Ongoing, recruitingTherapeutic exploratory (Phase II)Interventional

A phase II, single-arm study of de-escalation and treatment-free remission in patients with chronic myeloid leukemia treated with nilotinib in first-line therapy followed by a second attempt after nilotinib and asciminib combination: DANTE study

This study, called DANTE, is for people with a type of blood cancer called chronic myeloid leukaemia (CML). It’s investigating a new way to manage CML where patients might be able to stop their medication (either Tasigna or Scemblix) after successful initial treatment. The study has two main stages where participants will try to enter a 'treatment-free remission', meaning they are well without needing daily drugs. If the cancer starts to become detectable again, they may go back onto treatment or switch to a combination of medications. The goal is to see how many people can successfully stop treatment and remain healthy, and what happens if they need to restart or change their medicine.

At a glance

Status

Ongoing, recruiting

Phase

Therapeutic exploratory (Phase II)

Sponsor

Novartis Farma S.p.A.

Enrolment target

170

Start

09 Sep 2024

Chronic myeloid leukemia

What is this study about?

This clinical trial, called DANTE, is for individuals living with Chronic Myeloid Leukaemia (CML). CML is a type of cancer that affects the blood and bone marrow. While there are effective medications for CML, many people wonder if they can eventually stop taking these drugs and still remain healthy. This study is designed to explore just that.

The DANTE study is investigating a strategy where patients who have been stable on their initial CML medication (Tasigna) might be able to gradually reduce or even stop their treatment. This is done in two stages, where doctors carefully monitor blood tests to see if the leukaemia remains controlled without daily medication. The aim is to achieve what's called a 'treatment-free remission' – essentially, being well without needing to take regular anti-cancer drugs.

If the leukaemia cells start to become detectable again during this treatment-free period, participants would go back on their medication or potentially switch to a combination of Tasigna and Scemblix. The study will carefully track how many people successfully stay in remission without treatment, how long this lasts, and what happens to those who need to restart or change their medication. This research is important because it could help understand if patients can safely achieve a better quality of life without continuous drug therapy, while still keeping their CML under control.

Key takeaways

The DANTE study explores if CML patients can stop medication.
It aims for a 'treatment-free remission' in two stages.
Participants take Tasigna and may later take Scemblix if needed.
Regular blood tests are crucial to monitor leukaemia levels.
The study could lead to new ways of managing CML without lifelong drugs.
You can always choose to leave the study.

Who may be eligible?

To be considered for this study, you must be an adult aged 18 or older. Both men and women are welcome to participate. The study is specifically for people who have chronic myeloid leukaemia (CML).

There are also specific medical requirements related to your CML and how you've been treated so far. For example, your leukaemia needs to have responded well to your current medication (nilotinib, also known as Tasigna) for a certain period, and your blood test results for the leukaemia cells (called BCR-ABL levels) need to be very low and stable.

Your study doctor will discuss all the detailed criteria with you to make sure this trial is the right fit. They will check your medical history, current health, and past CML treatments to see if you meet all the necessary requirements.

Could this study suit you?

Answer these quick questions to see if you may be eligible. This is a guide only — the research team makes the final call.

Are you 18 years old or older?
Do you have Chronic Myeloid Leukaemia (CML)?
Have you been taking Tasigna (nilotinib) as your first treatment?
Have your CML blood test results (BCR-ABL levels) been very low and stable for a while?
Are you willing to attend regular clinic appointments for blood tests and check-ups?

Answer every question to see your result.

What does participation involve?

If you join the DANTE study, you will initially be taking a medication called Tasigna (nilotinib). The study involves a careful process of potentially reducing and then stopping this medication in two stages, aiming for a 'treatment-free' period. Throughout these stages, you'll have regular blood tests to monitor your leukaemia cells (BCR-ABL levels).

If your leukaemia cells become detectable again during a treatment-free stage, you would restart Tasigna or potentially switch to a combination of Tasigna and Scemblix. The study will involve frequent visits to the clinic for these blood tests and to check on your overall health. The total duration of your participation will depend on how you respond to the treatment de-escalation and remission stages, but it will involve several years of follow-up.

Potential risks and benefits

Participating in this study might offer the benefit of potentially stopping your daily CML medication, which could improve your quality of life by reducing side effects and the burden of continuous treatment. However, there's a risk that your leukaemia might become detectable again if you stop treatment, meaning you would need to restart medication, possibly at a higher dose or with a different combination. There could also be side effects from the medications used. You have the full right to withdraw from the study at any time, for any reason, without affecting your standard medical care.

Locations (1)

Some site locations are approximate. We're improving this — please verify with the trial team before travelling.

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Unverified
Italy

Common questions

What is CML?

CML stands for Chronic Myeloid Leukaemia. It's a type of cancer that affects the blood and bone marrow, where a specific genetic change leads to the production of too many white blood cells.

What does 'treatment-free remission' mean?

It means your leukaemia is controlled and undetectable even though you are not taking regular medication. The goal is to see if you can remain healthy without daily drugs.

What medications are involved?

The main medications involved are Tasigna (nilotinib) and Scemblix (asciminib). These are taken as tablets or capsules.

What happens if my leukaemia comes back?

If your leukaemia cells become detectable during a treatment-free period, you would restart your medication, potentially with a switch or a combination of Tasigna and Scemblix.

How long will the study last?

The study involves several years of monitoring, including different stages of treatment reduction and follow-up, depending on your individual response.