Phase 3 Clinical Trial Comparing Luspatercept VS Epoetin Alfa in Patients with Very Low – Intermediate Risk MDS Who Are Not Transfusion Dependent ELEMENT-MDS
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What's the purpose of this trial?

Researchers are hoping to learn more about the differences in how the drug, luspatercept, may help to prevent or delay the need for red blood cell (RBC) transfusions when compared to epoetin alfa in patients with myelodysplastic syndrome (MDS). 

This trial is currently open and accepting patients.

What will happen during the trial?

This clinical trial is evaluating the drug luspatercept. If you choose to participate in the study, you will receive either luspatercept or epoetin alfa. This trial is randomized, which means that participants will be randomly assigned into either the luspatercept or epoetin alfa group. 

You will receive the study treatment at your hospital or study site, or possibly at home (only if receiving epoetin alfa). Epoetin alfa will be administered by a nurse or other trained staff member. The study treatment will be administered via subcutaneous injection (injection under the skin) in your upper arm, abdomen, and/or thigh. Each injection will take less than one minute. 

Participants receiving luspatercept will receive treatment every three weeks, and participants receiving epoetin alfa will receive treatment every week. Participants may remain on this study for up to two years (or longer), as long as they continue to receive benefit from treatment.  

You may be able to join this trial if you:

The following criteria is a partial list of reasons why patients may be eligible to participate in this clinical trial. Further evaluation with a medical professional is required.

  • have lower risk MDS (Lower risk includes very low, low and intermediate risk).
  • have current symptom(s) of anemia (this may include fatigue, weakness, shortness or breath, or dizziness)
  • do not currently require regular red blood cell transfusions.
  • have not previously been treated for MDS.

Additional Trial Information

Phase 3

Enrollment: 360 patients (estimated)

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Trial Links

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Trial Locations

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California

Clovis Community Cancer Institute

Clovis, CA

Open and Accepting

John Muir Medical Center

Concord, CA

Open and Accepting

Compassionate Cancer Care

Fountain Valley, CA

Open and Accepting

Cancer and Blood Specialty Clinic

Los Alamitos, CA

Open and Accepting

Providence St. Joseph Hospital Orange

Orange, CA

Not Yet Accepting

Ventura County Hematology-Oncology Specialists

Oxnard, CA

Open and Accepting

Connecticut

Hartford Hospital

Hartford, CT

Open and Accepting

Smilow Cancer Hospital at Yale New Haven

New Haven, CT

Open and Accepting

Florida

Advanced Research

Coral Springs, FL

Open and Accepting

Florida Cancer Specialists - South - Fort Myers (Broadway)

Fort Myers, FL

Open and Accepting

Baptist MD Anderson

Jacksonville, FL

Open and Accepting

D & H National Research Centers

Margate, FL

Open and Accepting

Boca Raton Clinical Research (BRCR) Medical Center

Plantation, FL

Open and Accepting

Florida Cancer Specialists - North - St. Petersburg North

St. Petersburg, FL

Open and Accepting

Moffitt Cancer Center Magnolia Campus

Tampa, FL

Not Yet Accepting

Hawaii

Hawaii Cancer Care - Waterfront Plaza

Honolulu, HI

Not Yet Accepting

Illinois

Orchard Healthcare Research Inc.

Skokie, IL

Open and Accepting

Louisiana

Our Lady of the Lake Regional Medical Center

Baton Rouge, LA

Open and Accepting

Pontchartrain Cancer Center

Covington, LA

Open and Accepting

Maryland

American Oncology Partners of Maryland (Bethesda) The Center for Cancer & Blood Disorders - Bethesda

Bethesda, MD

Open and Accepting

Minnesota

Metro-Minnesota Community Oncology Research Consortium (MMCORC)

St. Louis Park, MN

Open and Accepting

Mississippi

Hattiesburg Clinic

Hattiesburg, MS

Open and Accepting

New Jersey

John Theurer Cancer Center at Hackensack University Medical Center  Hackensack Meridian Health

Hackensack, NJ

Open and Accepting

Ohio

Ohio State University Comprehensive Cancer Center James Cancer Hospital and Solove Research Institute

Columbus, OH

Open and Accepting

Tennessee

University of Tennessee Medical Center Cancer Institute

Knoxville, TN

Open and Accepting

Texas

MD Anderson Cancer Center The University of Texas

Houston, TX

Open and Accepting

Virginia

Virginia Commonwealth University Medical Center

Richmond, VA

Not Yet Accepting

Blue Ridge Cancer Care (Roanoke)

Roanoke, VA

Open and Accepting

Washington

Kadlec Clinic Hematology and Oncology

Kennewick, WA

Open and Accepting
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