Phase 3, interventional, multicentre, open-label, randomized study comparing rituximab plus zanubrutinib to rituximab monotherapy in previously untreated, symptomatic splenic marginal zone lymphoma (RITZ)

Research summary

IELSG48 is a Phase III,interventional,multicenter,open label,randomized study to evaluate whether treatment with zanubrutinib in combination with rituximab will result in an improvement in PFS compared to treatment with rituximab in patients with previously untreated SMZL. Approximately 120 subjects will be randomized in a 1:1 ratio to receive zanubrutinib and rituximab Treatment Arm A) or rituximab (Treatment Arm B). The study will include a Screening Phase,a Treatment Phase,and a Follow-Up Phase. Subjects with investigator-confirmed progressive disease according to the Lugano 2014 criteria or unacceptable toxicity,or investigator/subject decision must discontinue study treatment. Patients who complete the treatment and patients who will discontinue treatment for any reason will enter the Follow-up Phase. The Response Follow-up Phase will occur for subjects who complete the treatment or discontinue for reasons other than disease progression and will include efficacy assessments every 24 weeks until investigator-assessed disease progression. Subjects with PD during the Response Follow-up Phase will continue to be followed in the Survival Follow-up Phase. An Independent Data Monitoring Committee (IDMC) will be responsible for an independent review of the interim safety analysis on the first 20 enrolled patients in the experimental arm.

Principal Investigator

Dr Danmei Xu

Contact us

Email: Latephasehaematology@ouh.nhs.uk

IRAS number

1005891