Spots Global Cancer Trial Database for Study of Sotatercept for the Treatment of Anemia in low-or Intermediate-1 Risk Myelodysplastic Syndromes (MDS) or Non-proliferative Chronic Myelomonocytic Leukemia (CMML)
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Trial Identification
Brief Title: Study of Sotatercept for the Treatment of Anemia in low-or Intermediate-1 Risk Myelodysplastic Syndromes (MDS) or Non-proliferative Chronic Myelomonocytic Leukemia (CMML)
Official Title: An Open-label, Randomized, Phase 2, Parallel, Dose-Ranging, Multicenter Study of Sotatercept for the Treatment of Patients With Anemia and Low or Intermediate-1 Risk Myelodysplastic Syndromes or Non-proliferative Chronic Myelomonocytic Leukemia (CMML)
Study ID: NCT01736683
Interventions
Study Description
Brief Summary: The primary objective of this study is to determine a safe, tolerable and effective dose of sotatercept that results in the greatest frequency of improvement of anemia in patients diagnosed with low- or intermediate-1 risk myelodysplastic syndromes (MDS) or non-proliferative chronic myelomonocytic leukemia (CMML).
Detailed Description:
Eligibility
Minimum Age: 18 Years
Eligible Ages: ADULT, OLDER_ADULT
Sex: ALL
Healthy Volunteers: No
Locations
Rocky Mountain Cancer Center-Midtown, Denver, Colorado, United States
H. Lee Moffitt Cancer Center and Research Institute, Tampa, Florida, United States
Johns Hopkins, Baltimore, Maryland, United States
Dana-Farber / Harvard Cancer Institute, Boston, Massachusetts, United States
Monter Cancer Center, North Shore LIJ Health Systems, Lake Success, New York, United States
Columbia University Medical Center/New York-Presbyterian Hospital, New York, New York, United States
The Cleveland Clinic Foundation Hematology and Medical Oncology Rm 35, Cleveland, Ohio, United States
Sarah Cannon Research Inst, Nashville, Tennessee, United States
Texas Oncology Round Rock Cancer Center - Round Rock, Round Rock, Texas, United States
University of Texas Health Science Center at San Antonio, San Antonio, Texas, United States
Texas Oncology, P.A. - Tyler, Tyler, Texas, United States
Virginia Oncology Associates, Norfolk, Virginia, United States
Yakima Valley Memorial Hospital/ North Star Lodge, Yakima, Washington, United States
Centre Hospitalier Universitaire d'Avicennes, Bobigny Cedex, , France
Institute Paoli-Calmettes Service Haematology, Bp 156,, , France
CHRU de Lille-Hopital Claude Huriez Service des Maladies du Sang, Lille, , France
CHRU Nantes, Nantes, , France
Hopital Cochin Hematologie, Paris Cedex 14, , France
Centre Henri Becquerel, Rouen, , France
CHU Purpan, Toulouse, , France
Contact Details
Name: Rodrigo Ito, MD
Affiliation: Celgene Corporation
Role: STUDY_DIRECTOR
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