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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 (Jun 2026). This Phase 2 trial studies Orelabrutinib for marginal zone lymphoma.

Phase 2RecruitingInstitute of Hematology & Blood Diseases Hospital, ChinaNCT07441993Data as of Jun 2026Location: China

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

Treatments studied

Targeted therapy

Orelabrutinib

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.

Frequently asked questions

Is NCT07441993 currently recruiting?

Yes, this trial is currently recruiting patients.

Can patients have received prior systemic therapy?

No. This trial requires treatment-naive patients — prior systemic therapy is an exclusion criterion.

What disease stage is eligible?

Stage I or II is required.

Could you qualify for this trial?

Enter your biomarker results to see how this trial's eligibility criteria match your specific cancer profile.

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