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Study of treatment discontinuation with nilotinib and asciminib in adults with chronic myeloid leukemia to achieve treatment-free remission

Fast replyRegistered 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 patients with Chronic Myeloid Leukemia, a type of blood cancer affecting white blood cells. The research evaluates the possibility of stopping or reducing treatment while maintaining disease control. The study uses two medications: nilotinib (Tasigna) and asciminib (Scemblix), which are taken as oral tablets or capsules to treat the disease.

The main purpose is to determine if patients can safely stop their treatment and remain in remission (when the disease is under control). The study involves two attempts at treatment-free periods. In the first attempt, patients who have been taking nilotinib will try stopping their medication. If this is not successful, patients will receive a combination of nilotinib and asciminib before attempting a second treatment-free period.

Throughout the study, patients will be closely monitored through regular blood tests to measure the levels of disease markers. The total duration of the study is approximately 144 weeks, during which patients will receive different combinations of medications or attempt periods without treatment, depending on how their disease responds.

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 treatment phase
You will receive nilotinib (Tasigna) at a daily dose of 300 mg twice a day
This phase lasts for at least 3 calendar years
Regular blood tests will monitor your response to treatment
Step 2
Consolidation phase
Your treatment continues with nilotinib for 48 weeks
Blood tests will be performed to measure BCR-ABL levels (a marker that shows how well the treatment is working)
To proceed to the next phase, you need to maintain specific response levels in your blood tests
Step 3
First treatment-free phase (TFR1)
If your blood test results meet the required criteria, you will stop taking nilotinib
Regular monitoring will continue through blood tests for 96 weeks
Your doctor will check if you maintain good response without medication
Step 4
Reinduction phase
If the treatment-free phase is not successful, you will restart nilotinib treatment
You will receive a combination of nilotinib and asciminib (Scemblix)
This phase lasts for at least 1 year
Regular blood tests will continue to monitor your response
Step 5
Second treatment-free phase (TFR2)
If your blood tests show good response, you may attempt a second treatment-free period
This phase will be monitored for 48 weeks
Regular blood tests will continue to check your response

Who can join the trial?

9 criteria

Age 18 years or older
Diagnosed with Chronic Phase CML (a type of blood cancer) according to World Health Organization criteria, with no history of disease progression to advanced phases
Must have been treated with nilotinib (a cancer medication) as first treatment for at least 3 years
Must have achieved and maintained a deep molecular response (MR4 or better, meaning very low levels of cancer cells in blood) for at least 4 consecutive tests over 3-6 months
Must have adequate blood test results including: - Sufficient white blood cells (neutrophils) - Sufficient platelets - Adequate hemoglobin levels - Normal kidney function - Normal liver function - Normal pancreatic enzyme levels - Normal levels of potassium, magnesium, and calcium
Must have good physical functioning ability (ECOG performance status of 0-2, meaning able to care for self and be up and about more than 50% of waking hours)
Must be able to follow study procedures and attend follow-up appointments
Must provide signed informed consent to participate in the study
For those entering the second treatment-free phase (TFR2): Must have previously attempted stopping treatment, resumed treatment for at least 1 year, and signed additional consent

Who cannot join the trial?

15 criteria

Age below 18 years or above 65 years
Previous unsuccessful attempts at treatment-free remission (TFR)
Not achieving Major Molecular Response (MMR) - which means a significant reduction in cancer cells
Pregnancy or breastfeeding
Serious heart conditions
Active infections
Other types of cancer present
Severe kidney or liver problems
Mental conditions that could affect ability to follow study requirements
Use of medications that could interact with the study treatment
Participation in other clinical trials within the last 30 days
Known allergies to components of the study medication
Unstable medical conditions that could interfere with study participation
Unable to provide informed consent
History of poor compliance with medical treatments

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Verified sites

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Azienda Ospedaliera Ordine Mauriziano Di Torino
Responsive
Turin, Italy
Azienda Ospedaliera Universitaria Senese
Responsive
Siena, Italy
Azienda Ospedaliero Universitaria Careggi
Responsive
Florence, Italy

Trial locations

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Investigated drugs

Nilotinib
This medication is used as a first-line therapy for chronic myeloid leukemia. It belongs to a class of drugs called tyrosine kinase inhibitors, which work by blocking certain proteins that signal cancer cells to multiply. It helps control the growth of cancer cells in the blood and bone marrow.
Asciminib
This is a newer medication for chronic myeloid leukemia that works differently from traditional treatments. It specifically targets a protein called BCR-ABL1, which is responsible for the development of leukemia. It is used in combination with nilotinib in this study to potentially improve treatment outcomes and help patients achieve treatment-free remission.

What is already known about the treatment

Nilotinib
An oral targeted therapy medication used in the treatment of chronic myeloid leukemia (CML), belonging to the class of tyrosine kinase inhibitors. It works by blocking specific proteins (BCR-ABL tyrosine kinase) that are responsible for the growth of cancer cells, effectively controlling the progression of leukemia. The medication is typically administered in tablet form, with dosing determined by the patient's response and tolerance to treatment.
Asciminib
A newer generation targeted therapy medication for chronic myeloid leukemia, known as a specific BCR-ABL1 inhibitor, which works differently from traditional tyrosine kinase inhibitors. It is taken orally and specifically targets the ABL myristoyl pocket, providing an alternative mechanism of action for patients with CML. This medication represents an important treatment option, particularly for patients who may have developed resistance to other therapies.

Investigated diseases

Chronic Myeloid Leukemia - A type of blood cancer that begins in the bone marrow with abnormal growth of white blood cells. The condition develops when a genetic change occurs in the blood-forming cells, creating an abnormal gene called BCR-ABL. This causes the bone marrow to produce too many white blood cells that don't mature properly. The disease typically progresses slowly, developing in three phases: chronic phase, accelerated phase, and blast phase. In the early stages, many people may not experience any symptoms, or they may have mild symptoms like fatigue and weight loss.