Study to Evaluate Imetelstat in Patients With High-Risk MDS or AML Failing HMA-based Therapy

To join this study, you must be at least 18 years old. You need to have been diagnosed with either AML or MDS based on specific medical criteria. A key requirement is that your previous standard treatments (like azacitidine or decitabine, alone or with venetoclax) either haven't worked, stopped working, or you couldn't tolerate them due to side effects. You also need to have at least 5% abnormal cells (blasts) in your bone marrow.

It's important that you are not suitable for a bone marrow transplant from another person. Certain blood test results must fall within specific ranges, and your overall physical well-being, as assessed by doctors, needs to be at a level that allows you to participate safely. You also can't be on other AML/MDS treatments (except for certain blood cell growth factors) for at least 14 days before starting the study.

Women who could become pregnant must use a highly effective form of birth control while in the study. All participants must be able to follow the study schedule, including attending all planned appointments and following all study instructions.

If you decide to take part in this study, you'll first go through a screening process to make sure you meet all the requirements. This will involve physical exams, blood tests, and other health checks. If you're eligible, you'll start receiving the study drug, imetelstat sodium. The study drug will be given regularly, and you'll have specific appointments for hospital visits, blood tests, and examinations to see how you're responding and to check for any side effects. These visits will help doctors monitor your progress. If the treatment is helping and you're tolerating it well, you may continue taking imetelstat until your condition progresses or you can no longer tolerate the treatment. The total duration of your participation will depend on how you respond to the treatment.