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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).

Phase 2RecruitingThe First Affiliated Hospital of Soochow UniversityNCT07372365Data as of May 2026

Treatment: Orelabrutinib Consolidation and Maintenance TherapyThis 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.

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Extracted 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

No prior treatment (treatment-naive required)
Max 0 prior lines
Min 0 prior lines

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.

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