A Multicenter, Randomized, Double-blind, Placebo-controlled Phase 3 Study of the Bruton’s Tyrosine Kinase (BTK) Inhibitor, Ibrutinib, in Combination with Rituximab versus Placebo in Combination with Rituximab in Treatment Naïve Subjects with Follicular Lymphoma
This research study is for people in the UK who have follicular lymphoma, which is a type of blood cancer that affects certain white blood cells. This study is testing a new drug called Ibrutinib. Researchers want to see if combining Ibrutinib with another standard drug, Rituximab, is more effective than just Rituximab alone. Participants will be randomly assigned to one of two groups: one group will receive Ibrutinib plus Rituximab, and the other will receive a dummy drug (placebo) plus Rituximab. The main goal is to find out if the Ibrutinib combination helps people live longer without their cancer getting worse, and to understand any side effects. This is a crucial step in finding better treatments for follicular lymphoma.
At a glance
What is this study about?
This research study, called a clinical trial, is looking for a better way to treat follicular lymphoma. This is a type of cancer that starts in certain white blood cells called lymphocytes. When you're first diagnosed with follicular lymphoma and haven't had treatment before, doctors look for the best treatment to help you.
In this study, they are investigating a new drug called Ibrutinib. This drug works by targeting a specific protein in the cancer cells. The researchers want to see if adding Ibrutinib to a standard treatment, Rituximab, is more effective than the standard treatment alone. Rituximab is a common treatment for follicular lymphoma that helps your immune system fight the cancer cells.
The main aim is to find out if people who receive Ibrutinib along with Rituximab live longer without their cancer growing or getting worse. This is an important measure because it tells us how well the treatment is controlling the cancer. The study will also carefully check for any side effects and how people feel overall. By understanding these results, doctors can make better decisions about future treatments for follicular lymphoma.
Key takeaways
- This study is for people with newly diagnosed follicular lymphoma.
- It's comparing a new drug (Ibrutinib) with a standard treatment (Rituximab).
- The main goal is to see if Ibrutinib helps people live longer without their cancer worsening.
- Participants will be randomly assigned to one of two treatment groups.
- All study visits and treatments will be provided by the research team.
- You can stop participating at any time you wish.
Who may be eligible?
This study is looking for adults who are at least 18 years old. Both men and women can take part.
To be eligible, you must have been recently diagnosed with follicular lymphoma and have not yet received any treatment for it. This is important because the study wants to see how the new treatment works in people who are just starting their cancer journey.
There will be other detailed health checks to make sure the study is safe and suitable for you. These will be discussed with you by the study doctor or nurse to see if you meet all the requirements.
- Are you 18 years old or older?
- Have you been diagnosed with follicular lymphoma?
- Have you NOT received any treatment for your follicular lymphoma yet?
- Are you able to take capsules by mouth?
- Are you willing to attend regular hospital or clinic visits?
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 randomly placed into one of two groups. Neither you nor your doctor will know which group you are in. One group will receive the new drug Ibrutinib along with Rituximab, and the other group will receive a dummy pill (placebo) along with Rituximab. The Ibrutinib or placebo is a capsule you take by mouth.
You will have regular visits to the hospital or clinic for treatments, check-ups, and to monitor how you are doing. These visits will involve blood tests, physical examinations, and possibly scans to see how your cancer is responding and to check for any side effects. The study also looks at how long the treatment keeps the cancer under control.
The exact length of your participation will depend on how you respond to the treatment and the study's design. The study team will explain the full schedule of visits and assessments to you before you agree to take part.
Potential risks and benefits
Locations (11)
- —Italy
- —Greece
- —Austria
- —Netherlands
- —Hungary
- —Czechia
- —Poland
- —Belgium
- —Spain
- —Portugal
- —France
Common questions
What is Ibrutinib?
Ibrutinib is a new drug being tested that aims to block a specific protein involved in the growth of follicular lymphoma cells.
What is a 'placebo'?
A placebo is a dummy pill that looks exactly like the study drug but contains no active medicine. It helps researchers compare the effects of the active drug.
Will I know which treatment I'm getting?
No, this is a 'double-blind' study, meaning neither you nor your doctors will know if you're getting Ibrutinib or the placebo. This helps ensure fair and unbiased results.
What does 'progression-free survival' mean?
It's a way for doctors to measure how long people live without their cancer getting worse or growing. It helps measure how effective a treatment is at controlling the cancer.
Can I leave the study if I change my mind?
Yes, absolutely. Your participation is completely voluntary, and you can withdraw from the study at any time without having to give a reason.
How to find out more
Always speak to your GP or specialist before deciding to take part in a study.
Discussion
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