Belimumab in Patients with Chronic Lymphocytic Leukemia
This study is testing a new approach for people with chronic lymphocytic leukemia (CLL) where the cancer has returned or isn't responding well to previous treatments. It combines a drug called belimumab with the usual treatment of rituximab and venetoclax. The main goal is to see if adding belimumab can help clear more of the cancer cells earlier and more completely. This could potentially reduce how long people need to be on treatment, which might mean fewer side effects. We want to find out if this combination is safe and effective in improving results for patients. If successful, this could be a new way to help people with CLL achieve longer-lasting remissions.
At a glance
What is this study about?
Chronic lymphocytic leukemia (CLL) is a type of cancer that affects white blood cells. Over the past few years, new treatments have become available that have made a big difference for people with CLL. One common and effective treatment for CLL that has returned or isn't responding well is a combination of two drugs, rituximab and venetoclax. This treatment usually lasts for about two years and can work very well, getting rid of most of the cancer cells.
However, doctors are always looking for ways to make treatments even better. The main goals now are to get rid of *all* the cancer cells (known as achieving "minimal residual disease negativity") more often and to reach that point earlier in the treatment. If we can do this, it might mean people don't need to stay on treatment for as long, which could reduce side effects and the chance of the cancer becoming resistant to the drugs.
This study is looking at adding a third drug called belimumab to the standard rituximab/venetoclax treatment. Researchers believe that belimumab might help the other two drugs work more effectively by targeting a specific protein (called BAFF) that cancer cells sometimes produce to protect themselves. By removing BAFF, belimumab could make the cancer cells more vulnerable to rituximab and venetoclax. The study will assess if this combination is safe and if it helps more people achieve better and earlier clearance of their cancer cells.
Key takeaways
- This study evaluates adding belimumab to standard CLL treatment.
- It targets CLL that has returned or is resistant to previous treatments.
- The aim is to achieve better and faster cancer cell clearance.
- Potentially, treatment duration could be reduced over time.
- Participation involves weekly injections and standard drug therapy for up to two years.
- The study assesses safety and effectiveness of the new combination.
Who may be eligible?
This study is for adults, aged 18 or older, who have been diagnosed with chronic lymphocytic leukemia (CLL) and whose cancer has either returned after previous treatments or isn't responding. For example, your CLL might be causing significant symptoms like an enlarged spleen, swollen lymph nodes, unexplained weight loss, constant fevers, or severe tiredness.
You would need to have stopped any previous CLL treatments (like chemotherapy or other targeted drugs) at least two weeks before starting this study, unless you're on steroids for symptom control. Any side effects from your previous treatments should also have mostly cleared up. If you've had venetoclax before, you can only join this study if at least 18 months have passed since you stopped taking it and your CLL has returned.
Your general health also needs to be good enough to take part in the study. Your medical team will check all these criteria to make sure this study is right for 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?
- Do you have a diagnosis of CLL?
- Has your CLL come back or not responded well to previous treatments?
- Are you generally able to carry out your normal daily activities?
- Have you stopped any previous CLL treatments (except steroids) at least 2 weeks ago?
What does participation involve?
If you join this study, you will receive belimumab as a weekly injection under your skin, in addition to your standard rituximab and venetoclax treatment. The rituximab will be given as an infusion into a vein, and venetoclax is a tablet you take by mouth. This combination treatment will continue for up to 24 months.
You will have regular hospital visits for check-ups, blood tests, and to receive your rituximab infusions. Your doctors and nurses will monitor you closely to see how you are responding to the treatment and to check for any side effects. After the 24 months or if you stop treatment earlier, you will have follow-up visits to continue monitoring your health.
Potential risks and benefits
Locations (1)
- University Hospital Tuebingen, CCU Translational ImmunologyVerified postcodeTübingen, Germany
Common questions
What is CLL?
CLL stands for Chronic Lymphocytic Leukemia, a type of slow-growing cancer affecting certain white blood cells.
What does 'relapsed or refractory' mean?
It means your CLL has either come back after previously being treated, or it hasn't responded well to earlier treatments.
What are rituximab and venetoclax?
They are standard and effective medications currently used to treat CLL.
What is belimumab?
Belimumab is a drug being tested in this study to see if it can boost the effectiveness of rituximab and venetoclax for CLL.
How is belimumab given?
Belimumab is given as an injection under the skin, usually once a week.
How to find out more
Always speak to your GP or specialist before deciding to take part in a study.
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