A Study to Investigate APL-4098 Alone and in Combination in Adults With AML or MDS

To join this study, you must be 18 years old or older. You should have a confirmed diagnosis of certain types of Acute Myeloid Leukaemia (AML) or Myelodysplastic Syndrome (MDS). This includes situations where your AML has come back or isn't responding to treatment, or if you have MDS that has turned into AML or has a high number of abnormal cells (MDS-EB). Importantly, you must either be unable to take, or be considered unsuitable for, other treatments that are known to help your condition.

There are also some health checks you need to pass. For example, your white blood cell count needs to be below a certain level, and you should generally be well enough to take part in daily activities without too much difficulty. Your weight must be at least 40 kg. If you are a woman who could become pregnant, you'll need a negative pregnancy test and agree not to become pregnant or breastfeed during the study. Both men and women will need to use effective contraception if they are sexually active.

On the other hand, there are reasons you might not be able to join. These include having recently had certain types of stem cell transplants or other cancer treatments. You also wouldn't be able to join if you have certain other serious medical conditions like a recent heart attack, uncontrolled infections, or severe heart failure. Some blood test results or findings from scans (like heart function) would also need to be within a specific range. People with HIV or active Hepatitis B or C would also not be able to take part.

If you decide to take part in this study, you would first go through a screening period to make sure you meet all the requirements. This would involve medical checks, blood tests, and potentially other scans. Once enrolled, you would receive the study medication (APL-4098, either alone or with other drugs) according to a specific schedule, which would involve regular visits to the clinic. At these visits, doctors would monitor your health carefully, perform physical exams, take blood samples, and ask about any side effects you might be experiencing. The exact number of visits and tests would depend on the treatment plan you are on. You would continue to receive treatment for as long as deemed beneficial by your doctors or until any reasons for stopping arise. Even after stopping treatment, there will be follow-up appointments to check on your long-term health. The total duration of your participation, including follow-up, will be explained by the study team.