Clinical Trial Goal
To find out if the combination of azacitidine, cusatuzumab and venetoclax is safe and works well to treat AML that has not yet been treated
You may be able to join this trial if you:
- Are 18 years old or older
- Have AML and have had little to no treatment
- Are not eligible for intensive chemotherapy (chemo)
- Agree to have other standard tests done to see if you can be in the clinical trial
Trial Details
Azacitidine is a drug that blocks the growth of cancer cells.
Cusatuzumab is a monoclonal antibody that targets CD70 on certain cells
Venetoclax is a small molecule inhibitor that blocks BCL2 in certain 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:
Cusatuzumab is a monoclonal antibody that targets CD70 on certain cells
Venetoclax is a small molecule inhibitor that blocks BCL2 in certain 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 – Azacitidine plus Cusatuzumab plus venetoclax
- Group 2 – Azacitidine plus venetoclax
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:
- Azacitidine – Given as intravenous (IV) infusions or as a shot under your skin 1 time each day
- Cusatuzumab – Group 1 only - Given as IV infusions 2 times
- Venetoclx - A pill that you take by mouth 1 time each day
You'll have biopsies to see how well the treatment is working. The clinical trial doctors will check your health for up to 5 years.
The Food and Drug Administration (FDA) has not yet approved cusatuzumab.
Locations
Sponsors
lead: OncoVerity, Inc.
