OncoMatch/Clinical Trials/NCT06504940
Optimize Study - Orelabrutinib Combined With BR/G in Untreated Marginal Zone Lymphoma (MZL)
Is NCT06504940 recruiting? Yes, currently enrolling (Jun 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
Treatments studied
Immunotherapy
Other
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.
Frequently asked questions
Is NCT06504940 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.
Could you qualify for this trial?
Enter your biomarker results to see how this trial's eligibility criteria match your specific cancer profile.
Check if I qualifyRelated pages