Study of Sotatercept for the Treatment of Anemia in low-or Intermediate-1 Risk Myelodysplastic Syndromes (MDS) or Non-proliferative Chronic Myelomonocytic Leukemia (CMML)
NCT ID: NCT01736683
Last Updated: 2022-10-24
Study Results
Outcome measurements, participant flow, baseline characteristics, and adverse events have been published for this study.
View full resultsBasic Information
Get a concise snapshot of the trial, including recruitment status, study phase, enrollment targets, and key timeline milestones.
COMPLETED
PHASE2
74 participants
INTERVENTIONAL
2012-11-28
2018-04-30
Brief Summary
Review the sponsor-provided synopsis that highlights what the study is about and why it is being conducted.
Related Clinical Trials
Explore similar clinical trials based on study characteristics and research focus.
A Study of Etavopivat for the Treatment of Anemia in Patients With Myelodysplastic Syndromes (MDS)
NCT05568225
A Study of Momelotinib in Participants With Low-risk Myelodysplastic Syndrome
NCT06847867
Combination of Sorafenib and Vorinostat in Poor-risk Acute Myelogenous Leukemia (AML) and High Risk Myelodysplastic Syndrome (MDS)
NCT00875745
Phase I/II Trial to Investigate BI 836858 in Myelodysplastic Syndromes
NCT02240706
The Role of Ruxolitinib in Secondary Acute Myelogenous Leukemia Evolving From Myeloproliferative Neoplasm
NCT03558607
Detailed Description
Dive into the extended narrative that explains the scientific background, objectives, and procedures in greater depth.
Conditions
See the medical conditions and disease areas that this research is targeting or investigating.
Study Design
Understand how the trial is structured, including allocation methods, masking strategies, primary purpose, and other design elements.
RANDOMIZED
PARALLEL
TREATMENT
NONE
Study Groups
Review each arm or cohort in the study, along with the interventions and objectives associated with them.
Sotatercept 0.1 mg/kg
Sotatercept 0.1 mg/kg
Sotatercept
Sotatercept is supplied as a lyophilized powder that is reconstituted using Water for Injection (WFI) and administered as a subcutaneous injection (SC) injection by the study staff at the clinical site.
Sotatercept 0.3 mg/kg
Sotatercept 0.3 mg/kg
Sotatercept
Sotatercept is supplied as a lyophilized powder that is reconstituted using Water for Injection (WFI) and administered as a subcutaneous injection (SC) injection by the study staff at the clinical site.
Sotatercept 0.5 mg/kg
Sotatercept 0.5 mg/kg
Sotatercept
Sotatercept is supplied as a lyophilized powder that is reconstituted using Water for Injection (WFI) and administered as a subcutaneous injection (SC) injection by the study staff at the clinical site.
Sotatercept 1.0 mg/kg
Sotatercept 1.0 mg/kg
Sotatercept
Sotatercept is supplied as a lyophilized powder that is reconstituted using Water for Injection (WFI) and administered as a subcutaneous injection (SC) injection by the study staff at the clinical site.
Sotatercept 1.5 mg/kg
Sotatercept 1.5 mg/kg
Sotatercept
Sotatercept is supplied as a lyophilized powder that is reconstituted using Water for Injection (WFI) and administered as a subcutaneous injection (SC) injection by the study staff at the clinical site.
Sotatercept 2.0 mg/kg
Sotatercept 2.0 mg/kg
Sotatercept
Sotatercept is supplied as a lyophilized powder that is reconstituted using Water for Injection (WFI) and administered as a subcutaneous injection (SC) injection by the study staff at the clinical site.
Interventions
Learn about the drugs, procedures, or behavioral strategies being tested and how they are applied within this trial.
Sotatercept
Sotatercept is supplied as a lyophilized powder that is reconstituted using Water for Injection (WFI) and administered as a subcutaneous injection (SC) injection by the study staff at the clinical site.
Other Intervention Names
Discover alternative or legacy names that may be used to describe the listed interventions across different sources.
Eligibility Criteria
Check the participation requirements, including inclusion and exclusion rules, age limits, and whether healthy volunteers are accepted.
Inclusion Criteria
* 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
Exclusion Criteria
* 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
18 Years
ALL
No
Sponsors
Meet the organizations funding or collaborating on the study and learn about their roles.
Merck Sharp & Dohme LLC
INDUSTRY
Responsible Party
Identify the individual or organization who holds primary responsibility for the study information submitted to regulators.
Principal Investigators
Learn about the lead researchers overseeing the trial and their institutional affiliations.
Rodrigo Ito, MD
Role: STUDY_DIRECTOR
Celgene Corporation
Locations
Explore where the study is taking place and check the recruitment status at each participating site.
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
Countries
Review the countries where the study has at least one active or historical site.
References
Explore related publications, articles, or registry entries linked to this study.
Komrokji R, Garcia-Manero G, Ades L, Prebet T, Steensma DP, Jurcic JG, Sekeres MA, Berdeja J, Savona MR, Beyne-Rauzy O, Stamatoullas A, DeZern AE, Delaunay J, Borthakur G, Rifkin R, Boyd TE, Laadem A, Vo B, Zhang J, Puccio-Pick M, Attie KM, Fenaux P, List AF. Sotatercept with long-term extension for the treatment of anaemia in patients with lower-risk myelodysplastic syndromes: a phase 2, dose-ranging trial. Lancet Haematol. 2018 Feb;5(2):e63-e72. doi: 10.1016/S2352-3026(18)30002-4. Epub 2018 Jan 10.
Provided Documents
Download supplemental materials such as informed consent forms, study protocols, or participant manuals.
Document Type: Study Protocol
Document Type: Statistical Analysis Plan
Other Identifiers
Review additional registry numbers or institutional identifiers associated with this trial.
ACE-011-MDS-001
Identifier Type: OTHER
Identifier Source: secondary_id
2012-002601-22
Identifier Type: EUDRACT_NUMBER
Identifier Source: secondary_id
7962-017
Identifier Type: -
Identifier Source: org_study_id
More Related Trials
Additional clinical trials that may be relevant based on similarity analysis.