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

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What is this study about?

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.

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 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 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 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 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 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 Study?

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 Study?

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.

Where you can join this trial?

Verified and Recommended Sites

No sites found in this category

Verified Sites

Site Name	City	Country	Status
Oslo Universitetssykehus HF	Oslo	Norway

Other Sites

Site Name	City	Country
Region Oerebro Laen	Orebro	Sweden
St. Olavs Hospital HF	Trondheim	Norway
Helse Stavanger HF	Stavanger	Norway
Region Norrbotten	Lulea	Sweden
Lund University Hospital	Lund	Sweden
Odense University Hospital	Odense	Denmark
Karolinska University Hospital	Solna	Sweden
Aalborg University Hospital	Aalborg	Denmark
Rigshospitalet	Copenhagen	Denmark
Queen Silvia Childrens Hospital – Sahlgrenska University Hospital – Vaestra Goetalandsregionen	Gothenburg	Sweden
Region Sjaelland	Holbæk	Denmark
Udicqox Umfaiyudsg Hbyabcgj	Uppsala	Sweden
Heiba Byayxk Hs	Bergen	Norway
Hdewpibf Ubwtehophu Crzdeib Hbgtghsg	Helsinki	Finland
Avylox Uatwkykywr Hmjhvtmg	Aarhus	Denmark
Rgwlrw Sclbaepmyt	Vejle	Denmark

Trial status

Country	Status	Recruitment Start
Denmark	Not recruiting	29.04.2019
Finland	Not recruiting	29.04.2019
Norway	Not recruiting	29.04.2019
Sweden	Not recruiting	29.04.2019

Trial locations

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.

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 ID:

2024-517417-32-00

Protocol code:

BosuPeg

NCT ID:

NCT03831776

Trial Phase:

Therapeutic exploratory (Phase II)

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

What is this study about?

Who Can Join the Study?

Who Cannot Join the Study?