This study focuses on treatment-naïve marginal zone lymphoma (MZL) patients and aims to investigate the efficacy and safety of orelabrutinib combined with or without CD20 monoclonal antibody.
This is a single-arm study without a control group. All subjects will receive orelabrutinib treatment but will be stratified based on disease stage and clinical characteristics into the following two groups:
1. Stage I MZL Patient Group (Monotherapy Group) Treatment regimen: Orelabrutinib monotherapy. Dosage and administration: Orelabrutinib 150mg, once daily (qd), taken continuously for 21 days per treatment cycle (d1-d21), for a total of 6 cycles (C1-C6).
Target population: Patients with Ann Arbor Stage I gastric MALT MZL, including H. pylori-negative patients or those with unsatisfactory response after anti-H. pylori therapy, as well as other Stage I MZL patients unsuitable for local radiotherapy.
Sample size: 50 cases. 2. Stage II-IV MZL Patient Group (Combination Therapy Group) Treatment regimen: Orelabrutinib combined with a CD20 monoclonal antibody. Dosage and administration: Orelabrutinib 150mg, once daily (qd), taken continuously for 21 days per treatment cycle (d1-d21), for a total of 6 cycles (C1-C6). CD20 monoclonal antibody (either Rituximab 375mg/m², intravenous infusion, Day 1 of each cycle, C1-C6; or Obinutuzumab 1000mg, intravenous infusion, on Days 1, 8, and 15 of Cycle 1 \[C1\], and on Day 1 of Cycles 2-6 \[C2-C6\]).
Target population: Patients with Ann Arbor Stage II-IV non-gastric MALT MZL, nodal MZL, splenic marginal zone lymphoma (SMZL), and other Stage II-IV MZL patients unsuitable for local radiotherapy.
Sample size: 38 cases.
Age ≥ 18 years;
Pathologically confirmed marginal zone lymphoma;
Presence of evaluable lesions;
Meets indications for treatment: Fulfills the GELF criteria OR has disease-related clinical symptoms/organ function impairment;
Currently diagnosed with another malignant tumor;
Central nervous system involvement by lymphoma or transformation to a higher grade;
Allergy to any of the investigational drugs;
Active infection or uncontrolled HBV infection, HIV/AIDS, or other serious infectious diseases;
Single group
Orelabrutinib
Drug1. Stage I MZL Patients: Treatment with Orelabrutinib monotherapy. Induction Phase: During Cycles 1-6 (C1-C6), Orelabrutinib 150mg is administered orally once daily (qd) on Days 1-21 (d1-d21) of each cycle. 2. Stage II-IV MZL Patients: Treatment with the Orelabrutinib plus CD20 monoclonal antibody regimen, divided into an induction phase and a maintenance phase. Induction Phase: During Cycles 1-6 (C1-C6), Orelabrutinib 150mg is administered orally once daily (150mg qd d1-d21/C1-C6). Concurrently, a CD20 monoclonal antibody is used: either Rituximab 375mg/m² intravenously (iv) on Day 1 of each cycle (d1/C1-C6); or Obinutuzumab, administered as 1000mg intravenously on Days 1, 8, and 15 of Cycle 1 (1000mg iv d1,d8,d15/C1), followed by 1000mg intravenously on Day 1 of Cycles 2-6 (1000mg iv d1/C2-C6). Maintenance Phase: If maintenance therapy is administered, during Cycles 7-30 (C7-C30), Orelabrutinib 150mg is administered orally once daily (qd) on Days 1-28 (d1-d28) of each cycle.
Overall Response Rate
Best Overall Response Rate (ORR): Efficacy is assessed every two treatment cycles. The best ORR achieved within the 6 treatment cycles serves as the primary endpoint.
Complete Response Rate
Best Complete Response Rate (CRR): Efficacy is assessed every two treatment cycles. The best CRR achieved within the 6 treatment cycles serves as a secondary endpoint.
2-Year Progression-Free Survival Rate
2-Year PFS (Progression-Free Survival) refers to the time interval from the date a patient begins treatment until either disease progression, relapse, or death from any cause reaches two years. If the patient does not experience disease progression and remains alive within the two-year period, they are considered to have achieved 2-year PFS. If disease progression or death occurs within the two years, 2-year PFS is not achieved.
2-Year Overall Survival Rate
2-Year Overall Survival Rate (OS): OS is defined as the time from the date of study enrollment until the patient dies from any cause or is lost to follow-up.
AE
Safety is evaluated according to the CTCAE v5.0 criteria. Toxicity assessments are performed during each treatment cycle, primarily focusing on hematological toxicities and non-hematological toxicities.
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