Ongoing, recruitingTherapeutic exploratory (Phase II)Interventional

Venetoclax after TKI to target persisting stem cells in CML

This study is for people who have Chronic Myeloid Leukaemia (CML) that is currently well managed by usual treatments. Even when CML seems to be under control, a small number of leukaemia cells can sometimes remain, hidden in the bone marrow. These are called 'stem cells' and they can potentially cause the CML to come back later. This trial is investigating whether adding a new medication called Venetoclax to their current treatment can specifically target and reduce these hidden leukaemia stem cells. The main goal is to measure if Venetoclax can lower the number of these specific cells in the bone marrow. This is a Phase II study, meaning it's exploring if this new approach works and is safe in a group of people. It’s for adults aged 18 and over, both men and women.

At a glance

Status

Ongoing, recruiting

Phase

Therapeutic exploratory (Phase II)

Sponsor

Friedrich-Schiller-Universitaet Jena

Enrolment target

Start

15 Oct 2024

Chronic Myeloid Leukemia

What is this study about?

Imagine your body has tiny factories producing blood cells. In Chronic Myeloid Leukaemia (CML), some of these factories start making faulty cells, but medicines have become very good at controlling this.

Even when the regular medicines work really well and your CML seems almost gone, a very small number of problem cells, often called 'stem cells,' can sometimes still be hiding. These stubborn cells are like tiny seeds that could potentially regrow the leukaemia later on. Doctors are keen to find ways to get rid of these remaining cells.

This study is testing a new medication called Venetoclax. It's already used for other types of blood cancers, but this trial is looking at whether it can help tackle those hidden CML stem cells. The main aim is to see if adding Venetoclax can reduce the number of these specific leukaemia cells in your bone marrow, which will be measured carefully. This research helps us understand if this new treatment approach could eventually lead to even better outcomes for people with CML.

Key takeaways

This study explores a new drug (Venetoclax) for CML.
It aims to target hidden 'stem cells' that might remain after standard treatment.
Participation involves adding Venetoclax to your current CML medication.
The main goal is to see if Venetoclax can reduce these specific leukaemia cells in your bone marrow.
It's for adults aged 18 and over whose CML is well controlled.
You'll be closely monitored throughout the study.

Who may be eligible?

To join this study, you need to be an adult, aged 18 or older. Both men and women are welcome to take part.

Crucially, you must have been diagnosed with Chronic Myeloid Leukaemia (CML). Your CML should already be responding well to your current standard treatment. This means your leukaemia counts are low and stable, because the study is specifically looking at those 'hidden' cells that remain even when treatment is successful.

There will be other detailed medical checks to make sure the study is safe and suitable for you. These will likely include reviewing your overall health, other medications you take, and certain blood test results. Your doctor will discuss all these specifics with you.

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?
Have you been diagnosed with Chronic Myeloid Leukaemia (CML)?
Is your CML currently well-controlled with your usual medication?
Are you willing to potentially take a new medication (Venetoclax) in addition to your current one?
Are you able to attend regular hospital appointments and have routine tests, including bone marrow sampling?

Answer every question to see your result.

What does participation involve?

If you decide to take part, you would receive the study drug, Venetoclax. This would be in addition to your current medication for CML. You would have regular appointments at the hospital for blood tests, physical examinations, and to discuss how you are feeling. The most important test for this study is a bone marrow sample, which will be taken to measure the remaining leukaemia cells. This helps the researchers understand if the new drug is working as intended.

The research team will tell you exactly how often these visits and tests will be, typically spread out over a period of time. You will be closely monitored throughout the study. The total duration of your participation in the study, including follow-up appointments, will be clearly explained to you by the study team.

Potential risks and benefits

Participating in this study might offer you a potential benefit by targeting those lingering leukaemia cells that your current treatment may not fully address. This could potentially lead to a deeper and longer-lasting control of your CML, though this is not guaranteed as it is still being investigated. However, like all medications, Venetoclax can have side effects, which the study team will discuss in detail with you. There are also potential risks associated with the tests, such as bone marrow sampling. You will receive very careful monitoring by the study team. Remember, joining is always your choice, and you have the right to withdraw from the study at any time without it affecting your usual 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
Germany

Common questions

What is CML?

CML stands for Chronic Myeloid Leukaemia, which is a type of cancer that affects the blood and bone marrow. It usually progresses slowly at first.

What does 'persisting stem cells' mean?

Even when CML is well-controlled, a tiny number of 'seed' leukaemia cells can remain hidden. These are called persisting stem cells, and they might cause the CML to return later.

What is Venetoclax?

Venetoclax is a medication that works by targeting specific proteins in cancer cells, causing them to die. It's already used for some other blood cancers.

Will I have to stop my current CML medicine?

No, this study involves adding Venetoclax to your current CML medicine, not replacing it. You will continue your usual treatment.

What is a 'Phase II' study?

A Phase II study is a stage of research where doctors are trying to find out if a new treatment works, if it's safe, and what the best dose might be, usually in a smaller group of people.