Ongoing, recruitingTherapeutic exploratory (Phase II)Interventional

A phase 2, multi-center, open-label, randomized study of oral asciminib added to imatinib versus continued imatinib versus switch to nilotinib in patients with CML-CP who have been previously treated with imatinib and have not achieved deep molecular response

This research study is for people with a type of blood cancer called Chronic Myeloid Leukaemia (CML) who have already been treated with a medicine called imatinib, but whose cancer cells are still detectable, even if at a low level. The study aims to find out if adding a new drug, asciminib (also known as Scemblix), to imatinib, or switching to it, or switching to another existing drug called nilotinib, can help people achieve better control of their CML. This means trying to get to a point where the number of cancer cells in the body is very low – sometimes called a 'deep molecular response'. We will be comparing these different treatment approaches to see which one is most effective over 48 and 96 weeks. It's a key step in helping doctors understand the best ways to treat CML when initial treatments haven't fully worked.

At a glance

Status

Ongoing, recruiting

Phase

Therapeutic exploratory (Phase II)

Sponsor

Novartis Pharma AG

Enrolment target

Start

20 Sep 2024

Chronic Myelogenous Leukemia in chronic phase (CML-CP)previously treated with imatinib and have not achieved deep molecular response

What is this study about?

This clinical trial is designed for people who have Chronic Myeloid Leukaemia (CML). CML is a type of cancer that affects the blood and bone marrow. Normally, doctors treat CML using medicines like imatinib. However, for some people, imatinib doesn't fully reduce the number of cancer cells to a very low level, even if they are otherwise feeling well. This study is for those individuals.

The main purpose of this study is to compare different treatment strategies to see which one works best. Participants will be randomly assigned to one of three groups. One group will continue with imatinib but have a new medicine called asciminib (Scemblix) added to it. Another group will stop imatinib and switch to asciminib. The third group will stop imatinib and switch to nilotinib, which is another established CML treatment. Researchers want to see if these new approaches can help more people achieve a 'deep molecular response', which means significantly reducing the number of CML cells in their body, for a longer period.

Throughout the study, doctors will closely monitor participants' health and the levels of CML cells in their blood. They'll be looking at how well the treatments work over 48 and 96 weeks, any side effects that might occur, and how the body handles the study medicines. The information gathered from this study will help doctors make better decisions about how to treat CML in the future, especially for patients whose first treatment hasn't managed to get their CML under very good control.

Key takeaways

Study for CML patients whose imatinib treatment hasn't fully worked.
Compares asciminib (Scemblix) with existing CML drugs.
Aims to find treatments that lead to a 'deep molecular response' (very low cancer cells).
Participation involves taking daily tablets and regular hospital visits for two years.
You will be randomly assigned to one of three treatment groups.
You can stop participating at any time.

Who may be eligible?

To join this study, you need to be an adult, aged 18 years or older, with no upper age limit. You would have been diagnosed with a type of blood cancer called Chronic Myeloid Leukaemia (CML), specifically in its 'chronic phase' – which means it's not an aggressive or advanced stage of the disease.

Crucially, you would have already been treated with a medicine called imatinib for your CML. Even though you've been on imatinib, tests would show that your CML hasn't fully gone into a 'deep molecular response'. This means some CML cells are still detectable in your body, although you might be feeling perfectly fine. Both men and women can take part in this study.

Quick self-check

Are you 18 years old or older?
Do you have Chronic Myeloid Leukaemia (CML) in its chronic, or early, phase?
Have you been treated with imatinib for your CML?
Do your latest blood tests show that your CML hasn't reached a 'deep molecular response' (meaning some CML cells are still detectable)?

This is a guide only — the research team will confirm whether you can take part.

What does participation involve?

If you decide to join this study, you'll be randomly assigned to one of three treatment groups, similar to drawing straws, so neither you nor your doctor can choose which group you're in. You'll take your study medication (either asciminib plus imatinib, asciminib alone, or nilotinib) by mouth as tablets. The study will involve regular visits to the hospital or clinic over a period of 96 weeks (about 2 years).

During these visits, which will likely be more frequent at the beginning and then spread out, you'll have blood tests to check your CML levels and monitor your general health. You'll also have physical examinations, and your doctor will ask you about any side effects you might be experiencing. We will also check your heart with an ECG (electrocardiogram) and measure your vital signs like blood pressure and pulse. The exact number of visits and tests will be explained to you in detail by the study team, but throughout the nearly two years, your health will be carefully watched and supported.

Potential risks and benefits

Taking part in a clinical trial offers the chance to try new treatments that aren't yet widely available, which might be more effective for your CML. The close monitoring you'll receive could also be considered a benefit. However, like all medicines, the study drugs can have side effects, some of which could be serious or unexpected. You may also experience side effects that make you feel unwell, or the treatment might not work for you. There will also be a time commitment involved with the regular clinic visits. It's very important to remember that participating is completely voluntary, and you can change your mind and withdraw from the study at any time, for any reason, without it affecting your usual medical care.

Locations (5)

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France
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Spain
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Italy
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Czechia
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Austria

Common questions

What is 'Chronic Myeloid Leukaemia (CML) in chronic phase'?

CML is a slow-growing cancer of the blood and bone marrow. 'Chronic phase' means it's the early, less aggressive stage of the disease.

What does 'not achieved deep molecular response' mean?

It means that even after treatment, blood tests still show a detectable, though often low, number of CML cancer cells in your body.

What is asciminib (Scemblix)?

Asciminib is a new type of medicine being studied for CML. It works in a different way to some existing CML drugs.

Will I definitely get the new drug, Scemblix?

Not necessarily. You will be randomly assigned to one of three groups: one gets Scemblix plus imatinib, another gets Scemblix alone, and the third gets nilotinib.

How long will I be in the study?

The main part of the study where you receive treatment and are closely monitored lasts for 96 weeks, which is about two years.