A Study of Revumenib in R/R Leukemias Including Those With an MLL/KMT2A Gene Rearrangement or NPM1 Mutation

To be considered for this study, you must have active acute leukaemia that has either come back or not responded to previous treatments. Your bone marrow or blood must show signs of the leukaemia.

The study is particularly looking for people with certain genetic changes in their leukaemia, like those involving the KMT2A or NPM1 genes. Your doctor will be able to check for these specific changes. Your white blood cell count also needs to be below a certain level (25,000 per microliter) when you start the study, though doctors can help reduce it if needed before you join.

During the first stage of the study, depending on whether you are taking certain other medicines (like some antifungals such as itraconazole or fluconazole) or a specific helper medicine called cobicistat, you might be placed into different groups. Your medical team will guide you on these specific requirements.

Taking part in this study would involve regular visits to the hospital for checks and to receive your medication. During these visits, doctors will closely monitor your health, take blood and bone marrow samples to see how the leukaemia is responding, and check for any side effects. You will be taking the study medicine, revumenib, by mouth. Depending on which part of the study you're in, you might also take other medicines alongside it, such as cobicistat or certain antifungal medications.

The exact number of visits and the full duration of your participation will depend on how you respond to the treatment and the stage of the study you are in. Initially, there will be more frequent check-ups, and if the treatment is working well, follow-up visits might become less frequent over time. The study aims to understand both the short and long-term effects of revumenib.