OncoMatch/Clinical Trials/NCT07372365
Orelabrutinib as Consolidation and Maintenance Therapy in Treatment-Naïve MZL.
Is NCT07372365 recruiting? Yes, currently enrolling (May 2026). This Phase 2 trial studies Orelabrutinib Consolidation and Maintenance Therapy for marginal zone lymphoma (mzl).
Treatment: Orelabrutinib Consolidation and Maintenance Therapy — This study aims to explore a new treatment approach for patients with treatment-naive Marginal Zone Lymphoma (MZL). MZL is a type of slow-growing lymphoma that often affects older adults. The current standard treatment involves chemotherapy, but it can have significant side effects and may not always provide long-term benefits. This study investigates a treatment strategy that combines a limited course of chemotherapy (R-CHOP) followed by consolidation and maintenance therapy with a targeted drug called Orelabrutinib. Patients will undergo a series of tests to determine eligibility for the study. These tests include blood work, imaging studies, and assessments of overall health. Eligible participants will receive a standard chemotherapy regimen called R-CHOP for three cycles. After this, the response to treatment will be evaluated. Participants who show a good response will then receive three cycles of consolidation therapy with Orelabrutinib and Rituximab (OR). Those who continue to respond well will enter a maintenance phase with Orelabrutinib for up to two years. Throughout the study, participants will be closely monitored for treatment response and any side effects. Regular check-ups, blood tests, and imaging studies will be conducted to assess the effectiveness and safety of the treatment. This study is an important step towards finding better treatment options for MZL patients. It is hoped that through this research, the quality of life and outcomes for those affected by this disease can be improved.
Check if I qualifyExtracted eligibility criteria
Cancer type
Non-Hodgkin Lymphoma
Biomarker criteria
Required: MS4A1 overexpression (CD20-positive)
Histologically confirmed CD20-positive marginal zone lymphoma (MZL)
Performance status
ECOG 0–2(Ambulatory, capable of self-care)
Prior therapy
Lab requirements
Blood counts
hemoglobin (hb) ≥60 g/l, platelets (plt) ≥50×10⁹/l, neutrophils (ne) ≥1.0×10⁹/l (note: subjects with cytopenia due to lymphoma bone marrow involvement are not restricted by this criterion)
Kidney function
creatinine ≤1.5×uln or creatinine clearance ≥30 ml/min
Liver function
ast and alt ≤3×uln
Cardiac function
left ventricular ejection fraction (lvef) ≥50% as determined by echocardiogram
Structured fields extracted by AI. May contain errors — verify against the official protocol.
Could you qualify for this trial?
Enter your biomarker results to see how this trial's eligibility criteria match your specific cancer profile.
Check if I qualify