Rituximab and Ibrutinib (RI) versus Dexamethasone, Rituximab and Cyclophosphamide (DRC) as Initial Therapy for Waldenström’s Macroglobulinaemia (RAINBOW)

Is ibrutinib and rituximab a more effective first-line treatment than the current standard first-line treatment for people with WM?

Main Aims

This study is a randomised trial (patients are put into groups at random, not by choice), comparing two different treatments.
One group of patients receive a standard first line treatment for WM – dexamethasone, rituximab and cyclophosphamide (DRC) – whilst the other receive a ‘chemotherapy-free’ treatment of Ibrutinib (a BTK inhibitor) and rituximab.
The aim of the study is to see if the ‘chemotherapy-free’ treatment which is not currently available as a first-line treatment is more effective and less toxic for patients.

Recruitment Criteria

• Confirmed diagnosis of WM

• You have not received treatment for WM before

• You have had no previous chemotherapy for any disease

Recruitment status: Recruiting

Sponsor: University College London

Expected to end: 01/03/2030

Phases: Phase 2, Phase 3

Regions: East Midlands, East of England, England, London, North West England, South East, South East England, South West, South West England, Wales, Yorkshire and the Humber