ALKYLATING AGENTS

Clinical trials investigating ALKYLATING AGENTS are studying treatment options for people with myelofibrosis, especially those with intermediate-2 or high-risk disease. The main goal is to compare outcomes such as overall survival and see how well current treatment choices work in patients whose disease is not responding to JAK-inhibitor treatment.

Table of Contents

Trial overview

The provided trial data include one authorised interventional study, which means researchers assign treatments and then measure the results in patients.[1] The study is in myelofibrosis, a blood cancer that affects the bone marrow and can cause serious illness.[1]

The trial title says it compares current available therapies with imetelstat for people with intermediate-2 or high-risk myelofibrosis who are not responding to JAK-inhibitor treatment.[1] The brief summary says the main goal is to compare overall survival in people with relapsed or refractory disease.[1]

Who is being studied

This study is for people with intermediate-2 or high-risk myelofibrosis.[1] These risk groups describe more serious disease, so the trial focuses on patients who may need stronger treatment options.[1]

The study also includes patients whose disease is relapsed or refractory after JAK-inhibitor treatment.[1] Relapsed means the disease has returned, and refractory means it is not responding to treatment.[1]

What the study compares

The trial compares current available therapies with imetelstat.[1] This kind of comparison helps researchers see whether one treatment approach leads to better outcomes than the other.[1]

The intervention list shows imetelstat given intravenously, which means through a vein.[1] The data do not provide further details about the other treatment options, only that they are current available therapies.[1]

Study phase and size

This is a Phase 3 trial.[1] Phase 3 studies are later-stage trials that usually compare treatments in a larger group of patients.[1]

The planned enrollment is 354 participants.[1] A study of this size can help researchers compare results more reliably across treatment groups.[1]

Main endpoint

The primary outcome is overall survival.[1] Overall survival means the time from randomization to death from any cause.[1]

This endpoint is important because it shows whether one treatment strategy helps people live longer than another.[1] In this study, researchers are using overall survival to judge the main benefit of treatment.[1]

What the results may mean for patients

From the trial data, the main question is whether the study treatment approach can improve survival for people with difficult-to-treat myelofibrosis.[1] The study is focused on patients whose disease has not responded well to JAK-inhibitor treatment, so it targets a group with limited options.[1]

The trial is authorised, which means it has been approved to move forward.[1] Because the study is still a clinical trial, its purpose is to test and compare outcomes rather than to give a final answer about treatment success.[1]

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

Ongoing Clinical Trials on ALKYLATING AGENTS

  • 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
    Austria Belgium Bulgaria Denmark France Germany +5

Glossary

  • Myelofibrosis: A type of blood cancer that affects the bone marrow, where blood cells are made.
  • Intermediate-2 risk: A disease risk group that shows a more serious form of illness than lower-risk disease.
  • High-risk: A group used to describe disease that is more severe and may need more urgent treatment.
  • JAK-inhibitor treatment: A treatment approach that works on a specific pathway used in myelofibrosis. In this trial, patients are not responding well to it.
  • Relapsed: When a disease returns after treatment.
  • Refractory: When a disease does not respond to treatment.
  • Phase 3: A later stage of clinical research that usually compares treatments in a larger group of patients.
  • Overall survival: The length of time people live after a treatment starts or after randomization in a study.
  • Randomization: A process where participants are assigned to treatment groups by chance.
  • Current available therapies: The treatments already available to patients and used as the comparison group in the study.
  • Interventional study: A study in which researchers assign a treatment to see how it affects health outcomes.

References