Efficacy and Safety of Orelabrutinib Plus Lenalidomide and Rituximab (R2) Compared to Placebo Plus R2 in r/r Marginal Zone Lymphoma

Inclusion Criteria:

1. Age ≥ 18 years and ≤ 80 years, either sex.

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

3. At least one and no more than 3 prior lines of systemic therapy (CD20 targetedtherapy included in at least one line).

4. Relapsed or refractory disease.

5. At least 1 measurable lesion confirmed through enhanced computed tomography (CT) orenhanced 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 thefirst dose of the study treatment.

2. Administration of any other investigational product within 4 weeks prior to thefirst dose of the study treatment, or concurrent participation in another clinicaltrial.

3. Prior treatment with any types of BTK inhibitor.

4. Prior allogeneic hematopoietic stem cell transplantation (Allo-HSCT), or Autologoushematopoietic stem cell transplantation (ASCT) within 6 months prior to the firstdose of the study treatment; or prior CAR-T cell therapy.

5. Central nervous system (CNS) lymphoma, and lymphoma with CNS or meningealinvolvements.