Study of Sotatercept for the Treatment of Anemia in low-or Intermediate-1 Risk Myelodysplastic Syndromes (MDS) or Non-proliferative Chronic Myelomonocytic Leukemia (CMML)
Completed · Phase 2
Conditions studied: Anemia, Myelodysplastic Syndromes, Chronic Myelomonocytic Leukemia, Low to Intermediate-1 MDS, Myelodysplastic Syndromes (MDS), Chronic Myelomonocytic Leukemia (CMML)
In brief
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).
Key facts
- Study ID
- NCT01736683
- Run by
- Merck Sharp & Dohme LLC
- People needed
- 74
- Starts
- 2012-11-28
- Expected to finish
- 2018-04-30
- Last updated by the study team
- 2022-10-24
Who can join
Age: 18 and older. Sex: any. Healthy volunteers: not accepted.
You may qualify if…
- Men and women ≥ 18 years of age
- Documented diagnosis of myelodysplastic syndromes (MDS) or non-proliferative chronic myelomonocytic leukemia (CMML), white blood cells (WBC) ≤ 13,000 /mm\^3, World Health Organization (WHO) that meets International Prognostic Scoring System (IPSS) criteria for low or intermediate-1 risk disease
- Anemia, Hemoglobin (Hgb) ≤ 9.0 g/dL or ≥ 2 units of Red Blood Cells (RBCs) within 84 days
- No response or loss of response to Erythropoiesis-Stimulating Agents (ESAs) or erythropoetin (EPO) > 500 mU/ml
- Eastern Cooperative Group (ECOG) score ≤2.
- Creatinine < 1.5 * Upper Limit of the Normal (ULN)
- Total bilirubin ≤3.0 mg/dL
- Aspartate aminotransferase (AST)/Serum glutamic oxaloacetic transaminase (SGOT) \& Alanine Aminotransferase (ALT)/Serum Glutamic Pyruvic (SGPT) ≤3.0 * Upper Limit of Norma (ULN)
- Free of metastatic malignancy (other than MDS) for ≥2 years
- Highly effective methods of birth control for females and males
You may not qualify if…
- Chromosome 5q deletion
- Pregnant or breast feeding women and males who do not agree to use condom during the sexual contact with females of childbearing potential
- Major surgery within 30 days
- Incomplete recovery or incomplete healing of wounds from previous surgery
- Heart failure ≥3 (New York Heart Association (NYHA))
- Thromboembolic or myocardial infarction event within 6 months
- Concurrent anti-cancer cytotoxic chemotherapy
- History of severe allergic or anaphylactic reaction or hypersensitivity to recombinant protein
- Known positive for Human Immunovirus (HIV) or infectious Hepatitis type C or active infectious Hepatitis type B
- Clinically significant anemia unrelated to MDS
- Thrombocytopenia (<30,000/uL)
- Uncontrolled hypertension
- Treatment with another investigational drug or device within 28 days prior to Day 1
- Prior exposure to sotatercept (ACE-011)
- Any serious medical condition, lab abnormality or psychiatric illness
Where it is running
- 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, 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, France
- Centre Henri Becquerel — Rouen, France
- CHU Purpan — Toulouse, France
Full record on ClinicalTrials.gov
Trial information comes from ClinicalTrials.gov and is refreshed daily. TrialsForMe does not provide medical care and does not run the studies it lists.