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OncoMatch/Clinical Trials/NCT06134284

Clinical Study of OR for Second-line Treatment of Refractory MZL

Is NCT06134284 recruiting? Yes, currently enrolling (May 2026). This Phase 4 trial studies Orelabrutinib combined with rituximab for or regimen for relapsed/refractory marginal zone lymphoma.

Phase 4RecruitingLixia ShengNCT06134284Data as of May 2026

Treatment: Orelabrutinib combined with rituximabThe 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.

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Extracted eligibility criteria

Cancer type

Non-Hodgkin Lymphoma

Performance status

ECOG 0–2(Ambulatory, capable of self-care)

Prior therapy

Min 1 prior line

Must have received: systemic lymphoma treatment

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

Cannot have received: obutinib in combination with rituximab (obutinib, rituximab)

previously treated with obutinib in combination with rituximab, Efficacy was assessed as being refractory, Infraciness was defined as no remission (PR or CR) after start of treatment

Cannot have received: BTK inhibitor

Previous treatment with BTK, BCR, pathway inhibitors (such as PI3K, Syk), and BCL-2 kinase inhibitors

Cannot have received: BCR pathway inhibitor

Previous treatment with BTK, BCR, pathway inhibitors (such as PI3K, Syk), and BCL-2 kinase inhibitors

Cannot have received: PI3K inhibitor

Previous treatment with BTK, BCR, pathway inhibitors (such as PI3K, Syk), and BCL-2 kinase inhibitors

Cannot have received: Syk inhibitor

Previous treatment with BTK, BCR, pathway inhibitors (such as PI3K, Syk), and BCL-2 kinase inhibitors

Cannot have received: BCL-2 kinase inhibitor

Previous treatment with BTK, BCR, pathway inhibitors (such as PI3K, Syk), and BCL-2 kinase inhibitors

Lab requirements

Blood counts

absolute neutrophil ≥1.5x10^9 / L, Platelet≥ 75x10^9 / L, Hemoglobin≥75g / L; If the concomitant bone marrow invasion, Absolute neutrophil value ≥1.0x10^9 / L, Platelet≥50x10^9 / L, Hemoglobin≥ 50g / L

Kidney function

Serum creatinine ≤ 1.5 times ULN or creatinine clearance ≥45 ml/min (Cockcroft-Gault formula); Serum amylase ≤ULN

Liver function

total bilirubin ≤1.5 times ULN, AST or ALT ≤2 times ULN; If the liver is infiltrated with a lymphoma, Then, ALT and AST ≤5 times ULN

Cardiac function

left ventricular ejection fraction 50%

primary organ function meets the following criteria 7 days prior to treatment: blood routine: absolute neutrophil ≥1.5x10^9 / L, Platelet≥ 75x10^9 / L, Hemoglobin≥75g / L; If the concomitant bone marrow invasion, Absolute neutrophil value ≥1.0x10^9 / L, Platelet≥50x10^9 / L, Hemoglobin≥ 50g / L; Blood Chemistry: total bilirubin ≤1.5 times ULN, AST or ALT ≤2 times ULN; If the liver is infiltrated with a lymphoma, Then, ALT and AST ≤5 times ULN, Serum creatinine ≤ 1.5 times ULN or creatinine clearance ≥45 ml/min (Cockcroft-Gault formula); Serum amylase ≤ULN; coagulation function: International normalized ratio (INR) ≤1.5 times ULN, Activated partial thromboplastin time (APTT)≤ 1.5 times ULN. cardiac color ultrasound: left ventricular ejection fraction 50%

Structured fields extracted by AI. May contain errors — verify against the official protocol.

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