OncoMatch/Clinical Trials/NCT07448324
Orelabrutinib Combined With Rituximab ± Lenalidomide in Response-Adapted Stratified Therapy for Untreated MZL
Is NCT07448324 recruiting? Yes, currently enrolling (Jun 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
Treatments studied
Immunotherapy
Targeted therapy
Endocrine / hormonal
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.
Frequently asked questions
Is NCT07448324 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.
Does this trial require MS4A1?
Yes, MS4A1 overexpression is a required biomarker for enrollment.
What disease stage is eligible?
Stage III or IV 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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