Study of Sotatercept for the Treatment of Anemia in low-or Intermediate-1 Risk Myelodysplastic Syndromes (MDS) or Non-proliferative Chronic Myelomonocytic Leukemia (CMML)

Status: Recruiting
Phase: Phase 2
Diagnosis: Leukemia/MDS
NCT ID: NCT01736683 (View complete trial on ClinicalTrials.gov)
DFCI Protocol ID: 13-022

 

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 MDS or non-proliferative chronic myelomonocytic leukemia (CMML).

 

Conducting Institutions:
Dana-Farber Cancer Institute, Brigham and Women's Hospital

Overall PI:
David Steensma, MD, Dana-Farber Cancer Institute

Site-responsible Investigators:

Contacts:
Dana-Farber Cancer Institute: Ilene Galinsky, 617-632-3902, igalinsky@partners.org

Eligibility Criteria

Inclusion Criteria: - 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 /mm3, 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 X 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 x Upper Limit of Norma (ULN) - Free of metastatic malignancy (other than MDS) for ≥2 years - Highly effective methods of birth control for females & males Exclusion Criteria: - 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
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