A Study to Compare the Efficacy and Safety of Luspatercept (ACE-536) Versus Epoetin Alfa for the Treatment of Anemia Due to IPSS-R Very Low, Low, or Intermediate Risk Myelodysplastic Syndromes (MDS) Participants Who Require Red Blood Cell Transfusions and Are ESA Naïve

Running, not enrolling · Phase 3

Conditions studied: Myelodysplastic Syndromes

In brief

The purpose of this study is to determine the effectiveness of luspatercept (ACE-536) compared to epoetin alfa on red blood cell (RBC) transfusion independence (for at least 12 weeks) with a concurrent hemoglobin increase of at least 1.5 g/dL in participants with anemia due to revised international prognostic scoring system (IPSS-R) very low, low, or intermediate risk myelodysplastic syndromes (MDS) who require RBC transfusions and have never been exposed to erythropoiesis stimulating agent (ESA).

Key facts

Study ID

NCT03682536

Run by

Celgene

People needed

363

Starts

2019-01-02

Expected to finish

2027-09-28

Last updated by the study team

2024-11-20

Who can join

Age: 18 and older. Sex: any. Healthy volunteers: not accepted.

You may qualify if…

• Documented diagnosis of Myelodysplastic syndromes (MDS) according to WHO 2016 classification that meets revised international prognostic scoring system (IPSS-R) classification of very low, low, or intermediate risk disease, and have < 5% blasts in bone marrow
• Endogenous serum erythropoietin (sEPO) level of < 500 U/L
• Requires Red blood cell (RBC) transfusions, as documented by the criteria: Average transfusion requirement of 2 - 6 units/8 weeks of packed red blood cells (pRBCs) confirmed for a minimum of 8 weeks immediately preceding randomization
• Eastern Cooperative Oncology Group (ECOG) score of 0, 1, or 2

You may not qualify if…

• Clinically significant anemia due to iron, vitamin B12, or folate deficiencies, or autoimmune or hereditary hemolytic anemia, or hypothyroidism, or any type of known clinically significant bleeding or sequestration or drug induced anemia
• Known history of diagnosis of Acute myeloid leukemia (AML)
• Uncontrolled hypertension, defined as repeated elevations of systolic blood pressure (SBP) of ≥ 150 mmHg and/or diastolic blood pressure (DBP) ≥ 100 mmHg despite adequate treatment
• Other protocol-defined inclusion/exclusion criteria apply

Where it is running

• Local Institution - 115 — San Diego, California, United States
• Local Institution - 101 — Whittier, California, United States
• Local Institution - 104 — New Haven, Connecticut, United States
• Local Institution - 136 — Washington D.C., District of Columbia, United States
• Local Institution - 119 — Hudson, Florida, United States
• Local Institution - 120 — St. Petersburg, Florida, United States
• Local Institution - 122 — Tallahassee, Florida, United States
• Local Institution - 108 — Tampa, Florida, United States
• Local Institution - 118 — West Palm Beach, Florida, United States
• Local Institution - 102 — Paducah, Kentucky, United States
• Local Institution - 123 — Bethesda, Maryland, United States
• Local Institution - 117 — Kansas City, Missouri, United States
• Local Institution - 134 — East Brunswick, New Jersey, United States
• Local Institution - 113 — Hackensack, New Jersey, United States
• Local Institution - 105 — Greenville, North Carolina, United States
• Local Institution - 131 — Portland, Oregon, United States
• Univ of Pittsburgh Medical Center — Pittsburgh, Pennsylvania, United States
• Local Institution - 111 — Rock Hill, South Carolina, United States
• Tennessee Oncology — Nashville, Tennessee, United States
• Baylor University Medical Center — Dallas, Texas, United States
• Local Institution - 109 — Houston, Texas, United States
• Local Institution - 114 — Salt Lake City, Utah, United States
• Local Institution - 132 — Charlottesville, Virginia, United States
• Local Institution - 127 — Chesapeake, Virginia, United States
• Local Institution - 107 — Berkeley, California, United States

Full record on ClinicalTrials.gov

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