BRUIN-MCL-321: A phase 3 trial of a targeted treatment called pirtobrutinib in people with relapsed or refractory mantle cell lymphoma
A phase 3 trial comparing pirtobrutinib with other similar treatments in people with mantle cell lymphoma that has come back or not responded after at least one previous course of treatment.
Trial aim and background
The aim of this trial is to compare the efficacy of pirtobrutinib with existing drugs of the same type in people with relapsed or refractory mantle cell lymphoma.
People who take part in this trial are randomly allocated to one of two treatment groups:
- Group 1 have pirtobrutinib (also known as LOXO-305).
- Group 2 in the UK have ibrutinib. (People in group 2 in other countries might have ibrutinib, acalabrutinib or zanubrutinib.)
You can’t choose which group you are in and neither can your doctor. You are told which treatment you are having and given information about it.
Pirtobrutinib, ibrutinib, acalabrutinib and zanubrutinib are all targeted treatments that block a protein called ‘BTK’ on B cells (the type of white blood cells that become abnormal in B-cell lymphomas). BTK is part of a pathway that helps B cells to stay alive and divide. Blocking BTK can make B cells die or prevent them dividing. Pirtobrutinib, ibrutinib, acalabrutinib and zanubrutinib are tablets taken by mouth every day.
Whichever treatment you are on, you may carry on taking it for 2 years or more, unless your lymphoma gets worse or you develop troublesome side effects.
Who can enter
Adults with mantle cell lymphoma who have had one previous treatment regimen may be eligible for this trial.
Locations
Recruitment is taking place in the following UK locations:
- Genesis Care Cambridge, Newmarket
- City Hospital, Nottingham
- Derriford Hospital, Plymouth
- Genesis Care, Windsor
- New Cross Hospital, Wolverhampton
- Aberdeen Royal Infirmary, Aberdeen
- Churchill Hospital, Headington
- Beatson West of Scotland Cancer Centre, Glasgow
- Royal Marsden Hospital, Sutton
Further information
More information about what treatments are involved, the criteria you must meet in order to take part in the trial and where this trial is taking place are available at: https://clinicaltrials.gov/ct2/show/NCT04662255
Lymphoma Action are not able to refer people to specific trials. If you are interested in taking part in this trial we recommend that you print the trial summary and discuss it with your medical team. They can advise you on whether you might be eligible for the trial and how you can take part based on your individual circumstances.