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: | Completed |
---|---|
Conditions: | Blood Cancer, Anemia |
Therapuetic Areas: | Hematology, Oncology |
Healthy: | No |
Age Range: | 18 - Any |
Updated: | 6/16/2018 |
Start Date: | November 28, 2012 |
End Date: | April 30, 2018 |
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)
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).
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).
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
We found this trial at
14
sites
12902 USF Magnolia Dr
Tampa, Florida 33612
Tampa, Florida 33612
(888) 663-3488
H. Lee Moffitt Cancer Center & Research Institute Moffitt Cancer Center in Tampa, Florida, has...
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4502 Medical Drive
San Antonio, Texas 78284
San Antonio, Texas 78284
(210) 567-7000
University of Texas Health Science Center at San Antonio The University of Texas Health Science...
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Johns Hopkins The Johns Hopkins University opened in 1876, with the inauguration of its first...
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Virginia Oncology Associates Virginia Oncology Associates is an oncology and hematology practice of physicians, specializing...
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