OncoMatch/Clinical Trials/NCT07022223
Orelabrutinib Combined With Rituximab as First-line Systemic Treatment for Marginal Zone Lymphoma
Is NCT07022223 recruiting? Yes, currently enrolling (May 2026). This Phase 2 trial studies orelabrutinib combined with rituximab regimen for marginal zone lymphoma(mzl).
Treatment: orelabrutinib combined with rituximab regimen — This is a single-arm, prospective clinical study to evaluate the efficacy and safety of orelabrutinib combined with rituximab as first-line systemic treatment for marginal zone lymphoma.
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
Performance status
ECOG 0–2(Ambulatory, capable of self-care)
Prior therapy
Must have received: local therapy (surgery, radiotherapy, anti-Helicobacter pylori treatment, anti-hepatitis C treatment)
MZL that has progressed or relapsed after prior local therapy (including surgery, radiotherapy, anti-Helicobacter pylori treatment, and anti-hepatitis C treatment), or is not suitable for local therapy
Cannot have received: BTK inhibitor
Previous treatment with BTK...inhibitors
Cannot have received: BCR pathway inhibitor (PI3K, Syk)
Previous treatment with...BCR pathway inhibitors (such as PI3K, Syk)
Cannot have received: BCL-2 inhibitor
Previous treatment with...BCL-2 inhibitors
Lab requirements
Blood counts
Absolute neutrophil count ≥ 1.5×10^9/L, platelets ≥ 75×10^9/L, hemoglobin ≥ 75 g/L; if bone marrow involvement, ANC ≥ 1.0×10^9/L, platelets ≥ 50×10^9/L, hemoglobin ≥ 50 g/L
Kidney function
serum creatinine ≤ 1.5 times ULN; urine protein ≥ 2+, and 24-hour urine protein quantification ≥ 2 g/24 hours [excluded]
Liver function
Total bilirubin ≤ 1.5 times ULN, AST or ALT ≤ 2 times ULN
Cardiac function
NYHA Class II or higher congestive heart failure, unstable angina, MI within 6 months, arrhythmias requiring treatment, LVEF < 50%, primary cardiomyopathy, QTc > 470 ms (female), > 450 ms (male), symptomatic or medically treated coronary artery disease, uncontrolled hypertension [all excluded]
Adequate function of major organs, as follows: Hematology: Absolute neutrophil count ≥ 1.5×10^9/L, platelets ≥ 75×10^9/L, hemoglobin ≥ 75 g/L; if there is bone marrow involvement, absolute neutrophil count ≥ 1.0×10^9/L, platelets ≥ 50×10^9/L, hemoglobin ≥ 50 g/L; Biochemistry: Total bilirubin ≤ 1.5 times ULN, AST or ALT ≤ 2 times ULN; serum creatinine ≤ 1.5 times ULN; serum amylase ≤ ULN; Coagulation: INR ≤ 1.5 times ULN.
Structured fields extracted by AI. May contain errors — verify against the official protocol.
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