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Study on Stopping Tyrosine Kinase Inhibitors in Chronic Myeloid Leukemia Patients: Comparing Dasatinib, Imatinib, Nilotinib, and Bosutinib Strategies

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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 the treatment of Chronic Myeloid Leukemia (CML), a type of cancer that affects the blood and bone marrow. The study involves the use of medications known as Tyrosine Kinase Inhibitors (TKIs), which are designed to block the action of enzymes that promote the growth of cancer cells. The medications being studied include Sprycel (dasatinib), Glivec (imatinib), Tasigna (nilotinib), and Bosulif (bosutinib). These medications are taken orally in the form of tablets or capsules.

The purpose of the study is to compare two different strategies for stopping the use of TKIs in patients with CML. The study will explore how these strategies affect the likelihood of successfully discontinuing the medication while monitoring the impact on the immune system. Participants will be randomly assigned to one of the two strategies and will be followed for a period of time to observe the outcomes. Some participants may receive a placebo as part of the study.

Throughout the study, participants will be monitored for any changes in their condition and any side effects they may experience. The study aims to gather information on the proportion of patients who can maintain treatment-free remission, which means staying in remission without the need for ongoing medication. The study will also collect data on the quality of life and any adverse events that occur. The estimated end date for the study is June 2029.

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

    Joining the study

    Upon joining the study, the patient must meet specific criteria, including being at least 18 years old and having a diagnosis of chronic myeloid leukemia (CML) in the chronic phase.

    The patient must have been treated with tyrosine kinase inhibitors (TKIs) for a specified duration and must not have had a dose reduction in the last six months.

  2. Step 2

    Treatment phase

    During the treatment phase, the patient continues taking their prescribed TKI medication. The options include Sprycel (dasatinib), Glivec (imatinib), Tasigna (nilotinib), and Bosulif (bosutinib).

    The dosage must meet the minimum requirements: dasatinib at least 50 mg per day, imatinib at least 300 mg per day, nilotinib at least 300 mg per day, and bosutinib at least 200 mg per day.

  3. Step 3

    Monitoring and evaluation

    The patient's response to the treatment is monitored, focusing on maintaining a deep molecular response (DMR) and major molecular response (MMR).

    Regular assessments are conducted to record any adverse events and evaluate the patient's health status using specific health questionnaires.

  4. Step 4

    Discontinuation phase

    The study involves two strategies for discontinuing TKI treatment: dose maintenance followed by discontinuation, and dose de-escalation followed by discontinuation.

    The primary goal is to assess the proportion of patients who remain in treatment-free remission (TFR) 24 months after discontinuation.

  5. Step 5

    Follow-up

    After discontinuation, the patient is closely monitored for any loss of molecular response. If a loss occurs, the time to regain the response is recorded.

    The study aims to evaluate the impact of TKI discontinuation on the immune system, specifically analyzing certain immune cells.

Who can join the trial?

9 criteria

  • Patient must be **18 years or older**.
  • Must have been diagnosed with **Chronic Myeloid Leukemia (CML)** in the chronic phase, according to specific medical criteria, with a typical genetic change called **BCR::ABL1 rearrangement**.
  • Must have been treated with **Imatinib** for at least 4 years, or a second-generation TKI (TKI2G) for at least 3 years, or a combination of Imatinib and TKI2G for at least 4 years, without reducing the dose in the last 6 months. **TKI** stands for Tyrosine Kinase Inhibitor, a type of medication used to treat CML.
  • Must have had a **deep molecular response (DMR)** for at least 1 year. This means a significant reduction in the level of a specific genetic marker in the blood.
  • No medical reasons should prevent the continuation of the same TKI medication for 12 months at the same dosage, as recommended internationally. This includes specific medications like **Glivec® (Imatinib)**, **Sprycel® (Dasatinib)**, **Tasigna® (Nilotinib)**, and **Bosulif® (Bosutinib)**.
  • Sexually active men should use **contraception** while taking Dasatinib to prevent pregnancy.
  • Must be affiliated with the **social security system** or have someone who is.
  • Patient should not be participating in another **interventional study** during the study period.
  • Must have **signed the consent form** after reading the information provided about the study.

Who cannot join the trial?

4 criteria

  • Patients who have not been diagnosed with Chronic Myeloid Leukemia (CML) cannot participate. CML is a type of cancer that affects the blood and bone marrow.
  • Patients who are not within the specified age range cannot participate. The age range is typically defined by the study.
  • Patients who are not treated with TKIs cannot participate. TKIs, or Tyrosine Kinase Inhibitors, are a type of medication used to treat CML.
  • Patients who are part of a vulnerable population cannot participate. Vulnerable populations may include groups like children, pregnant women, or those unable to give consent.
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Investigated drugs

Tyrosine Kinase Inhibitors (TKIs) are a type of medication used to treat chronic myeloid leukemia (CML). They work by blocking certain proteins called tyrosine kinases, which are involved in the growth and spread of cancer cells. In this clinical trial, the focus is on stopping the use of TKIs to see how it affects the patients and their immune systems. The study aims to compare two different strategies for discontinuing these medications to determine which method is more successful in maintaining remission in patients with CML.

What is already known about the treatment

Tyrosine Kinase Inhibitors (TKIs) – These medications are typically administered orally in the form of tablets. They are well-established in medical practice and literature, particularly for the treatment of Chronic Myeloid Leukemia (CML). TKIs work by blocking the action of specific enzymes called tyrosine kinases, which are involved in the signaling pathways that promote cancer cell growth. By inhibiting these enzymes, TKIs help to prevent the proliferation of cancer cells. They are classified as targeted cancer therapies due to their specific action on cancer cell mechanisms.

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. These cells gradually accumulate in the blood and bone marrow, interfering with the production of normal blood cells. CML typically progresses through three phases: chronic, accelerated, and blast crisis, with each phase showing an increase in the number of immature cells. In the chronic phase, symptoms may be mild or absent, but as the disease progresses, symptoms such as fatigue, weight loss, and an enlarged spleen may occur. The disease is often associated with a specific genetic abnormality known as the Philadelphia chromosome.
Trial detailsLast updated 2 Oct 2026
Age18+ yearsPhasePhase IIITrial ID2024-515479-36-00Protocol codeAITIKEstimated enrolment170 patientsSponsorCentre Hospitalier Universitaire De Poitiers

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On this site, “treatment” means an investigational medicine being studied in a clinical trial. Its safety and efficacy for the use being studied have not yet been confirmed, some participants may receive a placebo or a comparator medicine, and taking part does not guarantee any health benefit. The decision to take part is made by the doctor at the research site. This site is for information only and does not replace medical advice.

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