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This is a multicenter, real-world study on first-line CD20 monoclonal antibody-based regimens for treatment-naive marginal zone B-cell lymphoma based on risk stratification. The primary objective is to evaluate the efficacy and safety of the "BR", "R2", and "OR2" treatment regimens in treatment-naive MZL patients receiving first-line CD20 monoclonal antibody-based therapy stratified by risk.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| R2/BR/OR2 | For patients with low-risk marginal zone B-cell lymphoma (MZL-IPI score: 0-2 points), the "R2" regimen is preferred as the first-line treatment. If the patients are unable to tolerate or are not suitable for the R2 regimen, the "BR" regimen may be administered as an alternative.. For patients with high-risk marginal zone B-cell lymphoma (MZL-IPI score: 3-5 points), the "R2" or "OR2" regimen is administered for first-line treatment. |
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| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| R2/BR/OR2 | Drug | R2 regimen: 28-day cycle Rituximab was administered at a dose of 375 mg/m² via intravenous infusion on Day 1 of each cycle (Cycles 1-6); Lenalidomide was given orally at 20 mg per day from Day 1 to Day 21 of each cycle (Cycles 1-6). BR regimen: 28-day cycle Rituximab was administered at a dose of 375 mg/m² via intravenous infusion on Day 1 of each cycle (Cycles 1-6); Bendamustine was given via intravenous infusion at 70 mg/m² on Day 1 and Day 2 of each cycle (Cycles 1-6). OR2 regimen: 21-day cycle Rituximab was administered at a dose of 375 mg/m² via intravenous infusion on Day 1 of each cycle (Cycles 1-6); Lenalidomide was given orally at 20 mg per day from Day 2 to Day 11 of each cycle (Cycles 1-6); Orelabrutinib was administered orally at 150 mg per day for 2 years . |
| Measure | Description | Time Frame |
|---|---|---|
| Complete Response Rate(CRR) | The proportion of patients who achieved complete remission (CR) after the completion of treatment was evaluated in accordance with the revised criteria for the assessment of malignant lymphoma efficacy proposed at the 2014 Lugano Conference | up to 24 weeks |
| Measure | Description | Time Frame |
|---|---|---|
| 2-year progression-free survival (PFS) rate | The percentage of patients who remained alive and free of disease progression at 2 years after study entry, whichever occurred first | 2 years |
| 2-year overall survival (OS) rate |
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Inclusion Criteria:
Histologically confirmed marginal zone B-cell lymphoma (MZL) in accordance with the 2016 WHO classification;
Age ≥ 18 years, with no gender restriction;
Patients with MZL requiring systemic therapy, including but not limited to:
Gastric extranodal marginal zone lymphoma of mucosa-associated lymphoid tissue (MALT lymphoma), HP-positive or HP-negative, with progression/relapse after local therapy (including surgery, radiotherapy, and anti-Helicobacter pylori treatment);
Non-gastric MALT lymphoma:
Patients with Ann Arbor Stage I-II disease with progression/relapse after local therapy (including surgery, radiotherapy, etc.); Patients with newly diagnosed Ann Arbor Stage III-IV disease meeting the GELF criteria as recommended by the NCCN Guidelines;
Splenic marginal zone lymphoma (SMZL):
Patients with progression/relapse after local therapy (including splenectomy, antiviral therapy in HCV-positive patients, etc.); Or newly diagnosed with: progressive or painful splenomegaly, symptomatic or progressive cytopenia, defined as Hb < 100 g/L, PLT < 80 × 10⁹/L, or absolute neutrophil count (ANC) < 1.0 × 10⁹/L;
Nodal marginal zone lymphoma (NMZL):
Patients with Ann Arbor Stage I-II disease with progression/relapse after local therapy (including surgery, radiotherapy, etc.); Patients with newly diagnosed Ann Arbor Stage III-IV disease meeting the GELF criteria as recommended by the NCCN Guidelines;
Exclusion Criteria:
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Hospital
| Name | Role | Phone | Extension | |
|---|---|---|---|---|
| Keshu Zhou | Contact | 136 7490 2391 | dr_zkshu23810@163.com |
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The percentage of patients who remained alive at 2 years after study entry.
| 2 years |