A Phase 3, Open-label, Randomized Study to Compare the Efficacy and Safety of Luspatercept (ACE-536) vs Epoetin Alfa for the Treatment of Anemia Due to Revised International Prognostic Scoring System (IPSS-R) Very Low, Low, or Intermediate-Risk Myelodysplastic Syndrome (MDS) in Erythropoiesis-Stimulating Agent (ESA)-Naive Participants Who Are Non-Transfusion Dependent (NTD) ELEMENT-MDS
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What's the purpose of this trial?

The purpose of the study is to compare the efficacy and safety of Luspatercept vs epoetin alfa in the treatment of anemia in adults due to IPSS-R very low, low, intermediate-risk MDS in ESA-naïve participants who are non-transfusion dependent (NTD).

This trial is currently open and accepting patients.


What will happen during the trial?

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.

Inclusion Criteria:

* Participant has documented diagnosis of MDS according to World Health Organization (WHO) 2016 that meet IPSS-R classification of very low, low, or intermediate-risk disease, (intermediate-risk of ≤ 3.5 IPSS-R score) confirmed via bone marrow aspirate and: i) \< 5% blasts in bone marrow and \< 1% blasts in peripheral blood.
* Participant is not transfusion dependent (NTD) based on IWG2018 criteria
* Participant is erythropoiesis-stimulating agent naive. Participants may be randomized at the investigator's discretion if the participant received no more than 2 prior doses of epoetin alfa, epoetin alfa biosimilar, or darbepoetin alfa, with the last dose at least 8 weeks prior to randomization.
* Participant has a baseline endogenous serum erythropoietin (sEPO) level of ≤ 500 U/L.
* Participant has symptoms of anemia: i) Participant records a severity score of "moderate" or greater on at least 1 PGI-S item of fatigue, weakness, shortness of breath, or dizziness performed during the screening period.
* Participant has a baseline Hb concentration prior to randomization of ≤ 9.5 g/dL. The baseline Hb will be calculated using the mean of the two lowest available Hb measurements within 16 weeks prior to randomization and must include at least one central lab Hb reading done within the screening period (no more than 35 days before randomization). The two Hb measurements must have been performed at least seven days apart. Hb levels less than 21 days following RBC transfusion should not be used. Split samples for local assessments are not required.

Exclusion Criteria:

* Participant with secondary MDS (that is, MDS that is known to have arisen as the result of chemical injury or treatment with chemotherapy and/or radiation for other diseases).
* Participant with known history of diagnosis of AML.
* Participant with history of cerebrovascular accident (including ischemic, embolic, and hemorrhagic cerebrovascular accident), transient ischemic attack, deep venous thrombosis (including proximal and distal), pulmonary or arterial embolism, arterial thrombosis, or other venous thrombosis within 6 months prior to randomization.
* Participant with a history of pure red cell aplasia and/or antibody against erythropoietin.

Note: Other protocol-defined inclusion/exclusion criteria apply.


Additional Trial Information

Phase 3

Enrollment: 360 patients (estimated)

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Trial Links

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Trial Locations

All 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

Ventura County Hematology-Oncology Specialists

Oxnard, CA

Not Yet 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

Halifax Health Center for Oncology

Daytona Beach, FL

Not Yet Accepting

Florida Cancer Specialists - South - Fort Myers (Broadway)

Fort Myers, FL

Open and Accepting

Baptist MD Anderson

Jacksonville, 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

Illinois

Orchard Healthcare Research Inc. (Dr. Ira Oliff, MD)

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

Minnesota

Metro-Minnesota Community Oncology Research Consortium (MMCORC)

St. Louis Park, MN

Open and Accepting

Mississippi

Hattiesburg Clinic

Hattiesburg, MS

Open and Accepting

Ohio

Tennessee

Tennessee Oncology Memorial Plaza

Chattanooga, TN

Not Yet Accepting

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

Blue Ridge Cancer Care (Roanoke)

Roanoke, VA

Open and Accepting

Washington

Kadlec Clinic Hematology and Oncology

Kennewick, WA

Not Yet Accepting
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