marginal zone lymphoma,MZL
Conditions
Interventions
Single arm:Obutinib Rituximab Lenalidomide
Sponsors
Army Characteristic Medical Center, Department of Hematology
Eligibility
Sex/Gender
All
Age
18 Years to 80 Years
Inclusion criteria
Inclusion criteria: 1. Age = 18 years old, gender not limited; 2. The pathological diagnosis of the research center's tissue is borderline lymphoma; 3. Serum protein electrophoresis revealed positive results for M protein or immunofixation electrophoresis; 4. Expected survival time>3 months; 5. 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; 6. Biochemical tests must meet the following standards: TBIL<2.0 × ULN, ALT and AST<2.5 × ULN; 7. The patient voluntarily participates in this study, fully understands and is aware of this study, and signs an informed consent form.
Exclusion criteria
Exclusion criteria: 1. Patients who have progressed in efficacy when receiving other BTK inhibitors in the past; 2. Uncontrolled, active systemic fungal, bacterial, viral, or other infections (defined as persistent signs/symptoms associated with the infection that do not improve despite appropriate antibiotics or other treatments); Cancer related B symptoms except for fever. 3. Allergic constitution or hypersensitivity reaction to any other component of Obutinib, Rituximab or other applicable research drugs; 4. There are uncontrollable or significant cardiovascular diseases, including: a) Within 6 months prior to the initial administration of the investigational drug, the patient has developed NYHA grade II or higher congestive heart failure, unstable angina, myocardial infarction, or an arrhythmia requiring treatment during 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-induced coronary heart disease; e) Suffering from uncontrollable hypertension (on the basis of improving lifestyle, using a reasonable and tolerable amount of 2 or more antihypertensive drugs (including diuretics) for more than 1 month without reaching blood pressure standards, or taking 4 or more antihypertensive drugs to effectively control blood pressure); 5. Abnormal coagulation function (INR>1.5 or prothrombin time (PT)>ULN+4 seconds or APTT>1.5 ULN), or active bleeding within the past 2 months prior to screening, or taking anticoagulant drugs, or the researcher believes there is a clear bleeding tendency; 6. Active or uncontrolled HBV (HBsAg positive and HBV DNA titer positive), HCV Ab positive or HIV positive; 7. Poor compliance or inability to follow up regularly; 8. There are patients who may pose a threat to life or have severe organ dysfunction, and the researchers have determined that they are not suitable to participate in this trial; 9. According to the researchers' judgment, there are significant organ dysfunction or uncontrollable comorbidities that pose safety risks after medication, as well as metabolic disorders related to the absorption of Obutinib tablets.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Overall Response Rate, ORR; | — |
Secondary
| Measure | Time frame |
|---|---|
| Complete Remission, CR;Partial Remission, PR;Progression-free survival, PFS;overall survival OS; | — |
Countries
China
Contacts
Public Contactzengdongfeng
Army Characteristic Medical Center, Department of Hematology
Outcome results
None listed