Study on Bexmarilimab and Azacitidine Compared to Placebo and Azacitidine for Untreated Higher-Risk Myelodysplastic Syndromes

Inclusion Criteria

• Must provide written consent to participate.
• Must be 18 years or older.
• Must have a new diagnosis of higher-risk myelodysplastic syndromes (HR-MDS) as defined by the World Health Organization.
• Must have a specific risk classification and less than 20% abnormal cells in the bone marrow.
• Must be eligible and willing to start treatment with azacitidine.
• Must have a performance status score between 0 and 2, indicating good overall health.
• Must have a life expectancy of at least 3 months.
• Must have adequate organ function, including kidney and liver function.
• Must have a baseline white blood cell count below a certain level.
• Women of childbearing potential must have a negative pregnancy test and agree to use effective contraception during and after treatment.
• Must be willing and able to follow study procedures and attend follow-up visits.

Exclusion Criteria

• Have a previous diagnosis of acute myeloid leukemia (AML) or certain other blood disorders.
• Are candidates for immediate stem cell transplantation.
• Have more than 20% abnormal cells in the blood or bone marrow.
• Lack necessary genetic data or have a normal genetic profile with less than 5% abnormal cells.
• Have received previous treatments for MDS, except for supportive care.
• Have significant heart disease or recent heart attack.
• Have an active, uncontrolled infection or severe COVID-19 infection.
• Have active central nervous system involvement by the disease.
• Have had a stem cell transplant within the last 6 months or ongoing graft-versus-host disease.
• Have an active autoimmune disease requiring treatment.
• Have significant liver disease or abnormal liver function tests.
• Have received recent non-MDS related cancer treatments.
• Have another active or progressing cancer requiring treatment within the last 2 years.
• Have uncontrolled HIV, hepatitis B, or hepatitis C infections.
• Are pregnant or breastfeeding.
• Have previously been treated with bexmarilimab.
• Have any condition that would interfere with the study or its results.
• Have a history of severe allergic reactions to similar treatments.
• Have had major surgery within 4 weeks of starting the study.