This study focuses on patients with Chronic Myeloid Leukemia (CML) in its chronic phase, which is a type of blood cancer affecting white blood cells. The study compares two medications: Nilotinib (Tasigna) and Imatinib (Glivec), which are both taken as hard capsules by mouth. These medications work by targeting specific proteins that cause the abnormal growth of cancer cells.
The purpose of this research is to determine if starting treatment with Nilotinib is more effective than starting with Imatinib and then switching to Nilotinib if the initial response is not optimal. The study will examine how well these treatments work in helping patients achieve and maintain a treatment-free period where their disease remains under control without ongoing medication.
During the study, which lasts up to 48 months, patients will receive either Nilotinib (up to 600 mg daily) or Imatinib (up to 400 mg daily). Doctors will monitor the amount of cancer cells in the blood throughout the treatment period to determine how well the medications are working. The study will track how many patients can successfully stop treatment while maintaining control of their disease.
1Initial treatment phase
You will be assigned to receive either Nilotinib (Tasigna 150 mg capsules) or Imatinib (Glivec 100 mg capsules)
Both medications are taken by mouth as hard capsules
Your treatment will be monitored regularly to check how well it works
2Treatment adjustment
If you started with Imatinib and your response is not optimal, your treatment will be changed to Nilotinib
Regular blood tests will measure the levels of specific markers in your blood to determine how well the treatment is working
324-month evaluation
At 24 months, your doctor will check for a deep molecular response (a measure of how well the treatment is controlling the disease)
This evaluation helps determine the next steps in your treatment
4Treatment-free period
If your disease responds well to treatment, you may enter a period without medication
During this time, regular monitoring will continue to ensure the disease remains under control
This phase will be monitored for at least 12 months to check if the disease remains stable without treatment
5Long-term follow-up
Your health will be monitored for up to 60 months (5 years)
Regular check-ups will assess your overall health and how well the disease is controlled
Quality of life assessments will be conducted throughout the study period
Who Can Join the Study?
Must be at least 18 years old
Must have confirmed diagnosis of BCR/ABL+ Chronic Myeloid Leukemia in chronic phase with:
Less than 15% blasts in blood
Less than 30% blasts plus promyelocytes in blood
Less than 20% basophils in blood
Platelet count equal or greater than 100,000 per mm3
Must have ECOG performance status of 0-2 (ability to perform daily activities from fully active to being up more than 50% of waking hours)
Must have evidence of typical BCR-ABL transcripts that can be measured by standardized testing
Must have adequate organ function shown by:
Normal or slightly elevated bilirubin levels (liver function)
Liver enzymes (AST and ALT) no more than 3 times above normal
Pancreatic enzymes (amylase and lipase) no more than 2 times above normal
Alkaline phosphatase no more than 2.5 times above normal
Kidney function (creatinine) no more than 1.5 times above normal
Must provide written informed consent before any study procedures
Who Cannot Join the Study?
Age below 18 years or above 65 years
Previous treatment with any medication for Chronic Myeloid Leukemia (CML)
Pregnant or breastfeeding women
Active or uncontrolled infections
Significant heart problems, including:
Uncontrolled high blood pressure
Recent heart attack (within past 6 months)
Unstable heart rhythm disorders
Severe liver problems or abnormal liver function tests
Severe kidney problems or abnormal kidney function tests
Other types of cancer in the past 5 years
Mental conditions that could affect ability to follow study requirements
Participation in other clinical trials within past 30 days
Known allergies to study medications
Conditions that could interfere with oral medication absorption
Use of medications that could interact with study drugs
Nilotinib is a medication used to treat chronic myeloid leukemia (CML). It works by blocking certain proteins that cause cancer cells to grow and multiply. This medication helps control the disease and may lead to long-term remission in patients with CML.
Imatinib is also a medication used to treat chronic myeloid leukemia. It works by targeting specific proteins that are responsible for cancer cell growth. This was one of the first targeted therapies developed for CML and has been used successfully for many years to help patients manage their condition.
Both medications belong to a class of drugs called tyrosine kinase inhibitors, which work by blocking signals that cancer cells need to grow. The trial compares these treatments to find the most effective approach for achieving treatment-free remission in patients with chronic myeloid leukemia.
Chronic Myeloid Leukemia (CML) – A type of blood cancer that begins in the bone marrow, causing the body to produce too many white blood cells. The disease typically develops slowly during its chronic phase, which is characterized by an excessive production of mature and maturing granulocytes (a type of white blood cell). During the chronic phase, patients may experience mild symptoms such as fatigue, weight loss, night sweats, or an enlarged spleen. The condition is marked by the presence of a specific genetic change called the Philadelphia chromosome in the blood cells. CML in chronic phase is generally stable and develops more gradually compared to other forms of leukemia.
The website uses cookies to ensure the proper functioning of the site and to analyze internet traffic. Some cookies are essential for using the service and do not require consent. You can accept all cookies or use only the essential ones. Data is processed in accordance with our Privacy Policy. You have the right to withdraw your consent, access, rectify, delete, or limit the processing of your data at any time.
Italy 
The Netherlands 
