OncoMatch/Clinical Trials/NCT06504940
Optimize Study - Orelabrutinib Combined With BR/G in Untreated Marginal Zone Lymphoma (MZL)
Is NCT06504940 recruiting? Yes, currently enrolling (May 2026). This Phase 2 trial studies multiple treatments including Orelabrutinib combined with bendamustine and rituximab and Orelabrutinib combined with obinutuzumab for marginal zone lymphoma.
Treatment: Orelabrutinib combined with bendamustine and rituximab · Orelabrutinib combined with obinutuzumab — This is a multi-center, prospective cohort study. The main purpose of Cohort A is to evaluate the efficacy and safety of Orelabrutinib combined with BR (bendamustine and rituximab) for previously untreated young patients with MZL; the purpose of Cohort B is to assess the efficacy and safety of Orelabrutinib combined with G (Obinutuzumab) followed by Orelabrutinib maintenance therapy for previously untreated elderly patients with MZL.
Check if I qualifyExtracted eligibility criteria
Cancer type
Non-Hodgkin Lymphoma
Performance status
ECOG 0–3(Limited self-care)
Prior therapy
Must have received: local treatment (surgery, radiotherapy, Helicobacter pylori treatment, hepatitis C treatment)
Progression, recurrence after local treatment, or unsuitable for local treatment (local treatments include surgery, radiotherapy, Helicobacter pylori treatment, hepatitis C treatment).
Cannot have received: BTK inhibitor
Previously treated with BTK...inhibitors
Cannot have received: BCR pathway inhibitor (PI3K, Syk)
Previously treated with...BCR pathway inhibitors (such as PI3K, Syk)
Cannot have received: BCL-2 inhibitor
Previously treated with...BCL-2 inhibitors
Lab requirements
Blood counts
Absolute neutrophil count ≥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 ≤1.5x ULN
Liver function
Total bilirubin ≤1.5x ULN, AST or ALT ≤2x ULN; serum creatinine ≤1.5x ULN; serum amylase ≤ULN.
Cardiac function
INR ≤1.5x ULN; no NYHA class II or above CHF, unstable angina, MI, or arrhythmias requiring treatment within 6 months; LVEF <50% excluded; no primary cardiomyopathy; no significant QTc prolongation (>470ms females, >450ms males); no symptomatic or medication-requiring coronary artery disease; no uncontrollable hypertension.
Major organ functions meet the following criteria: a) Complete blood count... b) Blood biochemistry... c) Coagulation function: INR ≤1.5x ULN. Exclusion: significant cardiovascular diseases as detailed.
Structured fields extracted by AI. May contain errors — verify against the official protocol.
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