OncoMatch/Clinical Trials/NCT07448324
Orelabrutinib Combined With Rituximab ± Lenalidomide in Response-Adapted Stratified Therapy for Untreated MZL
Is NCT07448324 recruiting? Yes, currently enrolling (May 2026). This Phase 2 trial studies multiple treatments including Orelabrutinib and Rituximab for marginal zone lymphoma(mzl).
Treatment: Orelabrutinib · Rituximab · Lenalidomide — This is a prospective, single-arm, phase II study aimed at evaluating the safety and efficacy of orelabrutinib combined with rituximab ± lenalidomide in response-adapted stratified therapy for untreated marginal zone lymphoma. The primary endpoint is the complete response rate (CRR).
Check if I qualifyExtracted eligibility criteria
Cancer type
Non-Hodgkin Lymphoma
Biomarker criteria
Required: MS4A1 overexpression (CD20-positive)
CD20-positive marginal zone lymphoma
Disease stage
Required: Stage III, IV
Performance status
ECOG 0–2(Ambulatory, capable of self-care)
Prior therapy
Cannot have received: BTK inhibitor
Prior treatment with BTK inhibitors
Cannot have received: BCR pathway inhibitor (PI3K inhibitor, Syk inhibitor)
Prior treatment with BCR pathway inhibitors (e.g., PI3K, Syk inhibitors)
Cannot have received: BCL-2 inhibitor
Prior treatment with BCL-2 inhibitors
Lab requirements
Blood counts
Absolute neutrophil count ≥1.5×10⁹/L, platelets ≥75×10⁹/L, hemoglobin ≥75 g/L. If bone marrow involvement: ANC ≥1.0×10⁹/L, platelets ≥50×10⁹/L, hemoglobin ≥50 g/L.
Kidney function
serum creatinine ≤1.5×ULN
Liver function
Total bilirubin ≤1.5×ULN, AST or ALT ≤2×ULN
Cardiac function
No NYHA Class II or higher CHF, unstable angina, MI within 6 months, arrhythmia requiring treatment, LVEF <50%, primary cardiomyopathy, QTc >470 ms (female) or >450 ms (male), symptomatic CAD, poorly controlled hypertension
Adequate organ function meeting the following criteria: ... Blood count: Absolute neutrophil count ≥1.5×10⁹/L, platelets ≥75×10⁹/L, hemoglobin ≥75 g/L. If bone marrow involvement is present: absolute neutrophil count ≥1.0×10⁹/L, platelets ≥50×10⁹/L, hemoglobin ≥50 g/L. Blood chemistry: Total bilirubin ≤1.5×ULN, AST or ALT ≤2×ULN; serum creatinine ≤1.5×ULN; serum amylase ≤ULN. Coagulation: INR ≤1.5×ULN. ... Uncontrolled or significant cardiovascular diseases, including: NYHA Class II or higher CHF, unstable angina, MI within 6 months, arrhythmia requiring treatment, LVEF <50%, primary cardiomyopathy, QTc >470 ms (female) or >450 ms (male), symptomatic CAD, poorly controlled hypertension
Structured fields extracted by AI. May contain errors — verify against the official protocol.
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