Active not recruitingPHASE2INTERVENTIONAL

2nd or 3rd TKI-stop After 2 Years Nilotinib Pre-treatment in CML-patients

This research is for people with a type of blood cancer called Chronic Myeloid Leukemia (CML) who have been treated with nilotinib and had their cancer well under control for a long time. The study wants to see if they can safely stop their nilotinib medication a second or third time. This is especially for patients who tried to stop their medication before, but their cancer levels started to rise again, meaning they had to restart treatment. The study involves taking nilotinib again for a period, then stopping it under close monitoring to see how long the cancer stays under control without medication. The aim is to understand if this 'treatment-free remission' can be achieved again for these patients.

At a glance

Status

Active not recruiting

Phase

PHASE2

Sponsor

European LeukemiaNet

Enrolment target

Start

01 Sep 2016

Estimated completion

01 Sep 2027

Chronic Myeloid Leukemia

What is this study about?

Imagine you have a long-term blood cancer called Chronic Myeloid Leukemia (CML). Treatments called TKIs, like nilotinib, are very good at controlling it, often for many years. Sometimes, if the cancer has been very quiet and undetectable for a long time, doctors might consider carefully stopping the TKI medication. This is called 'treatment-free remission' and it means you wouldn't need to take daily medication anymore, which can improve your quality of life.

However, for some people, when they stop their medication, the cancer activity starts to show signs of coming back. If this happens, they usually need to start taking their TKI again. This study is specifically designed for those individuals who had to restart their medication after an earlier attempt to stop.

The main idea is to see if, after taking nilotinib again for a period and getting the cancer back under very good control, these patients can successfully stop the medication for a second or third time. The researchers will closely watch the cancer levels to understand how long it stays under control without treatment, and hopefully, more people can achieve a lasting break from their medicine.

Key takeaways

This study explores stopping CML medication (nilotinib) a second or third time.
It's for CML patients who previously tried to stop but had to restart treatment.
You would take nilotinib again for at least two years to get CML well-controlled.
Your CML levels will be very closely monitored, especially after stopping the drug.
The goal is to achieve lasting 'treatment-free remission', improving quality of life.

Who may be eligible?

To be considered for this study, you must be at least 18 years old and have Chronic Myeloid Leukemia (CML) that has been checked and confirmed in your blood tests. A key requirement is that you must have tried to stop your TKI medication (like nilotinib) before, but then had to restart it because your CML levels increased. You would also need to have been on some form of TKI treatment for at least one year since that previous attempt to stop.

There are also some reasons why you might not be able to join. For example, if your CML got significantly worse and led to a 'hematological relapse' after your previous attempt to stop treatment, you wouldn't be eligible. Also, if you've had certain other serious medical conditions, such as severe heart problems, uncontrolled diabetes, or certain liver/kidney diseases, or if you've had a stem cell transplant, you wouldn't be able to take part. Women who are pregnant or breastfeeding, or who are not willing to use effective contraception, also cannot join 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 or older?
Do you have CML that has been stable for a long time?
Have you tried to stop your CML medication (TKI) before but had to restart it?
Have you been on TKI treatment for at least one year since your last attempt to stop?
Do you have any significant heart problems or other serious medical conditions?
Are you pregnant, breastfeeding, or willing to use effective contraception?

Answer every question to see your result.

What does participation involve?

If you join this study, you will first need to take nilotinib (usually 300 mg twice a day) for at least two years. During this time, your CML levels will be checked every three months with blood tests to ensure your cancer remains very well-controlled. Once your CML levels have been consistently very low for a specific period (at least one year at a 'major molecular response' and at least six months at an even deeper 'MR4.5' level), you will enter the screening phase.

After doctors confirm your CML is still at a very low level, you will then stop taking nilotinib. Your CML levels will be monitored very closely: monthly for the first six months, then every six weeks for the next six months, and finally every three months after that. If your CML levels start to rise above a certain point, you will be advised to restart nilotinib. The total duration of your involvement could be several years, depending on how long you take nilotinib before stopping and how long you remain in remission afterwards.

Potential risks and benefits

A potential benefit of joining this study is the chance to achieve 'treatment-free remission' – meaning you could live without taking daily medication for your CML, which can improve your daily life. However, there's always a risk that your CML levels might rise again after stopping nilotinib, meaning you would need to restart treatment. Nilotinib itself can also have side effects, and some health conditions would prevent you from taking part because of these potential risks. You would be closely monitored throughout the study, especially after stopping medication. Remember, you have the right to withdraw from the study at any time, for any reason, without it affecting your usual medical care.

Locations (15)

Universitätsklinikum Freiburg
Verified postcode
Freiburg im Breisgau, Germany
Universitätsmedizin Mannheim
Verified postcode
Mannheim, Germany
Klinikum rechts der Isar
Verified postcode
München, Germany
Medizinische Hochschule Hannover
Approximate
Hannover, Germany
Universitätsklinikum der RWTH
Verified postcode
Aachen, Germany
Klinikum Bayreuth
Verified postcode
Bayreuth, Germany
Klinikum Chemnitz
Verified postcode
Chemnitz, Germany
Onkologische Schwerpunktpraxis
Verified postcode
Esslingen am Neckar, Germany
Universitätsklinikum Halle (Saale)
Verified postcode
Halle, Germany
Schwerpunktpraxis Onkologie
Verified postcode
Heilbronn, Germany
Klinikum der Philipps-Universität
Verified postcode
Marburg, Germany
Kliniken Ostalb, Stauferklinikum Schwäbisch Gmünd
Verified postcode
Mutlangen, Germany

Common questions

What is CML?

CML stands for Chronic Myeloid Leukemia, a type of blood cancer where too many white blood cells are made in the bone marrow.

What is nilotinib?

Nilotinib is a medicine used to treat CML. It's a type of drug called a Tyrosine Kinase Inhibitor (TKI), which helps control the cancer cells.

What does 'stopping TKI' mean?

It means carefully stopping your CML medication, often after a long period of good cancer control, to see if your body can keep the cancer under control without daily pills.

What if my CML comes back after I stop the medicine?

If your CML levels start to rise, you would typically restart your nilotinib treatment to get the cancer back under control. This study involves close monitoring for this reason.

Why is this study important?

It aims to help more people with CML live without daily medication, especially those who previously tried but couldn't stay off their treatment, improving their quality of life.