CLL-Frail - A prospective, multicenter phase II trial of acalabrutinib in very old (≥80y) or frail CLL-Patients
This study, called CLL-Frail, is testing a new medicine called Calquence (acalabrutinib) for people who are 80 years old or more, or who are considered frail, and have a type of blood cancer called Chronic Lymphocytic Leukaemia (CLL). It's for those who are starting treatment for the first time or whose CLL has returned. We want to see how many people respond well to Calquence after about six months of treatment. Researchers will also be looking at how long people live, how long they stay free from their cancer getting worse, and if the treatment causes any side effects, especially in older patients like falls or confusion. This will help doctors understand if Calquence is a good option for this group of patients.
At a glance
What is this study about?
This research study, called CLL-Frail, is looking into a medication named Calquence (which is also known by its active ingredient, acalabrutinib). It's designed specifically for people with Chronic Lymphocytic Leukaemia (CLL), a type of blood cancer, who are either 80 years old or older, or who are considered to be frail. Frailty means someone might be weaker or have other health conditions that make treatment more challenging. The study includes people who are newly diagnosed and haven't had treatment for their CLL before, as well as those whose CLL has come back after previous treatment.
The main goal is to find out how many patients respond positively to Calquence after about six months of taking the medicine. 'Responding positively' means that the cancer shows signs of shrinking or improving. Researchers will also be keeping an eye on other important things, like how long people live, how long they stay free from their cancer getting worse, and how safe the medicine is for this specific group of patients. They are particularly interested in side effects that are more common in older people, such as falls or confusion, to make sure the treatment is as safe as possible.
Ultimately, this study aims to gather important information for doctors to help them decide if Calquence is a suitable and effective treatment option for older and frailer patients with CLL. Understanding how well the medicine works and what side effects it might have will help to improve care for these patients in the future.
Key takeaways
- The study is testing Calquence for older or frail patients with CLL.
- It's for people starting treatment or whose CLL has returned.
- The main goal is to see how well the medicine works after about six months.
- Researchers will also carefully check for side effects, especially those affecting older people.
- Participation involves taking daily medication and having regular health checks over about two years.
- You can stop participating at any time.
Who may be eligible?
This study is looking for adults aged 18 and older, both men and women, who have Chronic Lymphocytic Leukaemia (CLL). However, it specifically focuses on two groups: people who are 80 years old or older, and those who are considered frail, regardless of their exact age, because of other health concerns or their general health.
You might be able to join if you have CLL and haven't had any treatment for it yet. You could also be eligible if your CLL has come back after you've had treatment before. The medical team will check your overall health to see if this study is right for you, especially if you are in the older or frailer category.
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.
- Do you have Chronic Lymphocytic Leukaemia (CLL)?
- Are you 80 years old or older, or do your doctors consider you frail?
- Have you never had treatment for your CLL, or has your CLL come back after treatment?
- Are you able to take daily medication as tablets or capsules?
- Are you willing to attend regular hospital visits and check-ups?
What does participation involve?
If you decide to take part in this study, you would be given a medicine called Calquence, either as tablets or hard capsules, to take every day. You would have regular check-ups with the study team, likely involving blood tests and other examinations, to see how the treatment is working and to monitor your health. The first main check on how well the medicine is working will be around six months after you start.
After this initial check, you would continue to receive the medication and have follow-up visits. A final review of your cancer's response would happen around 24 months, or two years, after starting treatment. You'd also be monitored for how long you take the medicine, any changes to your dose, and for any side effects. The total duration of your participation, including follow-up, will be decided by the study team, but many of the main measurements occur over two years.
Potential risks and benefits
Locations (2)
- —UnverifiedAustria
- —UnverifiedGermany
Common questions
What is CLL?
CLL stands for Chronic Lymphocytic Leukaemia, which is a type of slow-growing cancer that affects white blood cells, called lymphocytes.
What is Calquence (acalabrutinib)?
Calquence is a medicine that targets certain proteins in your cancer cells to help stop them from growing and spreading.
What does 'frail' mean in this study?
Being 'frail' in this study doesn't necessarily mean you're very ill; it means your health might make certain treatments more challenging, and the study considers this carefully.
How long will I take the medicine?
You would take the medicine daily, and your response would be checked after about 6 months, and again after roughly 2 years.
Can I stop participating if I want to?
Yes, you can choose to leave the study at any time, for any reason, and it won't affect your future medical care.
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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