RAINBOW: a randomised, phase 2/3 trial comparing ibrutinib plus rituximab with standard treatment in people with Waldenström’s macroglobulinaemia
This trial is comparing ibrutinib plus rituximab with standard treatment (dexamethasone, rituximab and cyclophosphamide) in people with Waldenström’s macroglobulinaemia who haven’t been treated before.
Trial aim and background
The aim of this trial is to find out whether chemotherapy-free treatment with ibrutinib plus rituximab is more effective and safer than standard treatment for people with Waldenström’s macroglobulinaemia who haven’t been treated before.
Participants are randomly allocated to have one of two treatments:
- ibrutinib plus rituximab
- dexamethasone, rituximab and cyclophosphamide (DRC).
Ibrutinib is a type of targeted drug called a BTK inhibitor. It blocks signals that encourage lymphoma cells to grow. It is already available to treat Waldenström’s macroglobulinaemia that has come back (relapsed) or not responded (refractory) to initial treatment.
DRC is standard treatment for people with Waldenström’s macroglobulinaemia who haven’t been treated before.
Rituximab is an antibody therapy that sticks to a protein called CD20 on lymphoma cells. This attracts immune cells, which can kill the lymphoma cells. It is routinely used to treat many types of lymphoma, including Waldenström’s macroglobulinaemia.
Who can enter
Adults with Waldenström’s macroglobulinaemia which requires treatment, but have not yet received any may be eligible for this trial.
Locations
- Royal United Hospital, Bath
- The Royal Bournemouth and Christchurch Hospitals NHS Foundation Trust, Bournemouth
- East Kent Hospitals University NHS Foundation Trust, Canterbury
- University Hospital of Wales, Cardiff
- Colchester Hospital, Colchester
- Mid Yorkshire NHS Trust, Dewsbury
- Royal Devon University Hospital, Exeter
- Castle Hill Hospital, Hull
- NHS Lanarkshire, Lanark
- Leicester Royal Infirmary, Leicester
- Barking, Havering and Redbridge University Hospitals NHS Trust, London
- Barts Health NHS Trust, London
- King's College Hospital, London
- University College London Hospitals NHS Foundation Trust, London
- Christie NHS Foundation Trust, Manchester
- Norfolk and Norwich Hospital, Norwich
- Oxford University Hospital, Oxford
- University Hospitals Plymouth NHS Trust, Plymouth
- Torbay & Newton Abbot Hospital, Torquay
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/study/NCT04061512
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.