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

A Randomized, Controlled, Open-label, Phase 3 Clinical Trial to Evaluate the Efficacy and Safety of Orelabrutinib Plus Rituximab Versus Lenalidomide Plus Rituximab in Relapsed/Refractory Marginal Zone Lymphoma

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

Inclusion Criteria:

1. Age ≥ 18 years , either sex.

2. Histopathologically confirmed B-cell non-Hodgkin lymphoma MZL (splenic, nodal, or extra-nodal).

3. 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

4. Relapsed or refractory disease.

5. At least 1 measurable lesion confirmed through enhanced computed tomography (CT) or enhanced magnetic resonance imaging (MRI).

6. ECOG performance status (PS) score of 0-2.

Exclusion Criteria:

1. Administration of the specified anti-tumor therapies within 2 weeks prior to the first dose of the study treatment.
2. 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).
3. Prior treatment with any types of BTK inhibitor.
4. 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.
5. Central nervous system (CNS) lymphoma, and lymphoma with CNS or meningeal involvements.