Study identifier: NCT05735834 Synced from ClinicalTrials.gov · August 05, 2026
● Active Not Recruiting

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

Condition: Splenic Marginal Zone Lymphoma  ·  Sponsor: International Extranodal Lymphoma Study Group (IELSG)

PhasePhase 3
Planned participants122
Who can joinAll sexes, 18 Years to no upper limit
Healthy volunteersNo

About this study

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.

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

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No contact information is available for this study as per the public registry record.

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Locations (49)

Medical University of ViennaVienna, Austria
Institut BergoniéBordeaux, France
CHU de GrenobleGrenoble, France
Hôpital Saint LouisParis, France
Hôpital Lyon-SudPierre-Bénite, France
CHRU Nancy BraboisVandœuvre-lès-Nancy, France
IRCCS Istituto Tumori Giovanni Paolo IIBari, Italy
IRCCS AOU di BolognaBologna, Italy
ASST Spedali Civili di BresciaBrescia, Italy
A.O.U. Policlinico G. Rodolico-S. MarcoCatania, Italy
IRCCS IRST Istituto Romagnolo per lo Studio dei Tumori "Dino Amadori"Meldola, Italy
Fondazione IRCCS Ca' Granda Ospedale Maggiore PoliclinicoMilan, Italy

+ 37 more locations — full list on the registry record.

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