IELSG48

IELSG48Phase 3, interventional, multicentre, open-label, randomized study comparing rituximab plus zanubrutinib to rituximab monotherapy in previously untreated, symptomatic splenic marginal zone lymphoma (RITZ)
Participants required:120
Investigator responsible(s):D. Rossi
Objective(s):The objectives of this trial are: to evaluate the efficacy of the addition of zanubrutinib to rituximab versus rituximab monotherapy in subjects with previously untreated SMZL in terms of Progression-Free Survival (PFS), to evaluate the activity of the addition of zanubrutinib to rituximab vs rituximab monotherapy in subjects with previously untreated SMZL in terms of Overall Response Rate (ORR), Duration of Response (DoR), and Overall Survival (OS), and to evaluate the safety profile of the addition of zanubrutinib to rituximab versus rituximab monotherapy in subjects with previously untreated SMZL.
Lay summary:Splenic marginal zone lymphoma (SMZL) is a slow-growing tumor affecting B lymphocytes, a type of white blood cell.
Recommended treatments usually include rituximab alone or spleen removal. Rituximab plus chemotherapy, although effective, has more side effects.
The clinical trial evaluates whether zanubrutinib (a drug that blocks uncontrolled proliferation of the tumor cells) plus rituximab is more effective and safer than rituximab alone for treating SMZL.
This randomized trial is enrolling 120 participants to receive either the combination or rituximab alone.
Eligibility requires untreated SMZL, good general health, and adherence to contraceptive guidelines.

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