AuthorisedTherapeutic exploratory (Phase II)Interventional

Efficacy of asciminib in chronic phase CML patients with T315l mutations

Chronic myeloid leukaemia (CML) is a type of blood cancer that causes the body to produce too many white blood cells. Many people manage CML well with daily medicines. However, leukaemia cells can sometimes develop changes, such as the T315I mutation, which make standard treatments stop working. This Phase II study is testing a newer targeted tablet called asciminib (brand name Scemblix). Asciminib attacks leukaemia cells in a different way, which may overcome this treatment resistance. The study aims to find out how well asciminib lowers the amount of leukaemia in the body after 12 months of treatment. Researchers will also monitor participants for up to two years to see how long the treatment keeps the leukaemia under control, track any side effects, and check how the treatment affects everyday quality of life.

At a glance

Status

Authorised

Phase

Therapeutic exploratory (Phase II)

Sponsor

Friedrich-Schiller-Universitaet Jena

Enrolment target

Start

23 Jun 2026

Chronic Myeloid Leukemia

What is this study about?

Chronic myeloid leukaemia (CML) is a slow-growing cancer of the bone marrow and blood. Over the last two decades, targeted therapies have transformed CML into a manageable condition for most people. Even so, leukaemia cells can change over time. One particular genetic change, known as the T315I mutation, prevents several standard medicines from locking onto cancer cells, leaving patients with limited treatment choices.

This study looks at a targeted drug called asciminib (also known as Scemblix). Unlike older therapies that attach to leukaemia cells at one specific site, asciminib works by binding to a different part of the cancer protein to shut it down. Scientists hope this unique approach will bypass the roadblock caused by the T315I mutation and get the leukaemia back under control.

During the trial, doctors will carry out highly sensitive blood tests to measure the exact amount of leukaemia remaining in the blood. The main goal is to see how many patients reach a safe, very low level of leukaemia cells after one year. The research team will also follow patients over two years to measure overall survival, monitor symptoms, and assess day-to-day well-being.

Key takeaways

Tests asciminib (Scemblix) tablets for adults with chronic phase CML.
Specifically focuses on leukaemia carrying the T315I mutation.
Aims to reduce leukaemia cells in the blood to very low levels over 12 to 24 months.
Involves regular hospital check-ups, blood tests, and quality-of-life surveys.
Participation is entirely voluntary and does not impact your right to standard NHS care.

Who may be eligible?

This trial is designed for adults aged 18 and over who have been diagnosed with chronic myeloid leukaemia in its chronic (stable) phase.

To be considered, your leukaemia cells must have the T315I mutation. Your hospital doctor will usually check for this mutation using specialised blood tests if your previous treatments have stopped working well.

Because patient safety is essential, the study team will also review your overall health, other medical conditions, and test results to confirm that taking asciminib is safe and appropriate for you.

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.

I am aged 18 or older.
I have been diagnosed with chronic phase chronic myeloid leukaemia (CML).
Genetic testing has shown my leukaemia has the T315I mutation.
I am able to take daily tablets by mouth.
I am willing and able to attend hospital visits and blood tests for up to two years.

Answer every question to see your result.

What does participation involve?

If you take part, you will be prescribed asciminib (Scemblix) as 40 mg film-coated tablets to take by mouth every day at home. You will attend regular hospital appointments for check-ups and safety checks over a period of two years. During these visits, doctors will take blood samples at set times (such as months 3, 6, 9, 12, 18, and 24) to track leukaemia levels using sensitive tests. You will also be asked to complete short questionnaires about your symptoms, daily activities, and general quality of life.

Potential risks and benefits

Taking part may help lower your leukaemia levels and keep your condition stable when other medicines have stopped working, though individual results cannot be guaranteed. The information gathered may also help doctors improve care for other patients in the future. As with any drug, asciminib can cause side effects, which your clinical team will explain and monitor closely. Joining this study is completely voluntary; you can choose to leave at any point, and your standard NHS medical care will not be affected.

Locations (1)

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

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Unverified
Germany

Common questions

What is the T315I mutation?

It is a specific change in the leukaemia cells that acts like a altered lock, preventing many standard CML medicines from working effectively.

How do I take asciminib?

Asciminib is taken as a tablet by mouth once or twice daily, following the instructions given by your trial doctor.

Will I be given a dummy pill (placebo)?

No. In this study, all eligible participants receive the active trial medicine, asciminib.

How will doctors know if the medicine is working?

You will have regular blood tests that look closely at your genetic markers to count how many leukaemia cells remain in your body.

Can I leave the study if I change my mind?

Yes. You are free to stop taking part at any time without giving a reason, and your medical team will help you choose another treatment.