NCT06566807 Oxygen Study-Orelabrutinib Combined With Obinutuzumab(O2) for First-Line Treatment of Marginal Zone Lymphoma

Eligibility & Interventions

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What to Expect as a Participant

You will actively receive the study intervention — which may be a drug, biologic, device, or procedure.

In Phase 2, researchers evaluate early signs of effectiveness. You may be randomized to receive the active treatment or a comparator. Monitoring continues closely.

This trial targets 51 participants in total. It began in 2024-08-25 with a primary completion date of 2026-08-10.

Brief Summary

This is a multi-center, prospective study. The main purpose is to evaluate the efficacy and safety of Orelabrutinib combined with Obinutuzumab for previously untreated MZL.

Eligibility Criteria

Inclusion Criteria: * Aged ≥18 years, gender not limited; * Histopathologically confirmed CD20-positive marginal zone lymphoma including MALT, SMZL, NMZL; * MZL that has progressed, recurred, or is not suitable for local treatment after previous local treatment (local treatments include surgery, radiotherapy, Helicobacter pylori treatment, and hepatitis C treatment); * ECOG 0-2; * Indication for treatment as judged by the investigator (symptomatic, with cytopenia, at risk of end-organ damage, bulky disease, persistent progression, or patient\'s desire for treatment); * Major organ function meets the following criteria: a) Complete blood count: Absolute neutrophil count ≥1.5×10\^9/L, platelets ≥75×10\^9/L, hemoglobin ≥75g/L; if accompanied by bone marrow invasion, absolute neutrophil count ≥1.0×10\^9/L, platelets ≥50×10\^9/L, hemoglobin ≥50g/L; b) Blood biochemistry: Total bilirubin ≤1.5 ULN, AST or ALT ≤2 ULN; serum creatinine ≤1.5 ULN; serum amylase ≤ULN; c) Coagulation function: International normalized ratio (INR) ≤1.5 ULN. * Expected survival time ≥3 months; * Voluntarily sign a written informed consent form before the trial screening. Exclusion Criteria: * Currently or previously diagnosed with other malignant tumors, unless curative treatment has been performed and there is evidence of no recurrence or metastasis within the last 5 years; * Lymphoma involving the central nervous system or transformation to a higher grade; * Active bleeding within 2 months prior to screening, or currently taking anticoagulant medications, or the investigator considers there to be a definite bleeding tendency; * Major surgery within 6 weeks prior to screening or minor surgery within 2 weeks prior to screening; * Active infection or uncontrolled HBV (positive for HBsAg and/or HBcAb and positive for HBV DNA titer), HCV Ab positive, HIV/AIDS, or other serious infectious diseases; * Any mental or cognitive disorder that may limit the understanding, execution, and compliance with the informed consent form and the study; * Pregnant or lactating women and women of childbearing age who are unwilling to take contraceptive measures; * Need to continuously take drugs with moderate to severe inhibitory or strong inductive effects on cytochrome P450 CYP3A; * Other conditions that the investigator considers unsuitable for participating in this trial.

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