Marginal Zone Lymphoma
Conditions
Interventions
Treatment group:Consolidation and maintenance treatment regimens that include orelabrutinib.
Sponsors
The First Affiliated Hospital of Soochow University
Eligibility
Sex/Gender
All
Age
18 Years to No maximum
Inclusion criteria
Inclusion criteria: 1. Histologically confirmed CD20-positive marginal zone lymphoma (MZL) that has not received prior systemic therapy; 2. MZL that has progressed or relapsed after prior local therapy (including surgery, radiotherapy, Helicobacter pylori eradication, and hepatitis C treatment), or is not amenable to local therapy; 3. Age >=18 years; 4. Presence of an indication for treatment as judged by the investigator or patient willingness to undergo treatment; 5. Eastern Cooperative Oncology Group (ECOG) performance status score =60 g/L, platelets (PLT) >=50×10^9/L, neutrophils (NE) >=1.0×10^9/L (Note: Patients with cytopenias due to lymphoma bone marrow involvement are not restricted by these criteria); • Echocardiographic left ventricular ejection fraction >=50%; • Creatinine =30 ml/min; • Alanine aminotransferase (ALT) and aspartate aminotransferase (AST) <=3 times the upper limit of normal; 7. Women of childbearing potential must have a negative pregnancy test; both male and female patients must agree to use effective contraception during the treatment period and for 2 years thereafter; 8. Life expectancy of more than 3 months; 9. Voluntary provision of informed consent.
Exclusion criteria
Exclusion criteria: 1. Underwent major surgery or severe trauma within 2 weeks prior to enrollment, or has not yet recovered from significant adverse effects; 2. Has a current malignancy or has had another malignancy within the past 3 years, with the exception of adequately treated basal or squamous cell carcinoma of the skin, superficial bladder cancer, prostatic intraepithelial neoplasia, and cervical carcinoma in situ; 3. Has a history of stroke or intracranial hemorrhage within the past 3 months; 4. Requires anticoagulation with warfarin or equivalent vitamin K antagonist; 5. Has evidence of comorbidities or medical conditions that may interfere with the conduct of the study or place the patient at significant risk, including but not limited to severe cardiovascular disease (e.g., New York Heart Association Class III or IV heart disease, myocardial infarction within the past 6 months, unstable arrhythmias, or unstable angina) and/or severe pulmonary disease (e.g., severe obstructive pulmonary disease and a history of symptomatic bronchospasm); 6. Has human immunodeficiency virus infection, or has uncontrollable active hepatitis C virus or hepatitis B virus infection; 7. Has uncontrollable active infection; 8. Is pregnant or breastfeeding; 9. Has any life-threatening disease, medical condition, or organ system dysfunction that may jeopardize the safety of the patient, as determined by the investigator; 10. Has any condition that may interfere with the absorption or metabolism of orelabrutinib or place the study results at unnecessary risk; 11. Has central nervous system involvement by marginal zone lymphoma or evidence of disease transformation; 12. Has any condition that the investigator deems would interfere with full participation in the study, pose significant risk to the subject, or interfere with the interpretation of study data.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Complete remission (CR) rate; | — |
Secondary
| Measure | Time frame |
|---|---|
| Objective remission rate;Overall survival;Progression-free survival;Adverse events; | — |
Countries
China
Contacts
Public ContactTing Xu
The First Affiliated Hospital of Soochow University
Outcome results
None listed