AuthorisedTherapeutic exploratory (Phase II)Interventional

Multicenter prospective trial after first or second unsuccessful treatment discontinuation in chronic myeloid leukemia estimating the efficacy of nilotinib in inducing the persistence of molecular remission after stopping TKI 2nd or 3rd time

This study is for adults with Chronic Myeloid Leukaemia (CML) who have already tried to stop their CML medication (called TKIs) once or twice without success. It's looking at a specific medication, nilotinib (also known as Tasigna), to see if it can help patients stay in remission — meaning the CML is not detectable — after they try to stop their main CML treatment again. This is a Phase II study, which means it builds on earlier research and aims to see how well nilotinib works and if it's safe. Researchers will be checking if patients remain free of CML for 12 and 36 months after trying to stop their treatment. They will also be looking at overall health, how many patients can achieve a very low level of disease, and how quickly CML becomes undetectable again if it does reappear.

At a glance

Status

Authorised

Phase

Therapeutic exploratory (Phase II)

Sponsor

Heidelberg University

Enrolment target

Start

27 Nov 2024

CML-Patients in chronic phase having failed a prior attempt to stop imatinib or other TKIs therapy either within EURO-SKI or not and are pretreated at least one year with any TKI after 1st stop

What is this study about?

This study is for people who have Chronic Myeloid Leukaemia (CML), a type of cancer that starts in the bone marrow. The main treatment for CML is with medicines called tyrosine kinase inhibitors, or TKIs. Sometimes, people with CML can try to stop taking their TKI medication if their disease has been very well controlled for a long time. This is often called a 'treatment-free remission' attempt.

However, for some people, the CML can start to become detectable again after they stop their TKI. When this happens, they usually go back on their TKI medication. This study is specifically designed for people who have already tried to stop their TKI treatment once or twice before, but it didn't work out as hoped.

The main goal of this study is to see if a different medicine called nilotinib (brand name Tasigna) can help these patients. Researchers want to find out if taking nilotinib can help people stay in remission – meaning their CML remains undetectable – after they attempt to stop their main TKI treatment for a second or third time. The study will carefully follow participants to see how many stay free of detectable CML at 12 months and 36 months after trying to stop their treatment.

Key takeaways

This study is for adults with Chronic Myeloid Leukaemia (CML).
It's for patients who have tried to stop their CML medication (TKIs) before, but it didn't work.
The study looks at nilotinib (Tasigna) to help maintain remission after another attempt to stop TKIs.
Researchers will track if patients stay free of detectable CML for up to 3 years.
Participation involves taking nilotinib and having regular health check-ups.
You can stop participating at any time.

Who may be eligible?

To be eligible for this study, you need to be an adult, 18 years old or older, and your gender doesn't matter.

You should have Chronic Myeloid Leukaemia (CML) that has been successfully treated in the past. Importantly, you must have already tried to stop your CML medication (which are called TKIs, like imatinib) at least once, or even twice, and it didn't work as planned. This means your CML became detectable again after you stopped.

Also, after your first attempt to stop treatment, you must have been taking a TKI medication again for at least a year. If you fit these descriptions, you might be able to take part in this study.

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 Leukaemia (CML)?
Have you tried to stop your regular TKI medication for CML at least once before, but your CML became detectable again?
After your first attempt to stop, have you been back on a TKI medication for at least one year?
Are you willing to take the study medication (nilotinib) and attend regular appointments?

Answer every question to see your result.

What does participation involve?

If you join this study, you would begin taking the study medication, Tasigna (nilotinib) 150 mg capsules. The exact schedule of your medication and any doctor's visits would be explained in detail by the study team. You would have regular check-ups and tests, such as blood tests, to monitor your CML and your general health, and to see how well the treatment is working. The main focus is to track whether your CML stays undetectable (molecular remission) at 12 months and 36 months after you try to stop your regular TKI medication for the second or third time. The total duration of your participation would involve the period you take nilotinib and then the follow-up period to check on your CML status over 36 months.

Potential risks and benefits

Taking part in this study could potentially offer a new approach if you have had trouble stopping your CML treatment in the past. You would be closely monitored by a medical team. As with any medication, there can be side effects from taking Tasigna (nilotinib), which the study team would explain in full detail. There's also no guarantee that the treatment will work for you. You are free to withdraw from the study at any time and for any reason, without it affecting your 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
Germany

Common questions

What is CML?

CML stands for Chronic Myeloid Leukaemia, a type of blood cancer that affects the bone marrow, where blood cells are made.

What does 'stopping TKI' mean?

It means attempting to stop taking your main CML medication (a Tyrosine Kinase Inhibitor, or TKI) if your CML has been very well controlled for a long time.

Why is this study important for people who have already tried to stop TKI?

This study is for people whose CML became detectable again after a previous attempt to stop treatment. It aims to find a way to help them successfully stay off their medication after trying again.

What is nilotinib (Tasigna)?

Nilotinib is a medication used to treat CML. In this study, it's being explored to help maintain remission after trying to stop other TKIs.

Will I have to have many extra appointments if I join?

Yes, you would have regular appointments and tests to check your health and CML status. The study team will explain the full schedule.