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Study on Stopping Dasatinib in Patients with Chronic Myeloid Leukemia After a Previous Attempt to Stop Treatment

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 clinical trial is focused on studying a condition known as Chronic Myeloid Leukemia (CML). The trial involves patients who have previously attempted to stop their medication but needed to restart it. The medication being studied is called dasatinib, which is available in the form of film-coated tablets under the brand name SPRYCEL. The purpose of the study is to assess whether patients can maintain a state called major molecular remission, which means the disease is under control at a molecular level, after stopping the medication for a second time.

Participants in this study will have been treated with dasatinib for at least two years and must have shown a significant reduction in disease markers for at least one year. The study will observe patients over a period to see if they can maintain remission without the medication. The trial will also look at various factors that might influence the success of stopping the medication, such as biological markers and previous treatment history.

The study will monitor the proportion of patients who maintain remission at six and twelve months after stopping the medication again. It will also track any side effects that occur when the medication is stopped and any factors that might predict the success of stopping the medication. The trial aims to provide insights into the possibility of living without continuous medication for those with Chronic Myeloid Leukemia.

The research process

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

Step 1
Initial assessment
The trial begins with an initial assessment to confirm eligibility. This includes verifying a diagnosis of chronic myeloid leukemia (CML) and ensuring previous treatment with tyrosine kinase inhibitors (TKI) for at least three years, with the last two years using dasatinib.
Eligibility also requires that the patient has been in a state called MR4, which means a very low level of leukemia cells, for at least one year.
Step 2
Medication discontinuation
Patients who meet the criteria will stop taking their TKI medication, specifically SPRYCEL (dasatinib), which is available in 20 mg and 50 mg film-coated tablets.
The goal is to observe if the patient can maintain a major molecular remission (MMR), which means keeping leukemia cells at a low level, without the medication.
Step 3
Monitoring phase
During the monitoring phase, the patient's health and leukemia cell levels are regularly checked. This phase lasts for 12 months.
The primary focus is to see if the patient maintains MMR at 6 and 12 months after stopping the medication.
Step 4
Evaluation of outcomes
The trial evaluates the proportion of patients who maintain MMR without medication.
Secondary outcomes include the number of patients who regain stable MR4, overall survival, and any adverse events related to stopping the medication.
Step 5
Conclusion of trial
The trial is expected to conclude by December 31, 2026.
Final results will include data on the persistence of MMR and any factors that may influence the success of stopping TKI treatment.

Who can join the trial?

9 criteria

You must have **chronic myeloid leukemia (CML)**, which is a type of blood cancer.
You should be in the **chronic phase (CP)** of CML, which means the disease is in its early stage.
You must have been treated with **TKI (tyrosine kinase inhibitors)**, which are medications used to treat CML, for at least three years.
You should have tried to stop TKI treatment before, either in a specific study called **EURO-SKI** or in a similar way, but the attempt was not successful.
You need to have been in a state called **MR4** for at least one year before stopping TKI. MR4 means a very low level of cancer cells in your blood.
You must have been treated with TKI for at least one more year after the first attempt to stop TKI treatment failed.
Your CML must have a specific type of genetic marker called **BCR/ABL1 transcript** (b3a2 and/or b2a2), which should have been confirmed when you were diagnosed or later.
You must be **18 years or older**.
Both **men and women** can participate in the study.

Who cannot join the trial?

4 criteria

Patients who have not been treated for at least three years with a specific type of medication called TKI (Tyrosine Kinase Inhibitor).
Patients who have not used a medication called dasatinib for the last two years of their treatment.
Patients who have not achieved a state called MR4 (a very low level of disease) for at least one year.
Patients who are part of a vulnerable population, which means they might need special protection or care.

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Verified sites

All sites with verified contact details – recruitment status may not be available; ask directly

Amsterdam UMC
Responsive
Amsterdam, The Netherlands
Centre Hospitalier Universitaire De Lille
Verified
Lille, France
Region Midtjylland
Responsive
Aarhus, Denmark

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Investigated drugs

Dasatinib is a medication used in the treatment of chronic myeloid leukemia (CML). In this clinical trial, patients who have previously attempted to stop treatment with tyrosine kinase inhibitors (TKIs) and experienced a relapse are given dasatinib for at least two years. The goal is to achieve and maintain a major molecular remission, which means the disease is under control at a molecular level, allowing patients to potentially stop treatment again.

Dasatinib

What is already known about the treatment

Dasatinib – Dasatinib is administered orally in tablet form. It is currently used in the treatment of chronic myeloid leukemia (CML) and is well-documented in medical literature as a second-generation tyrosine kinase inhibitor (TKI). The main therapeutic indication for dasatinib is to treat patients with CML, particularly those who have not responded to other treatments. At the molecular level, dasatinib works by inhibiting the BCR-ABL protein, which is responsible for the uncontrolled growth of cancer cells in CML. It belongs to the pharmacological class of tyrosine kinase inhibitors, which block specific enzymes involved in the growth of cancer cells.

Investigated diseases

Chronic Myeloid Leukemia – This is a type of cancer that affects the blood and bone marrow. It is characterized by the overproduction of immature white blood cells. The disease progresses slowly and may not show symptoms initially. Over time, it can lead to fatigue, weight loss, and an enlarged spleen. The condition is associated with a genetic change known as the Philadelphia chromosome. As the disease advances, it can transform into a more aggressive form of leukemia.