An Open-label, Phase 2 Study of ACP-196 (Acalabrutinib) in Subjects With Mantle Cell Lymphoma

To join this study, you need to be at least 18 years old and have Mantle Cell Lymphoma that has been officially confirmed by doctors. This is for people whose cancer has either come back after past treatments or didn't respond to at least one (but not more than five) previous treatments.

You would also need to be generally well enough to take part, meaning you can do most normal daily activities. If you are sexually active and could have children, you would need to agree to use contraception during the study and for 30 days after taking the last dose of the study medicine.

However, you couldn't join if you have other serious health problems, such as certain heart conditions, or if you have severe issues with your digestive system that might stop the medicine from working properly. You also can't take part if you are pregnant or breastfeeding.

If you join this study, you would take one 100mg tablet of acalabrutinib twice a day, every day. This continues in cycles, where each cycle lasts 28 days. You would keep taking the medicine as long as it's helping and you're not having serious side effects.

Before you start, you'll have some initial health checks, including blood and urine tests. Once you start taking the medicine, you'll have frequent check-ups. For the first month, you'll have weekly safety checks, then every two weeks in the second month, and then once a month for the next ten months. After that, checks will be every 24 weeks.

During these visits, you'll have more blood tests to check how your body is handling the medicine and how much of it is in your system. Doctors will also regularly check your cancer to see how it's responding to the treatment. There might be a number of hospital visits in total, especially at the beginning.