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Ropeginterferon Alfa-2B

Clinical trials are investigating Ropeginterferon Alfa-2B in blood cancers and related blood disorders. These studies look at how well it works, how safe it is, and whether it improves disease control in adults with essential thrombocythaemia or chronic myeloid leukemia.

Table of contents

Clinical trials overview

These studies are interventional trials, which means researchers give a treatment and then measure the results.[1][2] They are studying Ropeginterferon Alfa-2B in two different blood diseases: essential thrombocythaemia and chronic myeloid leukemia.[1][2]

Both trials are listed as Authorised and are being done in adults with specific disease settings.[1][2] The main question in each study is whether Ropeginterferon Alfa-2B improves disease control and is safe enough for the target group.[1][2]

Essential thrombocythaemia trial

The Phase 3 study in essential thrombocythaemia is a multicenter trial, meaning it is run at more than one study site.[1] It plans to enroll 132 people.[1]

This study is designed to estimate disease response rates according to modified ELN criteria, which are rules used to define how well the disease is controlled.[1] The trial focuses on patients who are intolerant to, refractory to, or not eligible for other cytoreductive treatments.[1]

The trial title and summary show that the study is looking at efficacy and safety of Ropeginterferon Alfa-2B in this patient group.[1]

Chronic myeloid leukemia trial

The Phase 2 BosuPeg trial studies Ropeginterferon Alfa-2B in chronic myeloid leukemia patients who are treated with bosutinib from diagnosis.[2] It plans to enroll 164 people.[2]

This study is randomized and prospective, which means people are assigned to treatment groups by chance and then followed forward in time.[2] The study compares bosutinib alone with bosutinib plus Ropeginterferon Alfa-2B.[2]

The goal is to see whether adding Ropeginterferon Alfa-2B improves deep molecular response and may help more patients reach treatment-free remission.[2]

What the trials measure

In the essential thrombocythaemia study, the main outcome is the rate of disease response at month 12 using modified ELN criteria.[1] This includes durable blood count remission, no hemorrhagic or thrombotic events, no disease progression, no worsening of disease-related signs, and lasting improvement or stability in symptoms measured by the MPN-SAF TSS.[1]

In simple terms, the study asks whether blood counts improve, symptoms stay controlled, and serious disease problems do not appear.[1]

In the chronic myeloid leukemia study, the main outcome is the rate of molecular response 4 at 12 months in each treatment arm.[2] A molecular response is a very deep response measured by disease markers in the blood.[2]

This trial also looks at whether the combination treatment can increase the chance of treatment-free remission.[2]

Who may take part

The essential thrombocythaemia trial is for patients who are intolerant to, refractory to, or not eligible for other cytoreductive treatments.[1] These terms mean that previous treatment did not work well, caused problems, or was not suitable for the patient.[1]

The chronic myeloid leukemia trial is for patients treated with bosutinib from diagnosis.[2] The trial does not give more details in the source data about other eligibility rules.[2]

Trial design and phases

The essential thrombocythaemia study is Phase 3, which usually means a larger study that helps confirm treatment benefit in a broader group of patients.[1] The chronic myeloid leukemia study is Phase 2, which usually looks for early signs of benefit and continues to assess safety.[2]

Both studies are interventional, so the treatment is actively given and then measured against study goals.[1][2] Together, these trials show that Ropeginterferon Alfa-2B is being studied in different blood cancers with different treatment strategies and outcome measures.[1][2]

Trial ID Phase Condition studied Status Enrollment
2023-505160-12-00 Phase 3 Essential Thrombocythaemia Authorised 132
NCT03831776 Phase 2 Chronic Myeloid Leukemia Authorised 164

FAQ

  • What conditions are being studied with Ropeginterferon Alfa-2B? The trials in this article study essential thrombocythaemia and chronic myeloid leukemia. Both are blood diseases, but they are different conditions with different treatment goals.
  • What phases are the Ropeginterferon Alfa-2B trials in? One study is Phase 3 and one study is Phase 2. Phase 2 studies usually look at early signs of benefit, while Phase 3 studies compare treatment effects in a larger group.
  • Who may take part in these trials? The essential thrombocythaemia study is for patients who are intolerant to, refractory to, or not eligible for other cytoreductive treatments. The chronic myeloid leukemia study is for patients treated with bosutinib from diagnosis.
  • What are the trials trying to measure? The studies measure treatment response, including blood count control and molecular response. They also look at safety and whether the disease stays stable without progression.
  • How many people are enrolled in these studies? The essential thrombocythaemia trial plans to enroll 132 people. The chronic myeloid leukemia trial plans to enroll 164 people.

Ongoing Clinical Trials on Ropeginterferon Alfa-2B

  • Study on the Effectiveness and Safety of Ropeginterferon and Bosutinib for Patients with Chronic Myeloid Leukemia

    Not recruiting

    1 1 1
    Investigated drugs:
    Denmark Finland Norway Sweden

  • Study on Ropeginterferon Alfa-2b for Patients with Essential Thrombocythemia Intolerant or Refractory to Other Treatments

    Not recruiting

    1 1 1 1
    Investigated diseases:
    Investigated drugs:
    Austria Czechia France Germany Greece Hungary +4

Glossary

  • Essential thrombocythaemia: A blood disorder where the body makes too many platelets, which can raise the risk of clotting or bleeding.
  • Chronic myeloid leukemia: A type of blood cancer that starts in the bone marrow and often develops slowly.
  • Phase 2: A trial phase that checks whether a treatment shows signs of benefit and continues to study safety.
  • Phase 3: A larger trial phase that compares how well a treatment works and how safe it is in more people.
  • Interventional study: A study where researchers give a treatment and then measure the results.
  • Efficacy: How well a treatment works.
  • Safety: How well a treatment is tolerated and whether it causes problems.
  • Disease response: Signs that the disease is improving or being controlled.
  • Molecular response: A deep treatment response measured by very small amounts of disease markers in the blood.
  • Cytoreductive treatment: Treatment used to lower the number of blood cells made by the body.
  • Disease progression: When a disease gets worse over time.
  • Treatment-free remission: A period when the disease stays controlled even without ongoing treatment.

References