Application of Orelabrutinib With or Without CD20 Monoclonal Antibody in Previously Untreated Marginal Zone Lymphoma

Condition(s) studied

Investigational drug(s) / intervention(s)

Orelabrutinib: 1. 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.

Study summary

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.

Eligibility

Primary outcome measure(s)

• Overall Response Rate — From enrollment to the end of treatment at 21 weeks
  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.

Trial sites (3)

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