MedTrace Logo

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

NCT05735834 · Status: ACTIVE_NOT_RECRUITING · Phase: PHASE3 · Type: INTERVENTIONAL · Enrollment: 122

Last updated 2026-04-01

No results posted yet for this study

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.

Conditions

  • Splenic Marginal Zone Lymphoma

Interventions

DRUG

Rituximab

Truxima concentrate for solution for infusion 500 mg/50 ml

DRUG

Zanubrutinib

Zanubrutinib 80 mg hard capsules

Sponsors & Collaborators

  • International Extranodal Lymphoma Study Group (IELSG)

    lead OTHER

Principal Investigators

  • Davide Rossi, MD · Oncology Institute of Southern Switzerland - Bellinzona (Switzerland)

  • Emanuele Zucca, MD · International Extranodal Lymphoma Study Group (IELSG) - Bellinzona (Switzerland)

  • Luca Arcaini, MD · Fondazione IRCCS Policlinico San Matteo, Pavia, Italy

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
NONE
Model
PARALLEL

Eligibility

Min Age
18 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2024-05-21
Primary Completion
2029-05-31
Completion
2029-05-31

Countries

  • Austria
  • France
  • Italy
  • Norway
  • Spain
  • Sweden
  • Switzerland
  • United Kingdom

Study Locations

More Related Trials

Entities

Drugs

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT05735834 on ClinicalTrials.gov