Efficacy and Safety of Orelabrutinib Combined With Rituximab Versus Lenalidomide Combined With Rituximab in Patients With Relapsed/Refractory Marginal Zone Lymphoma

Inclusion criteria

• Age ≥ 18 years , either sex.
• Histopathologically confirmed B-cell non-Hodgkin lymphoma MZL (splenic, nodal, or extra-nodal).
• Prior systemic therapy including at least one anti-CD20 monoclonal antibody-containing regimen is required, with the following specifications:

For combination therapies: Minimum of 2 completed treatment cycles For anti-CD20 monotherapy: Minimum of 4 administered doses Progression during treatment waives cycle/dose requirements

• Relapsed or refractory disease.
• At least 1 measurable lesion confirmed through enhanced computed tomography (CT) or enhanced magnetic resonance imaging (MRI).
• ECOG performance status (PS) score of 0-2.

Exclusion criteria

• Administration of the specified anti-tumor therapies within 2 weeks prior to the first dose of the study treatment.
• Administration of any other investigational product within 4 weeks prior to the first dose of the study treatment, or concurrent participation in another clinical trial.(Excluding patients who have discontinued treatment and are in long-term follow-up).
• Prior treatment with any types of BTK inhibitor.
• Patients refractory to lenalidomide plus rituximab (R2 regimen). Refractoriness is defined as either: Failure to achieve at least partial response (PR) after completing an adequate R2 treatment course (≥2 cycles at standard doses), OR Disease progression during R2 therapy or within 6 months after the last dose.
• Central nervous system (CNS) lymphoma, and lymphoma with CNS or meningeal involvements.