B cell lymphoma
Conditions
Interventions
experimental group:zebutinib, rituximab, methotrexate and lenalidomide
Sponsors
The Affiliated Hospital of Xuzhou Medical University
Eligibility
Sex/Gender
All
Inclusion criteria
Inclusion criteria: 1. Patients who meet the diagnostic criteria for relapsed or refractory primary central nervous system B-cell lymphoma: previously treated with at least 2 chemotherapy regimens; the interval between the last chemotherapy and disease progression is less than 1 year; not suitable for hematopoietic stem cell transplantation or due to limitations Abandon hematopoietic stem cell transplantation. 2. Aged 12 to 75 years; 3. The expected survival period is 6 months to 2 years; 4. Using the Eastern Cooperative Oncology Group (ECOG) scale score =1.0x10^9/L; platelet count (PLT) >=50x10^9/L; hemoglobin concentration >=7.0 g/dL; (2) Liver function: aspartate aminotransferase (AST) and alanine aminotransferase (ALT) = 50 mL/min (standard Cockcroft-Gault formula, see Annex 4); (4) Coagulation function: international normalized ratio (INR) <= 1.5xULN; activated partial thromboplastin time (APTT) <= upper limit of normal 10s; e) thyroid-stimulating hormone (TSH) within the normal range; if TSH is abnormal, free Triiodothyronine (FT3), free thyroxine (FT4) must be within the normal range, and thyroid peroxidase antibody (TPOAb), thyroglobulin antibody (TgAb), thyroid stimulating hormone receptor antibody (TRAb) ) are all negative; 6. Women of childbearing age have a negative urine pregnancy test before the start of administration. During the study period and within 6 months after the end of administration, subjects with fertility (regardless of men and women) must take effective medical contraceptive measures (for specific contraceptive measures, see Annex 5); 7.Written informed consent can be provided.
Exclusion criteria
Exclusion criteria: 1. Pregnant or lactating women; 2. Subjects with other acquired and congenital immunodeficiency diseases, including but not limited to HIV-infected persons; 3. Subjects with a history of deep vein thrombosis (DVT) or pulmonary embolism (PE) within the past twelve months; 4. Clinically significant heart disease, including unstable angina pectoris, acute myocardial infarction 6 months before randomization, congestive heart failure (NYHA) cardiac function class III or IV; or cardiac left ventricular ejection fraction < 50%; 5. Those who are known to be allergic to the components of the test drug; 6. Patients with grade 3 or higher neurotoxicity within two weeks before treatment; 7. Combined with severe infection; 8. Those who are deemed unsuitable for inclusion by the researcher.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| objective response rate; | — |
Secondary
| Measure | Time frame |
|---|---|
| progression free survival;duration of remission;time to remission; | — |
Countries
China
Contacts
Public ContactSang Wei
The Affiliated Hospital of Xuzhou Medical University
Outcome results
None listed