NCT06134284 Clinical Study of OR for Second-line Treatment of Refractory MZL
| NCT ID | NCT06134284 |
| Status | Recruiting |
| Phase | Phase 4 |
| Sponsor | Lixia Sheng |
| Condition | OR Regimen for Relapsed/Refractory Marginal Zone Lymphoma |
| Study Type | INTERVENTIONAL |
| Enrollment | 39 participants |
| Start Date | 2023-01-02 |
| Primary Completion | 2026-12-31 |
Trial Parameters
Eligibility Fast-Check
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Brief Summary
The goal of this clinical trial is to test the overall response rate of Orelabrutinib combined with rituximab (OR regimen) for second-line treatment of relapsed/refractory marginal zone lymphoma.
Eligibility Criteria
Inclusion Criteria: 1. Age: 18 years, 80, Sex gender no limitied; 2. histological confirmation of MZL, For splenic marginal zone lymphoma (SMZL) where histological specimens of the spleen were not available, Requirements to meet the minimum diagnostic criteria for SMZL, And exclude any other type of small B cell lymphoma, That is, requiring a definite diagnosis of MZL; 3. at least one two-dimensional measurable lymph node lesion (CT scan or MR / display maximum diameter\> 1.5cm), Or at least one two-dimensional measurable extranodal lesion (CT scan or MRI showing maximum diameter\> 1.0cm); 4. the investigator required systemic treatment for marginal zone lymphoma; 5. at least 1 previous course of systemic lymphoma treatment (including previous immunotherapy or chemoimmunotherapy), 3 without efficacy above PR after imaging evaluation, Or disease progression after effective treatment; 6. ECOG, physical strength score 0-2; 7. primary organ function meets the following criteria 7 days prio