Marginal Zone Lymphoma
Conditions
Interventions
Treatment group:bendamustine combined with zuberitamab followed by orelabrutinib combined with zuberitamab
Sponsors
The First Affiliated Hospital of the Air Force Medical University
Eligibility
Sex/Gender
All
Age
18 Years to No maximum
Inclusion criteria
Inclusion criteria: Patients must meet all of the following inclusion criteria to 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 systemic treatment may include those who have progressed, relapsed or are not suitable for local treatment after previous local treatment; 5.ECOG Stamina score: 0-2; 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 are not eligible for this study: 1. Currently or previously suffering from other malignant tumors, unless radical treatment has been received and there is evidence of no recurrence or metastasis in the past five years; 2. Lymphoma involves the central nervous system or progresses to a higher grade; 3. Have uncontrollable or significant cardiovascular diseases, including: a) Within 6 months prior to the first administration of the study drug, New York Heart Association (NYHA) grade II or above congestive heart failure, unstable angina pectoris, myocardial infarction occurred, or there was an arrhythmia requiring treatment at the time of screening, with a left ventricular ejection fraction (LVEF) 470ms in females and >450ms in males during the screening period; d) Subjects with symptomatic or drug-requiring coronary heart disease; e) Suffering from uncontrollable hypertension (blood pressure has not reached the target after taking reasonable and tolerable doses of three or more antihypertensive drugs (including diuretics) for more than one month on the basis of improving lifestyle, or blood pressure can only be effectively controlled after taking four or more antihypertensive drugs). 4. There was active bleeding within two months before screening, or the patient was taking anticoagulant drugs, or the researcher believed there was a clear bleeding tendency; 5. There is a history of deep vein thrombosis or pulmonary embolism within the past six months; 6. Subjects with clinically obvious gastrointestinal abnormalities that may affect drug intake, transport or absorption (such as inability to swallow, chronic diarrhea, intestinal obstruction, etc.), or those who have undergone total gastrectomy; 7. Have a history of organ transplantation or allogeneic bone marrow transplantation; 8. Major surgery was performed within 6 weeks before screening or minor surgery was performed within 2 weeks before screening. Major surgery refers to surgeries performed under general anesthesia, but endoscopy for diagnostic purposes is not considered major surgery. The insertion of vascular access devices will be exempted from this exclusion criterion; 9. Active infection or uncontrolled HBV(HBsAg positive and/or HBcAb positive with positive HBV DNA titer), HCV Ab positive, HIV/AIDS or other severe infectious diseases; 10. Currently, there are subjects whose lung function is severely affected by conditions such as pulmonary fibrosis, interstitial pneumonia, pneumoconiosis, radiation pneumonitis, and drug-related pneumonia; 11. Previously treated with BTK, BCR pathway inhibitors (such as PI3K, Syk), and BCL-2 inhibitors; 12. Pregnant and lactating women and subjects of childbearing age who are unwilling to take contraceptive measures; 13. It is necessary to continuously take drugs with moderate to severe inhibitory or strong inducing effects on cytochrome P450 CYP3A. 14. Other circumstances that the researcher deems unsuitable for participation in this trial
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Objective response rate; | — |
Secondary
| Measure | Time frame |
|---|---|
| Complete Response Rate;Duration of Response;Progression-free survival;Overall survival;Safety; | — |
Countries
China
Contacts
Public ContactGuangxun Gao
The First Affiliated Hospital of the Air Force Medical University
Outcome results
None listed