Extranodal marginal zone lymphoma
Conditions
Interventions
Lymphoma of extranodal margin of ocular adnexal mucosa associated lymphoid tissue:Local radiation therapy (target delineation recommended):
GTVp (Primary Tumor Region) Definition Criteria: The approxi
Total dose 4Gy (over 2 days)
Specific medication regimens:
orelabrutinib: 150 mg orally daily 2 weeks after end of radiation therapy for 1 year, adjust as tolerated by patient (1 cycle every 30 days)
During the treatment period, re-imaging was performed every 3 months to assess the efficacy of CR/PR/SD, and the patient was continued to be enrolled for a total of 1 year. If PD is decommissioned.
Sponsors
Army Medical Center of PLA
Eligibility
Sex/Gender
All
Age
18 Years to No maximum
Inclusion criteria
Inclusion criteria: 1.Age >=18 years old, gender not limited; 2.Pathological diagnosis of extranodal marginal zone lymphoma of ocular adnexal mucosa associated lymphoid tissue in the research center; 3.Ann Arbor clinical stages I-II; 4.The standard for blood routine examination should meet the following criteria: absolute neutrophil count (ANC) >= 1.0 ×10^9/L, platelet count (PLT) >=30 ×10^9/L; Unless it is confirmed that the bone marrow and hematopoietic dysfunction is caused by lymphoma; 5.Biochemical tests must meet the following standards: TBIL<2.0 × ULN, ALT and AST<2.5 × ULN; 6.The patient voluntarily participated in this study, fully understood and informed of the study, and signed an informed consent form.
Exclusion criteria
Exclusion criteria: (1) Patients whose efficacy has progressed when receiving other BTK inhibitors in the past; (2) uncontrolled, active systemic fungal, bacterial, viral, or other infection (defined as exhibiting ongoing signs/symptoms associated with the infection that do not improve despite the use of appropriate antibiotics or other treatments); Exceptions are fever for tumor-related B symptoms. (3) Allergic constitution or hypersensitivity reaction to orelabrutinib or any other component of other applicable study drugs; (4) Have uncontrolled or significant cardiovascular diseases, including: a) New York Heart Association (NYHA) grade II or higher congestive heart failure, unstable angina, myocardial infarction, or arrhythmia requiring treatment at screening with left ventricular ejection fraction (LVEF) 470 ms for women and > for men during the screening period450ms; d) Subjects with coronary heart disease who are symptomatic or require medication; e) Suffering from uncontrollable hypertension (on the basis of lifestyle modification, the blood pressure has not reached the target for more than 1 month after using a reasonable and tolerated sufficient amount of 2 or more antihypertensive drugs (including diuretics), or the blood pressure can only be effectively controlled by taking 4 or more antihypertensive drugs); (5) Coagulation dysfunction (INR>1.5 or prothrombin time (PT) >ULN+4 seconds or APTT >1.5 ULN) or active bleeding within 2 months prior to screening, or taking anticoagulant drugs, or definite bleeding tendency in the opinion of the investigator; (6) HIV positive; (7) Those with poor compliance or inability to follow up regularly; (8) Patients with potentially life-threatening diseases, or severe organ dysfunction, judged by the investigator to be unsuitable for participating in this trial; (9) As judged by the investigator, there is a major organ dysfunction or an uncontrollable comorbid disease, there will be a safety risk after medication, and there is a disorder of absorption and metabolism of orelabrutinib tablets.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Complete Remission, CR;Overall Response Rate, ORR;Progression-free survival, PFS; | — |
Secondary
| Measure | Time frame |
|---|---|
| Partial Remission, PR;Overall survival OS;Adverse event;Quality of Life Assessment; | — |
Countries
China
Contacts
Public ContactDongfeng Zeng
Army Medical Center of PLA
Outcome results
None listed