Acalabrutinib and Rituximab in Previously Untreated Mantle Cell Lymphoma

This study is looking for men and women aged 60 or older who have Mantle Cell Lymphoma. You must have been recently diagnosed and not yet had treatment for your lymphoma (unless it was for symptom relief or very localised radiotherapy).

You might be suitable if your doctors think you're not strong enough for the usual intensive chemotherapy. This could be because you're over 80, have other significant health problems (like heart or lung conditions), or generally feel less fit. We need to make sure the treatment is right for you, so your doctors will assess your overall health and fitness using specific checks.

To join, you'll need to be able to swallow tablets and be willing to attend all study appointments and follow the treatment plan. If you are a woman who could become pregnant, you'll need to have a negative pregnancy test and agree to use effective contraception during the study.

If you decide to take part, you'll be one of 48 patients across 12 different hospitals in the UK.

**Intervention:** You will receive two medicines: acalabrutinib, which you'll take as a tablet twice a day, and rituximab, which will be given as a drip into your arm (intravenous) on the first day of each cycle. After the first cycle, rituximab might also be given as an injection under the skin (subcutaneous). You'll receive these two drugs together for up to six 'cycles' of treatment. Each cycle lasts 28 days. After six cycles, if the treatment is working, you will continue taking acalabrutinib tablets twice a day on their own.

**Assessments:** You'll have regular hospital visits for blood tests, physical exams, and scans to see how you're responding to the treatment and to check for any side effects.

**Follow-up:** We will keep in touch with you for at least two years after you finish your main treatment, to see how you are doing in the long term.

**Total Duration:** The active treatment phase with both drugs lasts up to six months. If you continue on acalabrutinib, you'll take it until your doctor advises otherwise, or if your cancer gets worse, or if you experience side effects.