Phase 2b Clinical Trial Evaluating Bexmarilimab + Azacitidine Versus Placebo + Azacitidine in Participants with Treatment Naïve Higher Risk Myelodysplastic Syndrome BEXERA

What's the purpose of this trial?

The goal of this clinical trial is to determine which dose of bexmarilimab given in combination with azacitidine is safest and most effective at treating high risk myelodysplastic syndrome.

This is an upcoming trial that has not yet started accepting patients.

What will happen during the trial?

This trial is organized into three different groups, or arms. Participants will be randomly assigned into one of the three arms. Participants in all arms will receive treatment in 28 day cycles. Depending on the arm they are randomized into, participants will either receive bexmarilimab in combination with azacitidine or a placebo in combination with azacitidine. 


This clinical trial is a double-blind clinical trial. This means that participants, investigators and study teams will not know whether or not a participant is receiving bexmarilimab or a placebo. All participants in this study will receive azacitidine. 


Participants in this study may continue to receive trial therapy for a maximum of 36 months after the first dose. Participants may be removed from the study sooner if their MDS worsens, they experience bad side effects, or decide to stop participating.

 

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 newly diagnosed moderately high, high or very high risk myelodysplastic syndrome
  • are not considered a candidate for an allogeneic stem cell transplant at the time of screening.
  • do not have greater than 20% blasts in peripheral blood or bone marrow.
    have not previously received treatment for MDS including hypomethylating agents, chemotherapy, or transplant. Treatment with growth factors or transfusions is allowed.
  • have not previously had treatment with bexmarilimab.
  • have adequate major organ function as described by the protocol criteria.

Additional Trial Information

Phase 2

Enrollment: 90 patients (estimated)

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Trial Locations

All Trial Locations

View all clinical trial locations sorted by state.

California

City of Hope Comprehensive Cancer Center Beckman Research Institute

Duarte, CA

Not Yet Accepting

Colorado

University of Colorado Cancer Center Anschutz Cancer Pavilion

Aurora, CO

Not Yet Accepting

Connecticut

Smilow Cancer Hospital at Yale New Haven

New Haven, CT

Not Yet Accepting

Florida

Moffitt Cancer Center Magnolia Campus

Tampa, FL

Not Yet Accepting

Massachusetts

Massachusetts General Hospital

Boston, MA

Not Yet Accepting

North Carolina

UNC Lineberger Comprehensive Cancer Center University of North Carolina

Chapel Hill, NC

Not Yet Accepting

Tennessee

Vanderbilt-Ingram Cancer Center Henry-Joyce Cancer Clinic

Nashville, TN

Not Yet Accepting

Texas

MD Anderson Cancer Center The University of Texas

Houston, TX

Not Yet Accepting

Wisconsin

Medical College of Wisconsin Froedtert Hospital

Milwaukee, WI

Not Yet Accepting
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