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Study on Stopping Nilotinib, Imatinib, and Dasatinib in Patients with Chronic Myeloid Leukemia in Deep Remission

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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 type of blood cancer called chronic myeloid leukemia (CML). The study is examining the effects of stopping treatment with certain medications known as tyrosine kinase inhibitors (TKIs) after gradually reducing their doses. The medications involved in this study include Tasigna (nilotinib) in 150 mg and 200 mg hard capsules, Glivec (imatinib) in 100 mg hard capsules, and SPRYCEL (dasatinib) in 20 mg film-coated tablets. The purpose of the study is to evaluate the safety and effectiveness of discontinuing these medications in patients who have achieved a deep molecular remission, which means the cancer is under very good control at a molecular level.

Participants in the study will first undergo a two-step reduction in their TKI medication doses. After this reduction, the medications will be completely stopped. The study will monitor how well patients maintain their remission without the medication and how long they can stay in remission. The study will also observe any side effects that may occur when the medication is reduced or stopped. If the cancer shows signs of returning, the medication may be restarted to see if remission can be achieved again.

The study will last for several years, with regular check-ups to assess the patients' health and the status of their CML. The goal is to understand if patients can safely stop taking TKIs and still keep their cancer under control, which could improve their quality of life by reducing medication-related side effects. The study will also look at how stopping the medication affects other health factors, such as cholesterol levels and blood sugar. This research could provide valuable insights into managing CML more effectively in the future.

The research process

The trial runs in 6 steps – from screening to follow-up. Each step says what happens and what the team monitors.

Step 1
Initial dose reduction
The trial begins with a two-step reduction in the dose of tyrosine kinase inhibitors (TKIs). These medications include nilotinib, imatinib, and dasatinib, which are taken orally.
The specific dosage and frequency of administration will be adjusted according to the trial protocol, aiming to gradually reduce the medication dose while monitoring the patient's response.
Step 2
Monitoring phase
During the dose reduction phase, regular monitoring is conducted to assess the patient's response. This includes measuring the levels of the BCR-ABL1 gene fusion transcript, which is associated with chronic myeloid leukemia.
The goal is to maintain a major molecular response (MMR), which means keeping the BCR-ABL1 levels at or below 0.1%.
Step 3
Medication discontinuation
If the patient maintains a stable response during the dose reduction phase, the next step involves discontinuing the TKI medication.
The patient will continue to be monitored closely to ensure that the disease remains in remission without the need for medication.
Step 4
Follow-up assessments
Follow-up assessments are scheduled at 6, 12, 18, 24, and 36 months after the start of the trial to evaluate the patient's condition.
These assessments focus on maintaining the MMR and monitoring for any signs of molecular recurrence, which would indicate a need to restart TKI therapy.
Step 5
Response to recurrence
If a molecular recurrence is detected, the TKI medication may be reintroduced to regain control over the disease.
The time taken to re-establish MMR and deeper molecular responses will be evaluated to understand the effectiveness of reintroducing the medication.
Step 6
Evaluation of side effects
Throughout the trial, any side effects experienced during the dose reduction and discontinuation phases are assessed.
This includes monitoring for withdrawal symptoms and evaluating the correlation between previous side effects and potential withdrawal syndrome.

Who can join the trial?

9 criteria

Patients must have a confirmed diagnosis of **chronic myeloid leukemia (CML)** in the first chronic phase. This means having less than 15% of immature blood cells called blasts in the blood or bone marrow, less than 30% of blasts and promyelocytes combined, less than 20% of a type of white blood cell called basophils, at least 100 billion platelets per liter, and no disease outside the bone marrow except for possible liver or spleen enlargement.
Patients must be **18 years or older**.
Patients must have signed a form agreeing to participate in the study, known as **informed consent**.
Patients must have a specific type of genetic marker called **BCR-ABL1 transcript**, which can be typical or atypical, and it must be measurable on an international scale.
Patients must have been treated with a **tyrosine kinase inhibitor (TKI)**, which is a type of medication, either as their first treatment or as a second or later treatment if they couldn't tolerate the first one.
Patients must have been on **TKI treatment for more than 4 years**.
Patients who have previously been treated with **interferon-alpha** are allowed, regardless of how well it worked or if they couldn't tolerate it.
Patients must have a **deep molecular response**, which means a very low level of disease, for at least 2 years.
Patients who can have children must agree to use **reliable birth control methods** during the study and for one year after the last dose of the study medication. Women can use methods like hormonal contraceptives or non-hormonal devices, and men must use methods like condoms or practice abstinence.

Who cannot join the trial?

4 criteria

Patients who are not in a deep remission of their chronic myeloid leukemia. Deep remission means the disease is under very good control.
Patients who have not been taking a tyrosine kinase inhibitor for their condition. This is a type of medication used to treat certain cancers.
Patients who are younger than 18 years old or older than 65 years old.
Patients who are part of a vulnerable population, which means they might need special protection or care.

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Verified sites

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Verified
Fakultni Nemocnice Brno
Brno, Czechia
Verified
Fakultni Nemocnice Hradec Kralove
Novy Hradec Kralove, Czechia
Responsive
Fakultni Nemocnice Kralovske Vinohrady
Prague, Czechia

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Investigated drugs

Tyrosine Kinase Inhibitors are medications used to treat chronic myeloid leukemia by blocking specific proteins that promote the growth of cancer cells. In this trial, the focus is on evaluating the effects of stopping these medications after gradually reducing their dose in patients who have achieved a deep remission of their disease. The goal is to see if patients can maintain their remission without the need for continuous medication.

What is already known about the treatment

Tyrosine Kinase Inhibitors – These medications are typically administered orally in tablet form. They are currently being studied in clinical trials for their potential to be safely discontinued in patients with chronic myeloid leukemia who are in deep molecular remission. The main therapeutic indication for these inhibitors is chronic myeloid leukemia. At the molecular level, they work by blocking the activity of specific enzymes known as tyrosine kinases, which are involved in the signaling pathways that promote cancer cell growth. Tyrosine kinase inhibitors are classified as targeted cancer therapies.

Investigated diseases

Chronic Myeloid Leukemia – Chronic myeloid leukemia 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. This disease progresses slowly and may not show symptoms initially. Over time, it can lead to fatigue, weight loss, and an enlarged spleen. The disease is associated with a genetic change called the Philadelphia chromosome, which produces an abnormal protein that promotes cancer cell growth. As the disease advances, it can transform into a more aggressive form of leukemia.