A Phase 3b, Multicenter, Open-Label, Single-Arm Study of Acalabrutinib (ACP-196) in Subjects with Chronic Lymphocytic Leukemia
This study is for people with chronic lymphocytic leukemia (CLL) and it's looking at a medicine called Calquence (acalabrutinib). The main goal is to carefully track any side effects patients might have, how serious they are, and if they're related to the medicine. This includes looking for more serious side effects, those that make someone stop treatment, and specific health issues like heart problems or infections. Researchers will also be checking how well people respond to the treatment, how long that response lasts, and how long people live without their disease getting worse. It's an open-label study, meaning everyone knows what medicine they are taking.
At a glance
What is this study about?
This study is about a kind of blood cancer called chronic lymphocytic leukemia, or CLL. Researchers are testing a medicine named Calquence (acalabrutinib) to see how it affects people with this condition. Imagine the study as a careful check-up to understand the medicine better. Everyone in this study will receive the Calquence medicine.
The main thing the doctors want to find out is how safe Calquence is. They will be keeping a very close eye on any health problems (doctors call these 'side effects') that people might experience while taking the medicine. They'll record how often these side effects happen, how serious they are, and if they seem to be caused by the medicine itself. This includes looking for more significant health concerns, such as heart issues, liver problems, or infections, and also checking if any side effects are serious enough to make someone stop taking the medicine.
Beyond safety, the study also aims to understand how well Calquence works. They will check if the cancer shrinks or goes away (doctors call this 'overall response'). They'll also find out how long people stay healthy without their cancer growing or spreading, and how long the medicine helps keep the cancer in check. This information helps doctors understand if Calquence is an effective and safe treatment option for CLL.
Key takeaways
- The study is investigating a medicine called Calquence for chronic lymphocytic leukemia.
- The main goal is to understand the safety of Calquence by tracking side effects.
- Researchers will also see how well the medicine helps patients.
- Participation involves taking Calquence capsules and having regular medical check-ups.
- All adults (18 years and older) with CLL may be eligible.
- You can stop participating at any time.
Who may be eligible?
To join this study, you need to be an adult, 18 years old or older. There is no upper age limit, meaning older adults can also take part.
This study is for both men and women.
While the basic requirements are flexible regarding age and sex, there will be other important health checks to make sure the study is a good fit for you. For example, doctors will need to confirm you have chronic lymphocytic leukemia and that you meet certain other health standards to ensure the medicine can be given safely.
- Am I 18 years old or older?
- Do I have chronic lymphocytic leukemia?
- Am I able to visit the clinic regularly for appointments?
- Am I able to take medicine in capsule form?
This is a guide only — the research team will confirm whether you can take part.
What does participation involve?
If you join this study, you would primarily be taking the study medicine, Calquence, which comes as 100 mg hard capsules. You would take these capsules as instructed by the study doctors. Throughout the study, you would have regular visits to the clinic. During these visits, doctors and nurses will perform various assessments. This includes physical check-ups, blood tests, and other tests to monitor your health and how you're responding to the medicine. They will also carefully record any side effects you experience. The duration of your participation would depend on how you respond to the treatment and your tolerability to the medicine, but you would continue as long as the treatment is benefiting you and you are not experiencing unacceptable side effects.
Potential risks and benefits
Locations (9)
- —Norway
- —Sweden
- —Denmark
- —Spain
- —Netherlands
- —Germany
- —Finland
- —Italy
- —France
Common questions
What is chronic lymphocytic leukemia (CLL)?
CLL is a type of cancer that affects your blood and bone marrow, which are parts of your body that make blood cells. It causes your body to make too many abnormal white blood cells.
What is Calquence?
Calquence (acalabrutinib) is the name of the medicine being studied. It comes in capsule form.
What does 'single-arm study' mean?
A 'single-arm study' means everyone in the study will receive the same medicine, Calquence. There isn't a comparison group taking a different medicine or a placebo.
What kind of side effects are they looking for?
The study team will look for all kinds of side effects, including common ones, more serious events, and specific issues like heart problems, infections, or stomach bleeding.
Will this medicine cure my cancer?
This study aims to see how well the medicine works and if it helps in treating CLL, but it's important to talk to your doctor about your specific condition and what to expect from treatments.
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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