primary central nervous system large B-cell lymphoma
Conditions
Interventions
Interventions group:MEDZ-R regimen (rituximab 375 mg/m2 d0 + methotrexate 3.5 g/m2 d1 (infused for 3 hours, 12 times of rescue with calcium folinate 100 mgq6h starting from the 24th hour of MTX infusi
Sponsors
West China Hospital, Sichuan University
Eligibility
Sex/Gender
All
Age
18 Years to 70 Years
Inclusion criteria
Inclusion criteria: 1. Be able to sign the written informed consent and understand and comply with the research requirements. 2. Age =18 years old and less than 70 years old, no gender restrictions. 3. Histologically confirmed diffuse large B-cell lymphoma (DLBCL). 4. Previously untreated PCNSL and secondary central nervous system lymphoma. 5. For patients with brain parenchymal involvement, clear imaging evidence of disease progression (such as MRI and head CT) is required before enrollment. For patients with only leptomeningeal involvement, lymphoma cells were required to be detected in CSF cytology before enrollment. 6. The Eastern Cooperative Oncology Group (ECOG) performance status score was 0-2. 7. Adequate hematologic and organ function is defined as: (1) Absolute neutrophil count (ANC) = 0.75 × 109 /L within 7 days before the first dose of study medication and no granulocyte stimulating factor support therapy (2) Platelet count = 75 × 109 /L within 7 days before the first dose of study medication and no platelet growth factor support or platelet transfusion. (3) Creatinine clearance = 30 ml/min (estimated by the Cockcroft-Gault formula or measured by nuclear medicine scan or 24-hour urine collection) (4) Aspartate aminotransferase (AST) and alanine aminotransferase (ALT) = 2.5 × upper limit of normal (ULN) (5) Bilirubin = 1.5 × ULN (6) International normalized ratio (INR) = 1.5 × ULN and activated partial thromboplastin time (aPTT) = 1.5 × ULN 8. Agree to use effective contraceptive measures during the study period and for at least 90 days after the last dose of the study
Exclusion criteria
Exclusion criteria: ? Evidence of active systemic disease outside the CNS (assessed by PET/CT and bone marrow examination). ? Concurrently use other approved or under-development anti-tumor drugs for treatment. ? Patients had received chemotherapy, targeted therapy and/or radiotherapy, or autologous stem cell transplantation 4 weeks before screening. ? History of other active malignant diseases within 2 years before entering the study. ? Those who have undergone major surgery within 4 weeks before screening or have not recovered from side effects of such major surgery. ? Known human immunodeficiency virus (HIV) infection, or the following serologic status reflecting active hepatitis B or C virus infection ? Active infections, including those that require oral or intravenous antibiotics. ? Have clinically significant cardiovascular disease, including: a. Myocardial infarction within 6 months before screening b. Unstable angina occurring within 3 months before screening c. Clinically significant arrhythmias (eg, sustained ventricular tachycardia, ventricular fibrillation, torsades de pointes) d. QTcF (corrected by Fridericia formula) >480 msec e. History of type II second-degree atrioventricular (AV) block or third-degree AV block f. New York Heart Association (NYHA) Class III or IV congestive heart failure (see Appendix 3) g. Echocardiography (ECHO) showed left ventricular ejection fraction (LVEF) less than 50% 11. QTcF>480 msecs or other significant ECG abnormalities ? Inability to swallow capsules or presence of a disorder that significantly affects gastrointestinal function, such as malabsorption syndrome, gastric or small bowel resection, symptomatic inflammatory bowel disease, or partial or complete intestinal obstruction. ? The presence of any life-threatening disease, medical condition, or organ system dysfunction that the investigator believes may affect the subject's safety or cause research risks. ? Requires uninterrupted treatment with a strong or moderate CYP3A inhibitor or inducer. Subjects were not eligible for enrollment if they had taken strong or moderate CYP3A inhibitors or inducers within 7 days prior to study drug administration (or had taken these drugs for less than 5 half-lives). ? History of stroke or intracranial hemorrhage within 6 months before enrollment. ? Inability to comply with study procedures. ? Pregnant or breastfeeding women.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| CR; | — |
Secondary
| Measure | Time frame |
|---|---|
| PFS;ORR;TTR;DOR; | — |
Countries
China
Contacts
Public ContactLiqun Zou
West China Hospital, Sichuan University
Outcome results
None listed