(Apex) Bezuclastinib in Patients With Advanced Systemic Mastocytosis

To join this study, you need to be an adult (18 years or older) and have one of the more advanced forms of mastocytosis (aggressive systemic mastocytosis, mastocytosis with another blood cancer, or mast cell leukemia). Doctors will need to confirm your diagnosis. You also need to have signs of the disease that can be measured, and your general health, including your heart, should be stable enough to take part. Your recent blood test results also need to be within certain acceptable ranges.

There are also reasons why you might not be able to join. For example, if you still have serious side effects from previous mastocytosis treatments, or if you need immediate treatment for another blood cancer. You can't have certain heart conditions or have had serious bleeding recently. If you have HIV, Hepatitis B, or Hepatitis C, or certain other cancers, you wouldn't be able to participate. Also, if you've recently had other cancer treatments, certain medications, or specific types of growth factors, you might need to wait before joining.

If you decide to take part in this study, you will be given the study medicine, bezuclastinib. The study is open-label, meaning everyone will know you are taking the study drug. You will have regular visits to the clinic so the study team can monitor your health, check how the medicine is working, and look for any side effects. This will involve regular blood tests, physical examinations, and possibly other tests to see how your mastocytosis is responding to the treatment. You might also be asked to complete questionnaires about how you are feeling.

The total duration of your participation in the study will depend on how you respond to the treatment and the study’s protocol. There will be an initial treatment period, followed by ongoing monitoring. You will be able to stop participating in the study at any time if you wish to, for any reason, without it affecting your usual medical care.