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Comparison of Nilotinib versus Imatinib treatment in newly diagnosed chronic myeloid leukemia patients to achieve treatment-free remission

Verified siteRegistered drugNo placebo
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What is this trial about?

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

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.

The research process

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

  1. Step 1

    Initial 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

  2. Step 2

    Treatment 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

  3. Step 3

    24-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

  4. Step 4

    Treatment-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

  5. Step 5

    Long-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 trial?

13 criteria

  • 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 trial?

15 criteria

  • 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
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Investigated 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.

What is already known about the treatment

  • Nilotinib

    An oral targeted therapy medication used in the treatment of Chronic Myeloid Leukemia (CML) in chronic phase, administered as capsules. This drug belongs to the class of tyrosine kinase inhibitors and works by blocking specific proteins (BCR-ABL) that cause the growth of cancer cells. Nilotinib is often used as a first-line treatment or when other treatments like Imatinib are not providing optimal response, showing improved efficacy in achieving treatment-free remission in clinical studies.

  • Imatinib

    An oral chemotherapy medication taken in tablet form, primarily used as a first-line treatment for Chronic Myeloid Leukemia (CML) in chronic phase. As a tyrosine kinase inhibitor, it specifically targets and blocks the BCR-ABL protein responsible for abnormal cell growth in CML. Imatinib was one of the first targeted therapies developed for CML and has revolutionized the treatment of this disease, though some patients may need to switch to alternative treatments like Nilotinib if optimal response is not achieved.

Investigated diseases

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.
Trial detailsLast updated 7 Oct 2026
Age18+ yearsPhasePhase IIITrial ID2023-510434-83-00Protocol codeCML1415 - SustrenimEstimated enrolment450 patientsSponsorFondazione Gimema Franco Mandelli Onlus

sourced from the EU Clinical Trials Register and site verification

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