Clinical Trial Goal
To find out if elritercept is safe and works well to treat anemia in transfusion dependent MDS, compared to epoetin alfa
You may be able to join this trial if you:
- Are 18 years old or older
- Have MDS that doctors consider to be very low, low or intermediate-risk
- Received 2-6 units of red blood cell transfusions in the last 2 months
- Have not been treated with any of the following (your doctor can tell you this):
- Blood or marrow transplant (BMT)
- Darbepoetin
- Epoetin alfa
- Elritercept
- Granulocyte colony-stimulating factor (G-CSF)
- Hypomethylating agents (HMA)
- Imetelstat
- Luspatercept
- Sotatercept
- Agree to have other standard tests done to see if you can be in the clinical trial
Trial Details
Elritercept is a protein that helps the body produce more red blood cells and platelets.
Epoetin alfa is a type of protein that tells your bone marrow to produce more red blood cells.
In this trial, you’ll be randomized to 1 of 2 groups. Once you’re randomized, you’ll be told what group you’re in:
Epoetin alfa is a type of protein that tells your bone marrow to produce more red blood cells.
In this trial, you’ll be randomized to 1 of 2 groups. Once you’re randomized, you’ll be told what group you’re in:
- Group 1 – Elritercept
- Group 2 – Epoetin alfa
Randomized means doctors will use a computer to assign you to either group. A computer assigns you by chance, like flipping a coin or drawing a name out of a hat. You, your doctor or the clinical trial doctor won’t have any control over which group you’ll be assigned. This means you won’t be able to choose your group.
You’ll get treatment in cycles that last 1 month. In each cycle, you'll get:
- Elritercept – Group 1 only - Given as a shot under your skin 1 time
- Epoetin alfa – Group 2 only - Given as a shot under your skin 1 time each week
You'll have blood tests to see how well the treatment is working. The clinical trial doctors will check your health for about 5 years.
The Food and Drug Administration (FDA) has not yet approved elritercept.
Locations
Sponsors
lead: Takeda
