A Study of Acalabrutinib vs Investigator's Choice of Idelalisib Plus Rituximab or Bendamustine Plus Rituximab in R/R CLL
This research study is for people in the UK aged 18 and over who have chronic lymphocytic leukaemia (CLL) that has either come back after treatment or didn't get better with previous treatments. The study aims to compare a new medicine, acalabrutinib, with standard treatments like rituximab combined with either idelalisib or bendamustine. Researchers want to find out if acalabrutinib is more effective at treating CLL than these established options. It's a Phase 3 study, meaning it's a large trial testing if a new treatment is better than, or as good as, current treatments.
At a glance
What is this study about?
This study is designed for individuals in the UK living with a type of blood cancer called chronic lymphocytic leukaemia (CLL). CLL affects white blood cells, and sometimes it doesn't respond to initial treatment, or it comes back after a period of improvement. For these people, doctors need more options.
The main goal of this particular study is to explore a new treatment called acalabrutinib. Researchers want to see how well it works compared to some existing treatment combinations that doctors often use for CLL when it returns or doesn't improve. These current treatments involve a medicine called rituximab, given alongside either idelalisib or bendamustine.
By comparing acalabrutinib with these standard options, the study hopes to find out if acalabrutinib is a better or equally good way to manage CLL. The information gathered from this study could help doctors in the future make more informed decisions about the best treatments for people with recurrent or hard-to-treat CLL.
Key takeaways
- This study is for adults with CLL that needs new treatment.
- It aims to compare a new drug, acalabrutinib, with existing treatments.
- Participation involves regular clinic visits and health checks.
- You might receive the new medicine or a standard combination medicine.
- This is a Phase 3 study, meaning it's a larger trial to compare treatments.
Who may be eligible?
To be part of this study, you need to be an adult aged 18 or older and have a confirmed diagnosis of chronic lymphocytic leukaemia (CLL). Importantly, your CLL needs to be active, meaning it's causing problems that require treatment, or it has come back after you've had treatment before.
Your doctors would need to confirm that your CLL meets specific criteria. For example, they'll check your blood for certain types of cells and how many there are. They'll also make sure your general health is good enough to take part, based on a standard health score. Your CLL must also show traces of a specific marker called CD20.
You would not be able to join if your CLL is causing severe anaemia (low red blood cells), low platelets (cells that help blood clot), an enlarged spleen or lymph nodes that are growing quickly or causing symptoms, or if your white blood cell count is rapidly increasing. There are other detailed medical conditions that your study doctor will check very carefully to make sure the study is right and safe 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?
- Have you been diagnosed with Chronic Lymphocytic Leukaemia (CLL)?
- Has your CLL come back after treatment, or is it not responding to past treatments?
- Is your doctor recommending treatment for your active CLL?
- Is your general health good enough to take part in a clinical study?
What does participation involve?
If you decide to take part in this study, you would receive either the new medicine, acalabrutinib, or one of the standard treatments (rituximab with idelalisib, or rituximab with bendamustine). Which treatment you receive would be decided by chance, like flipping a coin. You would have regular visits to the clinic for medical check-ups, blood tests, and to get your study medicine. These visits would help the doctors keep a close eye on your health and how you're responding to the treatment. The total duration for which you would stay on the study treatment would depend on how your CLL responds, but you would have regular follow-up even after stopping the treatment.
Potential risks and benefits
Locations (157)
- Research SiteVerified postcodeChandler, United States
- Research SiteVerified postcodeOxnard, United States
- Research SiteVerified postcodeAthens, United States
- Research SiteVerified postcodeJoliet, United States
- Research SiteVerified postcodeCedar Rapids, United States
- Research SiteVerified postcodeMount Sterling, United States
- Research SiteVerified postcodeSaint Cloud, United States
- Research SiteVerified postcodeLincoln, United States
- Research SiteVerified postcodeBrick, United States
- Research SiteVerified postcodeNyack, United States
- Research SiteVerified postcodeCanton, United States
- Research SiteVerified postcodeFort Sam Houston, United States
Common questions
What is chronic lymphocytic leukaemia (CLL)?
CLL is a type of blood cancer that affects white blood cells called lymphocytes. It usually progresses slowly.
What is acalabrutinib?
Acalabrutinib is a newer medicine being tested to treat CLL. It works by targeting specific proteins involved in the growth of CLL cells.
Why is this study comparing treatments?
The study compares different treatments to see which one works best or has fewer side effects for people whose CLL has returned or not responded to previous treatments.
Will I know which treatment I'm getting?
In this type of study, it's decided by chance (like a lottery) which treatment you receive. Your study doctor will explain this in full detail.
What does 'R/R CLL' mean?
It means your CLL is 'Relapsed/Refractory' – meaning it has come back after treatment or hasn't responded to previous treatments.
How to find out more
Always speak to your GP or specialist before deciding to take part in a study.
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