HOVON 141 CLL: A prospective, multicenter, phase-II trial of ibrutinib plus venetoclax in patients with creatinine clearance ≥ 30 ml/min who have relapsed or refractory chronic lymphocytic leukemia (RR-CLL) with or without TP53 aberrations.
This research study, called HOVON 141 CLL, is investigating a new way to treat chronic lymphocytic leukemia (CLL) in people whose cancer has returned after initial treatment or has not responded to previous treatments. It combines two existing medications, ibrutinib (IMBRUVICA) and venetoclax (Venclyxto), which are given as tablets or capsules. The main goal is to find out how many patients remain free from their cancer getting worse 12 months after they stop taking the treatment. Researchers will also look at whether the cancer cells are still present in very small numbers, how long people live, and what side effects might occur. This is a Phase II study, meaning it's exploring how well this new combination works.
At a glance
What is this study about?
This study, called HOVON 141 CLL, is for people who have chronic lymphocytic leukemia (CLL). This is a type of cancer that affects white blood cells. The study is specifically for patients whose CLL has either come back after they've had other treatments, or if their previous treatments haven't worked well enough.
The main aim of this study is to see how effective a combination of two medicines, ibrutinib (known as IMBRUVICA) and venetoclax (known as Venclyxto), is at treating CLL. Both medicines are taken as tablets or capsules. Researchers want to know how many patients remain well without their cancer getting worse 12 months after they finish the treatment. They are also looking closely at whether tiny amounts of cancer cells (called 'minimal residual disease' or MRD) are still present, how long people live, and any side effects that might happen.
This is a 'Phase II' study, which means it's one of the earlier steps in testing new treatments. It's designed to gather more information about how well this combination works and to check its safety, rather than comparing it directly to standard treatments. The insights gained from this study will help doctors understand if this combination could be a good future treatment option for CLL.
Key takeaways
- This study is for adults with chronic lymphocytic leukemia (CLL) that has returned or not responded to past treatments.
- It tests a combination of two existing drugs: IMBRUVICA (ibrutinib) and Venclyxto (venetoclax).
- The main goal is to see how many patients stay free of cancer progression 12 months after stopping treatment.
- Participation involves taking daily medication and regular clinic visits for monitoring.
- You can stop participating at any time without affecting your future medical care.
Who may be eligible?
To join this study, participants need to be adults, aged 18 years or older, with a diagnosis of chronic lymphocytic leukemia (CLL).
Your CLL must have either returned after you've had previous treatments, or it must not have responded well to those treatments. Doctors will also check your kidney function to make sure it meets specific levels to ensure the treatments are suitable for you.
Both men and women can take part in this study. The medical team will review your health information to confirm if you meet all the necessary requirements to ensure your safety and the accuracy of the study results.
- Are you 18 years old or older?
- Do you have chronic lymphocytic leukemia (CLL)?
- Has your CLL come back or not responded well to previous treatments?
- Has your doctor confirmed your kidney function is suitable for the study medications?
This is a guide only — the research team will confirm whether you can take part.
What does participation involve?
If you decide to take part in this study, you will be taking two different medications, ibrutinib (IMBRUVICA) and venetoclax (Venclyxto), which come as tablets or capsules. The study involves regular visits to the clinic for check-ups, blood tests, and other assessments. These visits will help the doctors monitor your health, how you are responding to the treatment, and any side effects you might experience.
After a period of treatment, some patients may be able to stop taking the medications. However, you will still have follow-up appointments and tests for an extended period, potentially for several years, to see how long the treatment effect lasts and to monitor your long-term health. The total duration of your involvement could be several years, including the active treatment phase and the follow-up period.
Potential risks and benefits
Locations (6)
- —Sweden
- —Netherlands
- —Belgium
- —Norway
- —Finland
- —Denmark
Common questions
What type of cancer is this study for?
This study is for chronic lymphocytic leukemia (CLL), a type of cancer affecting white blood cells.
What medicines are being tested?
The study is testing a combination of two medicines: ibrutinib (known as IMBRUVICA) and venetoclax (known as Venclyxto).
Why is this study being done?
This study aims to find out how well this new combination treatment works for CLL that has come back or not responded to previous treatments, and to check its safety.
Are these new medicines?
No, these are existing medicines that are being tested together as a new combination therapy for CLL.
What is a 'Phase II' study?
A Phase II study is an early stage of research to see if a new treatment or combination of treatments is effective and safe before comparing it to standard treatments in larger studies.
How to find out more
Always speak to your GP or specialist before deciding to take part in a study.
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