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OncoMatch/Clinical Trials/NCT07441993

Exploratory Study of Orelabrutinib in the Treatment of Early-stage Untreated MZL

Is NCT07441993 recruiting? Yes, currently enrolling (May 2026). This Phase 2 trial studies Orelabrutinib for marginal zone lymphoma.

Phase 2RecruitingInstitute of Hematology & Blood Diseases Hospital, ChinaNCT07441993Data as of May 2026

Treatment: OrelabrutinibThis is a single-arm, multicenter, prospective, phase II study. The primary objective is to assess the efficacy and safety of orelabrutinib in treatment-naïve patients with marginal zone lymphoma.

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Extracted eligibility criteria

Cancer type

Non-Hodgkin Lymphoma

Disease stage

Required: Stage I, II

Performance status

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

Prior therapy

No prior treatment (treatment-naive required)

Lab requirements

Blood counts

ANC ≥1.5×10^9/L, platelets ≥75×10^9/L, hemoglobin ≥75g/L; if bone marrow involvement: ANC ≥1.0×10^9/L, platelets ≥50×10^9/L, hemoglobin ≥50g/L

Kidney function

serum creatinine ≤1.5×ULN

Liver function

Total bilirubin ≤1.5×ULN, AST or ALT ≤2×ULN

Cardiac function

NYHA Class II or higher congestive heart failure, unstable angina, MI within 6 months, arrhythmia requiring treatment, LVEF <50%, primary cardiomyopathy, QTc >470 ms (female) or >450 ms (male), symptomatic coronary artery disease requiring medication, poorly controlled hypertension

Blood tests: ANC ≥1.5×10^9/L, platelets ≥75×10^9/L, hemoglobin ≥75g/L; if accompanied by bone marrow involvement, ANC ≥1.0×10^9/L, platelets ≥50×10^9/L, hemoglobin ≥50g/L; Blood biochemistry: Total bilirubin ≤1.5×ULN, AST or ALT ≤2×ULN; serum creatinine ≤1.5×ULN; NYHA Class II or higher congestive heart failure, unstable angina, MI within 6 months, arrhythmia requiring treatment, LVEF <50%, primary cardiomyopathy, QTc >470 ms (female) or >450 ms (male), symptomatic coronary artery disease requiring medication, poorly controlled hypertension

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

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