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Study identifier: NCT04061512 Synced from ClinicalTrials.gov · July 28, 2026
● Recruiting

Rituximab and Ibrutinib (RI) Versus Dexamethasone, Rituximab and Cyclophosphamide (DRC) as Initial Therapy for Waldenström's Macroglobulinaemia

Condition: Waldenstrom Macroglobulinemia  ·  Sponsor: University College, London

PhasePhase 2/Phase 3
Planned participants148
Who can joinAll sexes, 18 Years to no upper limit
Healthy volunteersNo

About this study

Waldenström's macroglobulinaemia (WM) is a rare type of slow growing lymphoma. It develops when white blood cells grow abnormally. Typically a disease of the elderly, the median age of presentation is \>70 years and the current treatment for WM is unsatisfactory, with incomplete responses and inevitable recurrence. Therefore there is a need to find alternative treatments that are more effective, leading to lasting responses and improved quality of life. The RAINBOW study is a phase 2-3 trial assessing 'chemotherapy free' treatment as primary therapy for WM which can potentially improve response outcome, durability and importantly, reduce toxicity for WM patients. This approach will be done using the drug Ibrutinib, which in combination with rituximab (RI) will be the experimental arm. As there is no agreed standard on first-line therapy for WM, the control arm is the current treatment based on the most recently published clinical trial results. The control arm consists of rituximab, cyclophosphamide and dexamethasone (DCR), and is widely recommended by international consensus as appropriate treatment for first-line therapy for WM. In this study, 148 adults (aged ≥ 18 years) with treatment naïve WM will be randomised on a 1:1 ratio to either the treatment or control arm. Randomised treatment lasts for a maximum of 6 cycles and response will be assessed following 3 cycles of treatment and completion of randomised treatment at approximately 24 weeks after commencing treatmen…

This description comes directly from the study's public registry record.

Talk to the study team

RAINBOW Trial Coordinator  ·  020 7679 9711  ·  ctc.rainbow@ucl.ac.uk

UCL CTC haematology trials team  ·  020 7679 9860

Always discuss trial participation with your own doctor first.

Locations (25)

Royal United Hospital, BathBath, United KingdomRecruiting
The Royal Bournemouth and Christchurch Hospitals NHS Foundation TrustBournemouth, United KingdomRecruiting
East Kent Hospitals University NHS Foundation TrustCanterbury, United KingdomRecruiting
University Hospital of WalesCardiff, United KingdomRecruiting
Colchester HospitalColchester, United KingdomRecruiting
Mid Yorkshire NHS TrustDewsbury, United KingdomRecruiting
Royal Devon University HospitalExeter, United KingdomRecruiting
Medway Maritime HospitalGillingham, United KingdomRecruiting
Castle Hill HospitalHull, United KingdomRecruiting
NHS LanarkshireLanark, United KingdomRecruiting
St James's University HospitalLeeds, United KingdomRecruiting
Leicester Royal InfirmaryLeicester, United KingdomRecruiting

+ 13 more locations — full list on the registry record.

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Source record: clinicaltrials.gov/study/NCT04061512