A Study of Bleximenib, Venetoclax and Azacitidine For Treatment of Participants With Newly Diagnosed Acute Myeloid Leukemia (AML)

This study is for adults aged 18 or over who have been recently diagnosed with Acute Myeloid Leukemia (AML). You would need to have certain genetic changes in your AML cells, specifically in the NPM1 or KMT2A genes.

Critically, this study is for people who are not suitable for standard, strong chemotherapy. This might be because you are aged 75 or older, or if you are younger but have other health issues like certain heart or lung conditions, kidney problems, or other medical issues that make intensive chemotherapy too risky. Your medical team would make this decision along with you.

There are also some reasons why you wouldn't be able to join, such as if you have a different specific type of leukaemia (called APL), if your leukaemia has spread to your brain or spinal cord, or if you've had an organ transplant in the past.

If you decide to take part in this study, you would first undergo a thorough health check to make sure the study is right for you. If you are eligible, you would be assigned to one of several treatment groups. This could involve receiving the experimental drug bleximenib, or the standard combination of Venetoclax and Azacitidine, or a dummy drug (placebo) along with Venetoclax and Azacitidine.

You would have regular appointments at the hospital, which would include blood tests, bone marrow checks, and other assessments to monitor your health and how the treatment is working. It's important to note that you would need to use specific contraception if you are a woman of childbearing age or a man, for a set period during and after the study treatment. The exact number of visits and the duration of your participation would be explained in detail by the study team, but typically, clinical trials involve ongoing monitoring and follow-up for a period after the main treatment phase.