In short
Clinical trials investigating "ANTIMETABOLITES" are looking at treatment results in people with myelofibrosis, especially those with intermediate-2 or high-risk disease. The main goal is to compare safety and effectiveness, including overall survival, in patients whose disease is not responding to JAK-inhibitor treatment.
Key points
- Clinical trials investigating "ANTIMETABOLITES" are studying people with myelofibrosis, a blood and bone marrow disease. The main trial is a Phase 3 study in patients with intermediate-2 or high-risk disease that is relapsed or refractory after JAK-inhibitor treatment. Researchers are comparing the study treatment with current available therapies. The key endpoint is overall survival, which measures how long participants live after randomization. The planned enrollment is 354 people.
Trial overview
The available trial data for ANTIMETABOLITES includes one interventional study in myelofibrosis. The study compares current available therapies with imetelstat in patients whose disease is not responding to JAK-inhibitor treatment.
Who is being studied
The target population is people with myelofibrosis who have intermediate-2 or high-risk disease. The trial is also focused on patients with relapsed or refractory disease, which means the disease has come back or is not improving with treatment.
The study specifically includes participants who are not responding to JAK-inhibitor treatment. This makes the trial relevant for patients with more advanced disease who still need better treatment options.
Trial design and phase
This is a Phase 3 clinical trial, which means it is a late-stage study that compares treatments in a larger group of people. The study is interventional, so participants receive a study treatment or a comparison treatment as part of the research plan.
The trial compares imetelstat with current available therapies, also called best available therapy in the study summary. This comparison helps researchers see whether the study treatment performs better than usual care in this patient group.
What is being measured
The main outcome is overall survival (OS). Overall survival means the time from randomization until death from any cause.
This endpoint is important because it shows whether one treatment helps people live longer than another treatment. In this study, the main question is whether imetelstat improves survival compared with current available therapies in patients with difficult-to-treat myelofibrosis.
Trial status and size
The study status is Authorised, meaning it has been approved to run according to the trial record. The planned enrollment is 354 participants.
One trial is listed in the available data, so the evidence here is focused on a single Phase 3 study rather than a large group of different trials. The trial data provided do not include detailed results, so the main focus is on the study design and its goal.