Clinical Trial

Comparison Between Rituximab Plus Zanubrutinib Versus Rituximab Monotherapy in Untreated SMZL Patients

Study acronym: RITZ
Active, Not Recruiting Phase 3
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Summary
The goal of this clinical trial is to compare the efficacy and tolerability of the combination of two medicinal products, rituximab, and zanubrutinib, compared to rituximab monotherapy in patients with Splenic Marginal Zone Lymphoma (SMZL), previously untreated and who need systemic treatment. The main questions it aims to answer are: * Is the combination rituximab and zanubrutinib a more effective therapy than rituximab monotherapy? * Is the combination therapy, rituximab and zanubrutinib, well tolerated? Study participants will be put into one of the two treatment groups (rituximab and zanubrutinib or rituximab alone) for a maximum of two years and will undergo regular visits until three years from treatment start.
Protocol Amendment History 21 amendments
This ClinicalTrials.gov record has been amended 21 times since 2023-02-17; most recent amendment 2026-07-21.
Status change: Recruiting → Active, Not Recruiting 2026-01-14
Status change: Not Yet Recruiting → Recruiting 2024-05-17
Trial Details
NCT Number NCT05735834
Lead Sponsor International Extranodal Lymphoma Study Group (IELSG)
Conditions Splenic Marginal Zone Lymphoma
Enrollment 122 participants
Start Date 2024-05-21
Primary Completion 2029-05 (estimated)
Study Completion 2029-05 (estimated)
Updated on ClinicalTrials.gov 2026-07-22