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Study of dose reduction strategy for tyrosine kinase inhibitors (imatinib, ponatinib, bosutinib, nilotinib, dasatinib) in patients with chronic myeloid leukemia

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 Chronic Myeloid Leukemia, a type of blood cancer that affects white blood cells. The research examines several medications known as tyrosine kinase inhibitors, which include imatinib, ponatinib, bosutinib, nilotinib, and dasatinib. These medications work by blocking specific proteins that contribute to cancer cell growth.

The purpose of this research is to evaluate how patients respond when their medication dose is reduced. The study will monitor patients who have shown a good response to their current treatment and investigate if maintaining disease control is possible with lower doses of these medications.

During the study, participants will continue taking their prescribed medication but at reduced doses. The treatment period will last for 12 months, during which doctors will regularly monitor the patient's response to the adjusted medication doses. All medications will be taken by mouth. The maximum daily doses vary depending on the specific medication: imatinib (800 mg), ponatinib (45 mg), bosutinib (500 mg), nilotinib (400 mg), or dasatinib (140 mg).

The research process

The trial runs in 4 steps – from screening to follow-up. Each step says what happens and what the team monitors.

  1. Step 1

    Initial assessment

    You have been diagnosed with chronic myeloid leukemia (CML) and are currently taking one of these medications: imatinib, ponatinib, bosutinib, nilotinib, or dasatinib

    Your doctor has confirmed that you have maintained a major molecular response (MMR) for at least 6 months, which means your disease is well-controlled

  2. Step 2

    Treatment phase begins

    Your current medication (known as a tyrosine kinase inhibitor or TKI) will be gradually reduced in dosage

    The medication continues to be taken orally as prescribed

    Your current dose may already be lower than the standard dose - this is acceptable for the study

  3. Step 3

    Monitoring period

    Your response to the reduced medication dose will be monitored for 12 months

    Regular tests will check if your major molecular response (MMR) remains stable

    If needed, your original dose may be restored during this period

  4. Step 4

    Study completion

    The study will evaluate if the reduced dose was successful in maintaining disease control

    The total study duration extends until August 2025

    Your participation will help determine if lower doses of these medications can effectively control CML

Who can join the trial?

13 criteria

  • Must be 18 years or older
  • Diagnosed with chronic phase CML (chronic myeloid leukemia in its early, more manageable stage)
  • Currently receiving treatment with TKI medications (targeted therapy drugs) such as:
    • Imatinib
    • Bosutinib
    • Dasatinib
    • Nilotinib
    • Ponatinib
    • Must have achieved and maintained a major molecular response (MMR) (a significant reduction in cancer cells) for at least 6 continuous months when joining the study
    • Must be physically and mentally capable of participating in the study
    • Must provide written informed consent (formal agreement to participate)
    • Can be either male or female
    • Can be taking a lower than standard dose of TKI medication
    • Can have previously switched between different TKI medications due to side effects

Who cannot join the trial?

12 criteria

  • Age below 18 years or above 65 years
  • Not having chronic myeloid leukemia (a type of blood cancer)
  • Not achieving MMR (Major Molecular Response - a measure of treatment success in leukemia)
  • Pregnancy or breastfeeding
  • History of poor compliance with medical treatments
  • Participation in other clinical trials within the last 30 days
  • Presence of significant heart, liver, or kidney disease
  • Active or uncontrolled infections
  • Mental conditions that could interfere with understanding study requirements
  • Known allergies to study medications
  • Recent major surgery (within last 4 weeks)
  • Any condition that, in the investigator's opinion, makes the patient unsuitable for the study
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Investigated drugs

Tyrosine kinase inhibitors (TKIs) are medications used to treat chronic myeloid leukemia. These drugs work by blocking specific proteins (tyrosine kinases) that are responsible for the growth of cancer cells. TKIs help control the disease by preventing the abnormal white blood cells from multiplying. This study looks at how these medications can be reduced in dosage while maintaining their effectiveness in treating leukemia. Note: Since the source data doesn't specify which particular TKIs are being used in this trial, I can only provide a general description of this class of medications. Common TKIs used in chronic myeloid leukemia treatment include imatinib, nilotinib, and dasatinib, but the specific ones used in this trial are not mentioned in the provided data.

What is already known about the treatment

Tyrosine Kinase Inhibitors (TKIs) - A class of oral medications used in the treatment of chronic myeloid leukemia (CML) that work by blocking specific proteins responsible for cancer cell growth. These medications are taken as tablets once or twice daily and have revolutionized the treatment of CML, turning it from a fatal disease into a manageable chronic condition. TKIs function by specifically targeting and inhibiting the BCR-ABL protein, which is the main driver of leukemia cell proliferation in CML, effectively stopping cancer cells from multiplying while allowing normal cells to function. The most common TKIs used in CML treatment include imatinib, nilotinib, and dasatinib, which are all well-documented in medical literature and approved by major drug regulatory agencies worldwide.

Investigated diseases

Chronic Myeloid Leukemia - A blood and bone marrow cancer that develops when the bone marrow makes too many white blood cells. The condition begins in a blood-forming cell of the bone marrow that produces too many abnormal white blood cells called granulocytes. These abnormal cells grow slowly but eventually crowd out healthy blood cells in the bone marrow. The disease typically progresses through three phases: chronic phase, accelerated phase, and blast phase. During the chronic phase, which can last several years, patients may have few or no symptoms as the disease develops gradually. The condition is characterized by the presence of an abnormal chromosome called the Philadelphia chromosome.
Trial detailsLast updated 7 Oct 2026
Age18+ yearsPhasePhase ITrial ID2024-516511-24-00Estimated enrolment136 patientsSponsorStichting Radboud universitair medisch centrum

sourced from the EU Clinical Trials Register and site verification

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