Primary central nervous system lymphoma
Conditions
Interventions
experimental group:Rituximab combined with high-dose methotrexate and obitinib
Sponsors
Affiliated Tumor Hospital of Xinjiang Medical University
Eligibility
Sex/Gender
All
Age
60 Years to 80 Years
Inclusion criteria
Inclusion criteria: 1. Pathology: Primary central nervous system lymphoma confirmed by histology; 2. Aged 60-80 years; 3. ECOG PS score: 0-2 (Patients scored 3 by ECOG due to tumors after full evaluation by the investigator can also be included); 4. Imaging MRI and PET/CT show at least 1 measurable lesion in the central nervous system, except for the case without measurable lesion; 5. Sign the Consent Form and comply with the visits and related procedures stipulated in the plan; 6. Estimated survival time >= 3 months; 7. Cardiac function: echocardiography LVEF >= 50%; 8.The function of bone marrow and organs must meet the following conditions: (1) Absolute value of neutrophils >= 1.5 x 10^9/L (2) Platelets >= 75 x 10^9/L (no platelet transfusion within 14 days before use of study drugs (3) Hemoglobin >= 80 g/dL (no red blood cell transfusion within the 14 days before the use of study drugs (4) ALT and AST <= 3 × ULN (5) Total bilirubin <= 1.5×ULN7 (6) Serum creatinine <= 2×ULN (7) International normalized ratio=1.5×ULN, prothrombin time, activated partial thromboplastin time = 1.5 × ULNLipase=1.5×ULN (8) Lipase = 1.5 × ULN.
Exclusion criteria
Exclusion criteria: 1. The patient diagnosed as malignant tumor other than the primary central diffuse large B-cell lymphoma, or received anti-lymphoma treatment, including those who have previously received stem cell transplantation. 2. Heart disease with obvious clinical symptoms, including the uncontrolled symptoms such as arrhythmia, congestive heart failure (> grade 2), unstable angina, myocardial infarction within 6 months beforethe study treatment, or any grade 3 or 4 heart disease determined by the functional classification system of the New York Heart Association. 3. Hypertension out of control after treatment (determined by the investigator). 4. Diabetes under poor control after treatment (determined by the investigator). 5. Any uncontrolled active systemic infection (>CTCAE grade 2), which requires intravenous antibiotic treatment within 14 days before the use of study drugs. 6. Cerebrovascular accident, deep vein thrombosis or pulmonary embolism within 3 months before the study treatment. 7. Wounds, ulcersand bone fractures which cannot heal within a short time. 8. History of severe hemorrhagic disease, such as hemophilia A, hemophilia B, von Willebranddisease, or spontaneous hemorrhage that requires blood transfusion or other medical intervention, hemorrhagic constitutionor hemophilia. 9. Those with known history of human immunodeficiency virus (HIV) infection or active hepatitis C virus (HCV) or hepatitis B virus (HBV).Note: HCV antibody-positive subjects who have received treatment with long-lasting virological response (the virus test is negative for at least 6 months after the treatment) will not be excluded. 10.Those whoreceived major surgery within 2 weeks before the study drug treatment, or have not recovered from adverse reactions caused by the surgery. 11.Those who cannot swallow capsules, or have the diseases which seriously affect gastrointestinal function.6.12Life-threatening diseases, illnesses or organ dysfunctions that may endanger the safety of subjects or put research results at risk6 13.Those who need warfarin or equivalent vitamin K antagonist for anticoagulant therapy; need strong CYP3A4/5 inhibitor for treatment. 14.Those who need long-term dexamethasone >= 4mg/day or equivalent hormone preparations. 15.Those who needimmunosuppressive therapy, including cyclosporine A, Tacrolimus and Sirolimus. The patients should stop the use of immunosuppressive agents 28 days before the study drug treatment.6.16Those with known history of primary immunodeficiency 17. Those with known to have active tuberculosis. 18.Those with known history of allogeneic organ transplantation and allogeneic hematopoietic stem cell transplantation. 19.Those need continuous reception of strong CYP3A inhibitors or inducers (see Appendix 2)6.20Those who have received autologous stem cell transplantation.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Objective response rate; | — |
Secondary
| Measure | Time frame |
|---|---|
| progression-free survival, PFS;safety;Overall Survival,OS;Objective remission rate;Overall survival; | — |
Countries
China
Contacts
Public ContactShujuan Wen
Affiliated Tumor Hospital of Xinjiang Medical University
Outcome results
None listed