Clinical Trial Goal
To find out if the combination of azacitidine, bleximenib and venetoclax is safe and works well to treat AML with KMT2A+ or NPM1+ mutations that has not yet been treated
You may be able to join this trial if you:
- Are 18 years old or older
- Have KMT2A+ or NPM1+ AML that has not yet been treated
- Do not have acute promyelocytic leukemia
- 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.
Bleximenib is a menin inhibitor that blocks KMT2A in 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 and the clinical trial doctors won’t know which group you’re in until after the trial is finished:
Bleximenib is a menin inhibitor that blocks KMT2A in 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 and the clinical trial doctors won’t know which group you’re in until after the trial is finished:
- Group 1 – Azacitidine plus bleximenib plus venetoclax
- Group 2 – Azacitidine plus placebo 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. The dose you'll get depends on when you start the trial and how safe it has been
- Bleximenib – Group 1 only - A pill that you take by mouth. The dose you'll get depends on when you start the trial and how safe it has been
- Venetoclax – A pill that you take by mouth. The dose you'll get depends on when you start the trial and how safe it has been
You may continue treatment for as long as the clinical trial doctors think it’s best for your health. You'll have biopsies to see how well the treatment is working. The clinical trial doctors will check your health for about 4 years.
The Food and Drug Administration (FDA) has not yet approved bleximenib.
Locations
Sponsors
lead: Janssen Research & Development, LLC
