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

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What is this study about?

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.

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

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

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

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

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 Study?

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 Study?

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

Where you can join this trial?

Verified and Recommended Sites

No sites found in this category

Verified Sites

Site Name	City	Country	Status
Azienda Ospedaliero Universitaria Careggi	Florence	Italy

Other Sites

Site Name	City	Country
Azienda Sanitaria Locale Roma 2	Rome	Italy
Hospital Santa Maria Della Misericordia	Perugia	Italy
Azienda Ospedaliera Ordine Mauriziano Di Torino	Turin	Italy
Fondazione IRCCS Ca Granda Ospedale Maggiore Policlinico	Milan	Italy
IRCCS Ospedale Policlinico San Martino	Genoa	Italy
Universita’ Di Pisa	Pisa	Italy
Azienda Ospedaliero-Universitaria Maggiore Della Carita	Novara	Italy
Acospyg Ovtodqmugio Unilkaisxjgcf Slsmau	Siena	Italy
Auqbwak Omerrwqtxnb Upxsvdfdogogi Ctpgcbnijgxo Dolso Scamuq E Ddrar Szcgnyf Dk Tfxdla	Turin	Italy
Afeuvhz Ukdby Sgvjqueye Lseoop Dy Bqlvqsd	Bologna	Italy
Upgmwgfihh Dnxvi Skvog Dz Rwax Lc Slqujsdz	Rome	Italy

Trial status

Country	Status	Recruitment Start
Italy	Not recruiting	18.02.2019

Trial locations

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.

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.

Trial ID:

2024-516122-66-00

Protocol code:

CAMN107AIT15

Trial Phase:

Therapeutic exploratory (Phase II)

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

What is this study about?

Who Can Join the Study?

Who Cannot Join the Study?