Ongoing, recruitingTherapeutic exploratory (Phase II)Interventional

A phase II trial of belimumab in combination with rituximab/venetoclax in patients with refractory or relapsed chronic lymphocytic leukemia

This research study is for people with chronic lymphocytic leukaemia (CLL) that has either returned after previous treatment or has been hard to treat successfully. The main aim is to test a new combination of treatments: a drug called belimumab along with rituximab and venetoclax. Doctors want to find out how well this new combination can clear up all signs of the leukaemia in the blood. They will also be closely monitoring for any side effects and looking at how patients feel overall. This type of study, called a Phase II trial, helps us understand if new treatments are promising and safe enough to be studied in more detail in the future.

At a glance

Status

Ongoing, recruiting

Phase

Therapeutic exploratory (Phase II)

Sponsor

Universitaetsklinikum Tuebingen AöR

Enrolment target

120

Start

19 Jul 2024

refractory or relapsed chronic lymphocytic leukemia

What is this study about?

This study is looking into a new way to treat a type of blood cancer called chronic lymphocytic leukaemia, or CLL. This particular study is for people whose CLL has either come back after they've had treatment before, or if their CLL hasn't responded well to previous treatments. It can be a very worrying time, and doctors are always looking for better and kinder ways to help.

The main idea behind this study is to combine a new drug called belimumab with two medicines already used for CLL, named rituximab and venetoclax. Researchers want to see if this new combination works really well to get rid of even tiny traces of the cancer cells in the blood. This is often called 'minimal residual disease negativity', which simply means no cancer cells can be found using very sensitive tests.

By taking part, you would be helping doctors learn more about this potential new treatment. They will closely watch how the treatment affects your CLL, how you feel, and if there are any side effects. All this information helps advance our understanding of CLL and discover new treatment options for patients in the future.

Key takeaways

This study evaluates a new combination treatment for CLL that has returned or is hard to treat.
It combines belimumab with existing drugs, rituximab and venetoclax.
The main goal is to see if the treatment can eliminate all signs of leukaemia from the blood.
Researchers will closely monitor for effectiveness, side effects, and overall well-being.
Participation involves regular hospital visits for treatment, tests, and follow-up.
You can withdraw from the study at any time without affecting your future medical care.

Who may be eligible?

This study is open to both men and women who are 18 years old or older. You would be considered if you have chronic lymphocytic leukaemia (CLL) that has either returned after you've had treatment for it before, or if your CLL has been difficult to treat successfully with previous medications.

There will be other medical checks and tests to make sure that the treatment is suitable for you and that you meet all the safety requirements for the study. These checks are important to ensure your well-being throughout the trial.

Each patient's situation is unique, so the study doctors will go through all the detailed criteria with you to see if you are a good fit for this particular study. It's always best to discuss this with your own doctor.

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 lymphocytic leukaemia (CLL)?
Has your CLL either come back after past treatment or been difficult to treat?
Are you able to attend regular hospital appointments for treatment and tests?

Answer every question to see your result.

What does participation involve?

If you decide to join this study, you would first go through some health checks to make sure it's right for you. The treatment would involve receiving the study medicines in cycles. You would have regular appointments at the hospital for blood tests, check-ups, and to receive your medication. Doctors would keep a close eye on any side effects you might experience and how your body is responding to the treatment.

Throughout the study, you'd have specialised blood tests to look for any remaining cancer cells. You would also have regular assessments of your overall health and quality of life. The study involves a treatment period, followed by a time where you'll still be monitored regularly. The total duration of your involvement could be several months or even longer, with follow-up checks continuing for some time after the main treatment phase ends.

Potential risks and benefits

Taking part in any medical study has both potential benefits and risks. A potential benefit of this study is that the new combination treatment might be more effective in controlling your CLL than standard treatments, especially if your leukaemia has been hard to treat. However, there's no guarantee it will work for everyone. As with all medications, there's a chance you might experience side effects, some of which could be serious. The study team will explain all known side effects and monitor you closely. You are free to withdraw from the study at any time, for any reason, without it affecting your future 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 chronic lymphocytic leukaemia (CLL)?

CLL is a type of cancer that affects white blood cells called lymphocytes and usually progresses slowly. It's often found in the blood and bone marrow.

What does 'refractory or relapsed' mean?

It means your CLL has either come back after treatment (relapsed) or it hasn't responded to previous treatments (refractory).

What is a Phase II trial?

A Phase II trial is a type of study that checks if a new treatment is safe and effective enough to be tested in a larger group of people. It looks at how well the treatment works and any side effects.

What is 'minimal residual disease (MRD)'?

MRD refers to tiny numbers of cancer cells that can be left in the body after treatment. Even if they're very few, they can sometimes lead to the cancer returning.

Will I get belimumab, rituximab, and venetoclax?

Yes, if you meet the study criteria and join, you would receive belimumab in combination with rituximab and venetoclax as part of the study treatment plan.