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 study about?

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.

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 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 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 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 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 Study?

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 Study?

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.

Where you can join this trial?

Verified and Recommended Sites

No sites found in this category

Verified Sites

Site Name	City	Country
Oncopole Claudius Regaud	Toulouse	France
Centre Hospitalier Universitaire De Lille	Lille	France
Centre Hospitalier Regional Et Universitaire De Brest	Brest	France

Other Sites

Site Name	City	Country
Centre Hospitalier De Versailles	Le Chesnay-Rocquencourt	France
Centre Hospitalier Universitaire De Poitiers	Poitiers	France
Centre Hospitalier Groupe Hospitalier De La Rochelle Re Aunis	La Rochelle	France
Centre Hospitalier De La Cote Basque	Bayonne	France
Centre Hospitalier Metropole Savoie	Chambery	France
Centre Hospitalier Universitaire De Nantes	Nantes	France
Centre Hospitalier De Perigueux	Perigueux	France
Hopital Beaujon	Clichy	France
L’Hopital Prive Du Confluent	Nantes	France
Centre Hospitalier Intercommunal De Mont De Marsan Et Du Pays Des Sources	Mont-de-Marsan	France
Cainjd Ludo Bgfupo	Lyon	France
Cuqxwg Hjnacdnuvbc Ds Bqsgq	Brive La Gaillarde	France
Cue dhcsyyqlohysqc	Epagny Metz Tessy	France
Cjbgrk Hcsrugyvvdy Es Ukctxqenikrlp Db Lrbzboc	Limoges	France
Cbguly Hssbgmoifue Rbqskeao Ubzlsshwgmhhw Du Txyem	Tours	France
Cyim Dm Njkry	Vandoeuvre Les Nancy	France
Cddife Hvkcxdnibsp Rdrquhkl Djabfotgxncjom	Angers	France

Trial status

Country	Status	Recruitment Start
France	Not recruiting	01.12.2023

Trial locations

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.

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 ID:

2024-515479-36-00

Protocol code:

AITIK

NCT ID:

NCT05753384

Trial Phase:

Therapeutic confirmatory (Phase III)

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

What is this study about?

Who Can Join the Study?

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