Orelabrutinib Combined With Rituximab ± Lenalidomide in Response-Adapted Stratified Therap
This is a prospective, single-arm, phase II study aimed at evaluating the safety and efficacy of orelabrutinib combined with rituximab ± lenalidomide in response-adapted stratified therapy for untreated marginal zone lymphoma. The primary endpoint is the complete response rate (CRR).
| Condition(s) | Marginal Zone Lymphoma(MZL) |
|---|---|
| Status | Recruiting |
| Phase | Phase 2 |
| Study type | Interventional |
| Summary | This is a prospective, single-arm, phase II study aimed at evaluating the safety and efficacy of orelabrutinib combined with rituximab ± lenalidomide in response-adapted stratified therapy for untreated marginal zone lymphoma. The primary endpoint is the complete response rate (CRR). |
| Who can participate | Inclusion Criteria: 1. Aged ≥18 years, either sex. 2. Histopathologically confirmed CD20-positive marginal zone lymphoma (including MALT, SMZL, and NMZL) with at least 1 measurable lesion. 3. Stage III or IV disease with an indication for treatment. 4. No prior systemic therapy. Patients may have received prior local treatment (including surgery, radiotherapy, anti-Helicobacter pylori therapy, or anti-hepatitis C therapy) if they subsequently progressed, relapsed, or were unsuitable for local therapy. 5. ECOG performance status of 0-2. 6. Adequate organ function meeting the following criteria: 1. Blood count: Absolute neutrophil count ≥1.5×10⁹/L, platelets ≥75×10⁹/L, hemoglobin ≥75 g/L. If bone marrow involvement is present: absolute neutrophil count ≥1.0×10⁹/L, platelets ≥50×10⁹/L, hemogl |
| Ages | 18 Years |
| Sex | All |
| Lead sponsor | The First Affiliated Hospital with Nanjing Medical University |
| Locations | Nanjing, Jiangsu, China |
| Start date | 2025-04-01 |
| NCT ID | NCT07448324 |
| Official listing | https://clinicaltrials.gov/study/NCT07448324 |