OncoMatch/Clinical Trials/NCT04061512
Rituximab and Ibrutinib (RI) Versus Dexamethasone, Rituximab and Cyclophosphamide (DRC) as Initial Therapy for Waldenström's Macroglobulinaemia
Is NCT04061512 recruiting? Yes, currently enrolling (May 2026). This Phase 2/3 trial studies multiple treatments including Dexamethasone, cyclophosphamide, rituximab and Rituximab, ibrutinib for waldenstrom macroglobulinemia.
Treatment: Dexamethasone, cyclophosphamide, rituximab · Rituximab, ibrutinib — 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 treatment. RI patients may then have up to 5 years of Ibrutinib monotherapy. Patients will be seen regularly during treatment and then every 3 months for 5 years after treatment discontinuation. Patients will enter annual follow up for survival until the end of trial (including progressed patients). The study will be conducted at NHS hospitals and is expected to last 9 years and 6 months.
Check if I qualifyExtracted eligibility criteria
Cancer type
Non-Hodgkin Lymphoma
Performance status
ECOG 0–2(Ambulatory, capable of self-care)
Prior therapy
Cannot have received: chemotherapy
Exception: prior plasma exchange and steroids are permissible
Cannot have received: any therapy for wm
Lab requirements
Blood counts
haematological suppression to Hb <10g/dl, or neutrophils <1.5x10^9/l or platelets <150x10^9/l (as criteria for initiating treatment)
Kidney function
creatinine clearance ≥ 30 ml/min as estimated by the Cockroft-Gault equation
Liver function
No chronic liver disease with hepatic impairment Child-Pugh class B or C
Cardiac function
No clinically significant cardiac disease (see exclusion criteria for details)
haematological suppression to Hb <10g/dl, or neutrophils <1.5x10^9/l or platelets <150x10^9/l; chronic liver disease with hepatic impairment Child-Pugh class B or C [excluded]; renal failure (creatinine clearance <30 ml/min as estimated by the Cockroft-Gault equation) [excluded]; clinically significant cardiac disease [excluded]
Structured fields extracted by AI. May contain errors — verify against the official protocol.
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