OncoMatch/Clinical Trials/NCT07022223
Orelabrutinib Combined With Rituximab as First-line Systemic Treatment for Marginal Zone Lymphoma
Is NCT07022223 recruiting? Yes, currently enrolling (Jun 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
Treatments studied
Immunotherapy
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.
Frequently asked questions
Is NCT07022223 currently recruiting?
Yes, this trial is currently recruiting patients.
Are there prior therapy exclusions?
Yes. Prior BTK inhibitor, BCR pathway inhibitor, BCL-2 inhibitor disqualifies patients from enrollment.
Does this trial require MS4A1?
Yes, MS4A1 overexpression is a required biomarker for enrollment.
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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