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ANTIMETABOLITES

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.

Table of contents

Trial overview

The available trial data for ANTIMETABOLITES includes one interventional study in myelofibrosis.[1] The study compares current available therapies with imetelstat in patients whose disease is not responding to JAK-inhibitor treatment.[1]

Who is being studied

The target population is people with myelofibrosis who have intermediate-2 or high-risk disease.[1] 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.[1]

The study specifically includes participants who are not responding to JAK-inhibitor treatment.[1] This makes the trial relevant for patients with more advanced disease who still need better treatment options.[1]

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.[1] The study is interventional, so participants receive a study treatment or a comparison treatment as part of the research plan.[1]

The trial compares imetelstat with current available therapies, also called best available therapy in the study summary.[1] This comparison helps researchers see whether the study treatment performs better than usual care in this patient group.[1]

What is being measured

The main outcome is overall survival (OS).[1] Overall survival means the time from randomization until death from any cause.[1]

This endpoint is important because it shows whether one treatment helps people live longer than another treatment.[1] In this study, the main question is whether imetelstat improves survival compared with current available therapies in patients with difficult-to-treat myelofibrosis.[1]

Trial status and size

The study status is Authorised, meaning it has been approved to run according to the trial record.[1] The planned enrollment is 354 participants.[1]

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.[1] The trial data provided do not include detailed results, so the main focus is on the study design and its goal.[1]

Trial ID Phase Condition studied Status Enrollment
NCT04576156 Phase 3 Myelofibrosis Authorised 354

FAQ

  • What are the clinical trials about? The trial is comparing current available therapies with ANTIMETABOLITES in people with myelofibrosis. It is focused on whether the study treatment can improve overall survival compared with standard care.
  • Who may take part in the study? The study is for adults with intermediate-2 or high-risk myelofibrosis. Participants must have disease that is relapsed or refractory, meaning it has come back or is not responding, after JAK-inhibitor treatment.
  • What phase is the trial? This is a Phase 3 trial. Phase 3 studies usually compare a new treatment with current treatment in a larger group of people.
  • What is the trial measuring? The main endpoint is overall survival. This means the study measures the time from randomization to death from any cause.
  • How many people are planned for the study? The planned enrollment is 354 participants. This helps researchers compare outcomes in a larger group.

Ongoing Clinical Trials on ANTIMETABOLITES

  • Study of Imetelstat Compared to Drug Combination for Treating Intermediate-2 or High-Risk Myelofibrosis in Patients Not Responding to JAK-Inhibitor Treatment

    Not recruiting

    3 1 1 1
    Investigated drugs:
    Austria Belgium Bulgaria Denmark France Germany +5

Glossary

  • Myelofibrosis: A serious bone marrow disease that can affect how blood cells are made.
  • Intermediate-2 risk: A risk level used to describe more advanced disease with a greater need for treatment.
  • High-risk: A higher disease risk group, often linked with worse expected outcomes.
  • JAK-inhibitor treatment: A type of treatment used before this trial. In this study, the disease is not responding well to it.
  • Relapsed: The disease has come back after improving for a time.
  • Refractory: The disease is not responding to treatment.
  • Phase 3: A late-stage clinical trial that compares treatments in a larger group of patients.
  • Randomization: A process where participants are assigned to treatment groups by chance.
  • Overall survival: The length of time a person lives after starting the study treatment.
  • Standard care: The usual treatment available outside the trial.

References