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Study on Stopping Nilotinib for Chronic Myeloid Leukemia Patients After Previous Unsuccessful Attempts to Stop Tyrosine Kinase Inhibitors

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What is this trial about?

A plain-language summary of the goals, design and what participants do

This clinical trial focuses on patients with Chronic Myeloid Leukemia (CML), a type of cancer that affects the blood and bone marrow. The study is examining the effectiveness of a medication called nilotinib, which is taken in the form of hard capsules known as Tasigna. Nilotinib is a type of drug called a tyrosine kinase inhibitor (TKI), which works by blocking certain proteins that promote the growth of cancer cells.

The purpose of the study is to evaluate how well nilotinib can help maintain a state of remission, where signs of the disease are reduced or not detectable, after patients have previously tried and stopped other TKI treatments without success. Participants in the study will have been treated with TKIs for at least three years, including at least two years with nilotinib, and will have shown stable remission for a specified period before stopping the medication again.

During the study, participants will stop taking nilotinib to see if they can remain in remission without the medication. The study will monitor how long patients can stay in remission after stopping the treatment for the second or third time. The trial will also look at overall survival and the chances of the disease not getting worse over time. The study is expected to continue until 2028, with regular check-ups to assess the participants' health and remission status.

The research process

The trial runs in 5 steps – from screening to follow-up. Each step says what happens and what the team monitors.

Step 1
Joining the trial
Upon joining the trial, ensure that all eligibility criteria are met. This includes being at least 18 years old and having a specific type of chronic myeloid leukemia (CML) with certain genetic markers.
Provide written informed consent to participate in the study.
Step 2
Treatment phase
During the treatment phase, take Tasigna 150 mg hard capsules orally as prescribed. The medication contains the active substance nilotinib.
Continue this treatment for at least two years, ensuring stable molecular remission levels are maintained for the required duration before considering stopping the medication.
Step 3
Stopping medication
After meeting the criteria for stable remission, stop taking the medication as directed by the study protocol.
This phase involves monitoring the body's response to stopping the medication, focusing on maintaining remission without the drug.
Step 4
Monitoring phase
Regular check-ups will be scheduled to monitor molecular remission levels. This includes assessments at 12 months and 36 months after stopping the medication.
The primary goal is to observe molecular relapse-free survival, ensuring that the disease does not return during this period.
Step 5
Follow-up assessments
Additional assessments will be conducted at 12, 18, 24, and 36 months to evaluate overall survival and progression-free survival probabilities.
These assessments help determine the long-term outcomes of stopping the medication and the potential for regaining remission if needed.

Who can join the trial?

5 criteria

Must be at least 18 years old.
Must have a specific type of leukemia called Chronic Myeloid Leukemia (CML) with a positive test for the Ph chromosome and/or the BCR-ABL fusion gene. These are specific genetic markers associated with CML.
Must have tried to stop treatment with a medication called imatinib or other similar medications known as TKIs (Tyrosine Kinase Inhibitors) before, but it was not successful.
Must have been treated with any TKI for at least one year after the first or second attempt to stop the medication.
Must provide written informed consent, which means agreeing to participate in the study after being fully informed about it.

Who cannot join the trial?

6 criteria

Patients who have not been treated with a TKI (Tyrosine Kinase Inhibitor) for at least one year after their first attempt to stop treatment.
Patients who have not maintained a stable MR4 (Molecular Response 4) for at least one year before stopping treatment.
Patients who have not maintained a stable MR4.5 (Molecular Response 4.5) for at least six months before stopping treatment.
Patients who have not been treated with nilotinib for at least two years.
Patients who have not had at least three years of prior TKI treatment.
Patients who did not fail a first or second stop attempt according to the EURO-SKI criteria.

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Verified sites

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Justus-Liebig-Universitaet Giessen
Giessen, Germany
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Klinikum Bayreuth GmbH
Bayreuth, Germany
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Martin-Luther-Universitaet Halle-Wittenberg
Halle (Saale), Germany

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Investigated drugs

Nilotinib is a medication used in this clinical trial. It is designed to help patients with chronic myeloid leukemia (CML) maintain a state of remission, which means that the signs and symptoms of the cancer are reduced or disappear. In this trial, patients have already been treated with nilotinib for at least two years and have achieved a stable, deep remission. The goal is to see if stopping the medication for a second or third time can still keep the cancer under control. Nilotinib works by targeting specific proteins in cancer cells, which helps to stop their growth and spread.

Nilotinib

What is already known about the treatment

Nilotinib – Nilotinib is a medication taken orally, usually in the form of capsules, and is used to treat chronic myeloid leukemia (CML) in patients who have not successfully stopped previous treatments with other similar drugs. It is currently recognized in medical literature as a treatment option for CML, particularly for patients who have tried and failed to discontinue therapy with other tyrosine kinase inhibitors (TKIs). The main therapeutic use of nilotinib is to help maintain remission in CML patients who have previously stopped TKI therapy but need additional support to keep the disease under control. At the molecular level, nilotinib works by blocking specific proteins that promote the growth of cancer cells, thereby slowing down or stopping the progression of the disease. It is classified pharmacologically as a tyrosine kinase inhibitor, which is a type of targeted cancer therapy.

Investigated diseases

Chronic Myeloid Leukemia – Chronic Myeloid Leukemia (CML) is a type of cancer that affects the blood and bone marrow. It is characterized by the overproduction of immature white blood cells, known as myeloid cells. The disease progresses slowly and is divided into three phases: chronic, accelerated, and blast crisis. In the chronic phase, patients may experience mild symptoms or none at all, while the accelerated phase involves more severe symptoms and a higher number of abnormal cells. The blast crisis phase is marked by a rapid increase in immature white blood cells, leading to more severe symptoms. CML is often associated with a genetic abnormality known as the Philadelphia chromosome.