AuthorisedTherapeutic exploratory (Phase II)Interventional

Safety and efficacy of treatment combination with ponatinib and asciminib in chronic myeloid leukemia patients resistant to ponatinib and/or asciminib

This research study is investigating a new way to treat chronic myeloid leukemia (CML), a type of blood cancer. It focuses on patients whose current treatments, specifically Scemblix or Iclusig, are no longer as effective. The study wants to find out if using both Scemblix and Iclusig together is a safe and helpful new option. Researchers will be carefully monitoring how the body responds to this drug combination and looking for signs that the treatment is reducing the number of cancer cells. They will also track any side effects to understand how well patients tolerate the combined therapy. The goal is to provide a better treatment choice for people living with CML who need different options.

At a glance

Status

Authorised

Phase

Therapeutic exploratory (Phase II)

Sponsor

Grupo Espanol De Leucemia Mieloide Cronica (GELMC)

Enrolment target

Start

01 Jun 2026

Chronic Myeloid Leukemia

What is this study about?

Chronic myeloid leukemia (CML) is a type of cancer that affects the blood and bone marrow. While there are good treatments available, sometimes these treatments might not work as well over time, or patients might develop resistance to them. This study is designed for those individuals.

The research looks at using two medicines, Scemblix and Iclusig, together. Both of these medicines are already approved and used to treat CML. However, this study is exploring a new approach: combining them for patients whose CML isn't responding adequately to either medicine alone. The main aim is to see if this combination can lead to a significant reduction in CML cells in the body, which is a key sign the treatment is working well. Researchers will check this after six months.

Beyond just seeing if the treatment works, the study will also pay close attention to safety. They want to understand any side effects patients might experience, how often they occur, and how severe they are. This helps doctors know what to expect and how to best manage the treatment. Ultimately, the goal is to find better and safer ways to help people with CML live healthier lives.

Key takeaways

This study evaluates a new combination of two existing CML drugs: Scemblix and Iclusig.
It's for people with chronic myeloid leukemia (CML) whose current treatments aren't effective enough.
The main goals are to check if the combination is safe and if it helps reduce CML cells.
Participants will take the combined medication and have regular check-ups, blood tests, and bone marrow tests.
The study aims to offer a better treatment option for CML patients who need alternative therapies.

Who may be eligible?

This study is designed for adults aged 18 years and older. Both men and women can participate. Participants must have chronic myeloid leukemia (CML) that has stopped responding well to one or both of the medicines being studied, Scemblix and Iclusig.

To be eligible, you would likely need to have specific test results showing that your CML is resistant to your current treatment. The study team will review your medical history and test results very carefully to ensure you meet all the necessary requirements.

There will be other detailed medical criteria that the study doctors will check to make sure the study is a safe and appropriate option for you. This might include certain blood test results, heart health checks, and other conditions that could affect your participation.

Could this study suit you?

Answer these quick questions to see if you may be eligible. This is a guide only — the research team makes the final call.

Are you 18 years old or older?
Do you have chronic myeloid leukemia (CML)?
Has your CML not responded well to treatments like Scemblix or Iclusig alone?
Are you prepared to attend regular clinic visits for tests and check-ups?

Answer every question to see your result.

What does participation involve?

If you decide to take part in this study, you would be taking a combination of Scemblix and Iclusig tablets. These would be taken as prescribed by the study doctors. You would have regular visits to the clinic for various check-ups. These visits will involve blood tests to monitor how the treatment is working and to keep an eye on your general health and any potential side effects.

You would also undergo bone marrow tests at specific times to see how well the treatment is reducing your leukemia cells. Doctors will ask you about any side effects you experience so they can be managed. The total duration of your participation in the study is not specified, but it will involve ongoing follow-up to track your health and treatment response over time.

Potential risks and benefits

Potential benefits of joining this study include the possibility of receiving a new combination treatment that might be more effective for your chronic myeloid leukemia if existing treatments aren't working well. This could lead to a better response to treatment and improved health outcomes. However, like all medications, the study drugs carry potential risks, including side effects that can range from mild to severe, and may require changes to your dosage or even stopping the treatment. There is also no guarantee that the treatment will be effective for you. You are free to withdraw from the study at any time and for any reason without it affecting your usual medical care.

Locations (1)

Some site locations are approximate. We're improving this — please verify with the trial team before travelling.

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Unverified
Spain

Common questions

What is chronic myeloid leukemia (CML)?

CML is a type of cancer that begins in the blood-forming cells of the bone marrow. It causes too many white blood cells to be made.

What are Scemblix and Iclusig?

These are both medicines already approved for treating CML. This study is looking at using them together.

Why is this study being done?

This study aims to find a new and more effective treatment option for CML patients whose current medications are no longer working as well as they should be.

What does 'MR2' mean?

MR2 is a way for doctors to measure how well treatments are working. It means that the number of leukemia cells has been reduced to a very low level in the body.

What will happen if I join the study?

You'll take the study medicines and have regular visits for blood tests, check-ups, and possibly bone marrow tests to see how you're responding and to monitor for any side effects.