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

Verified siteRegistered drugNo placebo
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What is this trial about?

A plain-language summary of the goals, design and what participants do

This clinical trial is focused on studying the treatment of Chronic Myeloid Leukemia (CML), a type of cancer that affects the blood and bone marrow. The study involves two treatments: Bosutinib, a medication taken orally, and Ropeginterferon Alfa-2B, which is given as an injection under the skin. The purpose of the study is to evaluate the effectiveness and safety of adding Ropeginterferon Alfa-2B to the treatment with Bosutinib from the time of diagnosis.

Participants in the study will receive either Bosutinib alone or in combination with Ropeginterferon Alfa-2B. The study will monitor the participants over a period to see how well the treatments work in achieving a deep molecular response, which means a significant reduction in cancer cells. The goal is to increase the number of patients who can eventually stop treatment and remain in remission, which is when the disease is not active.

The study will follow participants for several months, with regular check-ups to assess their response to the treatment and any side effects they may experience. The researchers aim to understand how these treatments can help manage Chronic Myeloid Leukemia and improve the quality of life for those affected by this condition.

The research process

The trial runs in 6 steps – from screening to follow-up. Each step says what happens and what the team monitors.

  1. Step 1

    Joining the study

    Upon joining the study, you will be required to sign a written informed consent form. This document confirms your understanding and agreement to participate in the trial.

  2. Step 2

    Initial treatment phase

    You will begin treatment with bosutinib, which is taken orally. The initial dosage is 300 mg daily. This phase lasts for three months.

    During this time, regular check-ups will be conducted to monitor your response to the medication and ensure you are tolerating it well.

  3. Step 3

    Evaluation for randomization

    After three months, your response to the treatment will be evaluated. This includes checking if you have achieved a complete hematologic response and if you can tolerate the bosutinib dosage.

    If eligible, you may be randomized to receive additional treatment with ropeginterferon alfa-2b.

  4. Step 4

    Randomized treatment phase

    If randomized, you will receive ropeginterferon alfa-2b as a subcutaneous injection. The dosage and frequency will be determined based on your specific needs and the study protocol.

    You will continue taking bosutinib alongside the new treatment.

  5. Step 5

    Ongoing monitoring

    Throughout the trial, regular assessments will be conducted to monitor your health and the effectiveness of the treatment. This includes blood tests and other evaluations at specified intervals.

    Your quality of life will also be assessed using questionnaires at key time points.

  6. Step 6

    End of trial participation

    The trial is expected to continue until December 31, 2030. Your participation may end earlier if you achieve certain health milestones or if it is in your best interest to discontinue.

    Upon completion, you will receive guidance on the next steps for your treatment and care.

Who can join the trial?

14 criteria

  • Must sign a written informed consent form before any study-related procedures.
  • Must be a man or woman aged between 18 and 75 years.
  • Must have been diagnosed with Chronic Myeloid Leukemia (CML) in the last 3 months.
  • Must have specific genetic markers called BCR-ABL transcripts.
  • Must not have received any treatment for CML except for hydroxyurea or anagrelide.
  • Must have an ECOG Performance Status of 2 or less, which means being able to carry out all self-care but unable to carry out any work activities.
  • Must have adequate organ function, including:
    • Total bilirubin less than 1.5 times the normal limit.
    • Liver enzymes (ASAT and ALAT) less than 2 times the normal limit.
    • Serum creatinine less than 1.5 times the normal limit.
    • Lipase less than 1.5 times the normal limit.
    • Women who can have children must use an effective method of birth control during the study.
    • Women who can have children must have a negative pregnancy test at the start of the study.
    • Must not be under guardianship or have any legal restrictions.
    • Must have health insurance coverage.

Who cannot join the trial?

9 criteria

  • Patients with any other type of cancer besides Chronic Myeloid Leukemia cannot participate.
  • Patients who are pregnant or breastfeeding are not eligible.
  • Patients with severe heart problems are excluded.
  • Patients with uncontrolled high blood pressure cannot join the study.
  • Patients with severe liver or kidney disease are not allowed to participate.
  • Patients who have had another investigational drug within the last 30 days are excluded.
  • Patients with a history of severe allergic reactions to the study drugs cannot participate.
  • Patients with active infections that require treatment are not eligible.
  • Patients with any other medical condition that the study doctors think would make it unsafe for them to participate are excluded.
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Investigated drugs

  • RoPegIFN

    is a long-acting medication used in this study to help treat patients with chronic myeloid leukemia. It is designed to work by boosting the body's immune system to fight the cancer cells more effectively. The goal of using RoPegIFN in this trial is to help patients achieve a deep molecular response, which means reducing the cancer cells in the body to very low levels. This could potentially allow patients to stop treatment in the future while keeping the cancer under control.

  • Bosutinib

    is another medication used in this study for treating chronic myeloid leukemia. It works by blocking certain proteins that cancer cells need to grow and multiply. By doing this, bosutinib helps to slow down or stop the progression of the disease. In this trial, bosutinib is used from the time of diagnosis to see how well it works in combination with RoPegIFN to improve patient outcomes.

What is already known about the treatment

  • Ropeginterferon

    Ropeginterferon is administered as an injection, typically under the skin, and is being studied for its effectiveness in treating chronic myeloid leukemia (CML). In medical literature, it is being evaluated for its potential to help patients achieve a deep molecular response, which may allow them to stop treatment eventually. The medication works by stimulating the immune system to attack cancer cells, helping to control the disease. It is classified as an interferon, a type of protein that plays a role in the immune response.

  • Bosutinib

    Bosutinib is taken orally in the form of a tablet and is currently used in the treatment of chronic myeloid leukemia (CML). It is well-established in medical practice and literature as a therapy for CML, particularly for patients who are newly diagnosed. Bosutinib works by inhibiting specific proteins that promote the growth of cancer cells, thereby slowing down or stopping the progression of the disease. It belongs to a class of drugs known as tyrosine kinase inhibitors, which target specific enzymes involved in cancer cell growth.

Investigated diseases

Chronic Myeloid Leukemia – Chronic Myeloid Leukemia is a type of cancer that affects the blood and bone marrow. It is characterized by the overproduction of immature white blood cells, known as myeloid cells. The disease progresses through three phases: chronic, accelerated, and blast crisis. In the chronic phase, symptoms may be mild or absent, and the disease progresses slowly. During the accelerated phase, the number of abnormal cells increases, leading to more noticeable symptoms. In the blast crisis phase, the disease behaves like an acute leukemia, with rapid progression and severe symptoms.
Trial detailsLast updated 7 Oct 2026
Age18+ yearsPhasePhase IITrial ID2024-517417-32-00Protocol codeBosuPegEstimated enrolment164 patientsSponsorSt. Olavs Hospital HF

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