cedex, , France
Local Institution - 203, Brest Cedex, , France
Centre Hospitalier de Lens, Lens Cedex, , France
Local Institution - 201, Lens Cedex, , France
Hopital Saint Louis, Paris, , France
Local Institution - 200, Paris, , France
Gustave Roussy, Villejuif CEDEX, , France
Local Institution - 202, Villejuif CEDEX, , France
Azienda Ospedaliera Papa Giovanni XXIII, Bergamo, , Italy
Local Institution - 304, Bergamo, , Italy
Azienda Ospedaliera Universitaria Careggi, Firenze, , Italy
Local Institution - 300, Firenze, , Italy
Fondazione IRCCS Policlinico San Matteo, Pavia, , Italy
Local Institution - 301, Pavia, , Italy
Istituto Clinico Humanitas, Rozzano (MI), , Italy
Local Institution - 303, Rozzano (MI), , Italy
Local Institution - 302, Varese, , Italy
Ospedale di Circolo di Varese, Varese, , Italy
Belfast Health and Social Care Trust, Belfast Northern Ireland, , United Kingdom
Local Institution - 404, Cardiff, , United Kingdom
University Hospital of Wales, Cardiff, , United Kingdom
Local Institution - 400, Headington, Oxford, , United Kingdom
University of Oxford, Headington, Oxford, , United Kingdom
Guy's and St Thomas' NHS Foundation Trust - Guy's Hospital, London, , United Kingdom
Local Institution - 403, London, , United Kingdom
Imperial College London, London, , United Kingdom
Local Institution - 402, London, , United Kingdom
Contact Details
Name: Bristol-Myers Squibb
Affiliation: Bristol-Myers Squibb
Role: STUDY_DIRECTOR
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