Marginal Zone Lymphoma
Conditions
Interventions
Experimental group:Orelabrutinib combined with anti-CD20 monoclonal antibody followed by Orelabrutinib maintenance
Sponsors
The Affiliated Hospital of Southwest Medical University
Eligibility
Sex/Gender
All
Age
18 Years to No maximum
Inclusion criteria
Inclusion criteria: Only subjects who meet all of the following inclusion criteria can be enrolled in this trial: 1. Age >=18 years old, gender not limited; 2. The CD20-positive marginal zone lymphomas confirmed by histopathology include MALT, SMZL and NMZL. At least one measurable lesion; 3. There are indications for treatment (for details, see the appendix); 4. Those who have not received systematic treatment may include MZL that has progressed, relapsed or is not suitable for local treatment after previous local treatment (local treatment includes surgical resection and radiotherapy). 5.ECOG physical strength score: 0-3; 6. The main organs meet the following standards: a) Blood routine: Absolute neutrophil count >=1.5×10^9/L, platelet count >=75×10^9/L, hemoglobin >=75g/L; If accompanied by bone marrow invasion, the absolute value of neutrophils is >=1.0×10^9/L, platelets >=50×10^9/L, and hemoglobin >=50g/L; b) Blood biochemistry: Total bilirubin =3 months; 8. Voluntarily sign a written informed consent form before the trial screening.
Exclusion criteria
Exclusion criteria: Patients with any of the following conditions will be excluded from this study: 1. Current or prior history of other malignancies, unless they have undergone curative treatment with evidence of no recurrence or metastasis within the past 5 years; 2. Lymphoma involving the central nervous system or undergoing high-grade transformation; 3. Uncontrolled or significant cardiovascular diseases, including: a) NYHA Class II or higher congestive heart failure, unstable angina, myocardial infarction within 6 months prior to the first administration of the study drug, or existing arrhythmias requiring treatment at screening with left ventricular ejection fraction (LVEF) 470ms in females or>450ms in males at screening; d) Symptomatic or drug-treated coronary artery disease; e) Uncontrolled hypertension (requiring three or more adequately tolerated antihypertensive medications (including diuretics) for over one month despite lifestyle modifications, or requiring four or more medications for effective blood pressure control). 4. Participants with active bleeding within the past 2 months, those currently taking anticoagulants, or those with confirmed bleeding tendencies as assessed by investigators; 5. History of deep vein thrombosis or pulmonary embolism within the past 6 months; 6. Clinical evidence of significant gastrointestinal abnormalities affecting drug intake, transport, or absorption (e.g., dysphagia, chronic diarrhea, intestinal obstruction), or complete gastrectomy; 7. History of organ transplantation or allogeneic bone marrow transplantation; 8. Major surgery performed within 6 weeks prior to screening or minor surgery within 2 weeks prior to screening. Major surgery refers to procedures under general anesthesia, excluding diagnostic endoscopic examinations. The insertion of vascular access devices is exempt from this exclusion criterion; 9. Active infections or uncontrolled HBV (HBsAg-positive and/or HBcAb-positive with positive HBV DNA titer), HCV Ab-positive, HIV/AIDS, or other severe infectious diseases; definitions of active infections should be provided; 10. Participants with current pulmonary fibrosis, interstitial pneumonia, pneumoconiosis, radiation pneumonitis, drug-induced pneumonia, or other conditions significantly impairing lung function; 11. Previous treatment with BTK/BCR pathway inhibitors (e.g., PI3K/Syk) or BCL-2 inhibitors; 12. Pregnant or breastfeeding women, and individuals of reproductive age unwilling to use contraception; 13. Those requiring long-term use of CYP3A inhibitors or strong inducers; 14. Other conditions deemed unsuitable by investigators for participation in this trial.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Progression-Free Survival Rate in 2 Years; | — |
Secondary
| Measure | Time frame |
|---|---|
| Objective response rate;Complete response rate;Overall survival;Progression-free survival;Safety; | — |
Countries
China
Contacts
Public ContactHongyun Xing
The Affiliated Hospital of Southwest Medical University
Outcome results
None listed