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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 study about?

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.

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.

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.

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.

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.

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 Study?

  • 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 Study?

  • 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.

Where you can join this trial?

Verified and Recommended Sites

No sites found in this category

Verified Sites

Site Name City Country Status
Universitaetsklinikum Heidelberg AöR Heidelberg Germany

Other Sites

Site Name City Country Status
Kliniken Ostalb gemeinnuetzige kommunale Anstalt des oeffentlichen Rechts Mutlangen Germany
Justus-Liebig-Universitaet Giessen Giessen Germany
MVZ Onkologische Schwerpunktpraxis Esslingen Esslingen Am Neckar Germany
Kdmvycbe Bwrdeecg Gcft Bayreuth Germany
Mmhyrgugellnryvhzqroekaecb Hecmmdnuzycukjya Halle (Saale) Germany

Want to learn more about this study or check if you can participate? Contact us.

Trial status

Country Status Recruitment Start
Germany Germany
Not yet recruiting
20.09.2016

Trial locations

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.

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.

Trial ID:
2024-519472-69-00
Protocol code:
CAMN107ADE22T
NCT ID:
NCT02917720
Trial Phase:
Therapeutic exploratory (Phase II)

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