Primary central system B-cell lymphoma
Conditions
Interventions
Experimental group:Intravenous Rituximab and methotrexate plus Lenalidomide 25mg, qd, po, d1-10
Control group:Intravenous Rituximab and methotrexate
Sponsors
West China Hospital, Sichuan University
Eligibility
Sex/Gender
All
Inclusion criteria
Inclusion criteria: 1. Aged = 18 years old; 2. Meet the 2016 revision of the World Health Organization(WHO) classification of lymphoid neoplasms, histopathologically confirmed B-cell lymphoma with CD20(+); 3. Lesions are limited central nervous system (Containing brain parenchyma, eyes, spinal cord, pia mater); 4. Patients did not receive radiotherapy, chemotherapy or targeted therapy for lymphoma; 5. ECOG 0-3?; 6. The main organ function meets the following criteria within 7 days prior to treatment: (1) Blood routine examination criteria (without blood transfusion within 14 days): Hemoglobin (HB) = 80g/L; The absolute value of neutrophils (ANC) = 1.5 × 10^9/L; platelets (PLT) = 75 × 10^9/L; (2) Biochemical tests are subject to the following criteria: Total bilirubin (TBIL) = 1.5 times the upper limit of normal (ULN); Alanine aminotransferase (ALT) and aspartate aminotransferase AST=2.5ULN, or ALT and AST = 5ULN if liver involvement; Serum creatinine < 1.5 × Upper limit of normal reference value (ULN) or estimate Creatinine clearance rate = 60mL/min (meet the calculation standard of field survey center); 7. Men and women of childbearing age agreed to adopt reliable contraceptive methods during the entire study period and within 4 weeks after the end of study treatment; 8. Patients volunteered to participate in the study and signed informed consent.
Exclusion criteria
Exclusion criteria: 1. Lymphoma involving other organs and tissues except the central nervous system at diagnosis 2. Known to have human immunodeficiency virus(HIV); 3. Received solid organ transplantation or allogeneic hematopoietic stem cell transplantation; 4. In addition to the target tumors, the patient has suffered from or has suffered from an active malignant tumor in the past five years; 5. The patients were treated with other research drugs within 4 weeks before admission; 6. The patient is pregnant or lactating (any woman who is pregnant during the study will withdraw from the study immediately); 7. The patient has a serious infection, a clinically significant disease, or a mental illness. The investigator believes that the condition may interfere with the achievement of the research purpose; 8. Clinically significant cardiovascular abnormalities (New York Heart Association (NYHA) classification: III/IV), myocardial infarction within 6 months prior to enrollment, malignant arrhythmia (including QTC = 480ms), blood pressure unsatisfactory control when using antihypertensive drugs(systolic blood pressure =150 mmHg, diastolic blood pressure =100 mmHg), uncontrolled angina; 9. Patients with a history of psychotropic substance abuse who is unable to quit or has a mental disorder; 10. Those who are severely allergic to the active ingredients of this product or any of its excipients; 11. According to the investigator's judgment, there are patients with severe disease that are harmful to the safety of the patient or affect the patient's completion of the study.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Progression free survival(PFS); | — |
Secondary
| Measure | Time frame |
|---|---|
| event-free survival (EFS);Safety;overall survival(OS); | — |
Countries
China
Contacts
Public ContactJiang Ming
West China Hospital, Sichuan University
Outcome results
None listed