primary central nervous system lymphoma (PCNSL)
Conditions
Interventions
Experimental group:Aubutinib + rituximab + methotrexate + autologous hematopoietic stem cell transplantation
Sponsors
Department of Hematology, Qilu Hospital, Shandong University
Eligibility
Sex/Gender
All
Age
18 Years to 65 Years
Inclusion criteria
Inclusion criteria: 1. Volunteer to participate in clinical studies; Fully understand and understand the study and sign an informed consent form (ICF); Willing to follow and able to complete all research steps. 2. The diagnosis was confirmed by histopathology as diffuse large B-cell lymphoma of primary central nervous system. The patient had not received any systemic therapy against DLBCL prior to enrollment in this trial. 3. Aged 18-65 years. 4. No severe hematopoietic dysfunction, heart, lung, liver, kidney, thyroid dysfunction, or immune deficiency (no blood transfusion, granulocyte colony stimulating factor, or other medical support drugs received in the 7 days prior to starting the study) : (1) Absolute count of neutrophils (ANC) >=1.0x 10^9/L; Platelet (PLT) >=50x 10^9/L; Hemoglobin >80 g/L; (2) Aspartate aminotransferase (AST/SGOT) and alanine aminotransferase (ALT/SGPT) =40ml/min (estimated by Cockcroft-Gault formula); (3) International Normalized ratio (INR) =0.5. 5. Female patients who have no fertility requirements and male patients who use study drugs are not allowed to donate sperm.
Exclusion criteria
Exclusion criteria: 1. Patients who have been diagnosed with other diseases of the blood system, not lymphoma; 2. Other active malignancies and other hematologic diseases requiring concurrent treatment (such as leukemia, hemophilia or primary myelofibrosis); 3. Major surgery within 4 weeks before screening; 4. Clinically significant cardiovascular disease, including: (1) Myocardial infarction occurring within 6 months prior to screening; (2) Unstable angina occurred within 3 months prior to screening; (3) Clinically significant arrhythmias (such as persistent ventricular tachycardia, ventricular fibrillation, tip torsion ventricular tachycardia); (4) History of second degree type II AV block or third degree AV block; (5) Grade III or IV congestive heart failure as defined by the New York Heart Association; 5. History of stroke or intracranial hemorrhage within 6 months prior to initial drug administration; 6. Inability to swallow capsules or medical conditions that significantly affect gastrointestinal function, such as malabsorption syndrome, removal of the stomach or small intestine, symptomatic inflammatory bowel disease, or partial or complete intestinal obstruction; 7. Uncontrolled systemic infections requiring parenteral anti-infective therapy with intravenous administration; 8. Known human immunodeficiency virus (HIV) infection; 9. Contraindications for any drug in this protocol; Known hypersensitivity to methotrexate or rituximab, BTK inhibitors, or chemical or biological analogues of these drugs; 10. The presence of any life-threatening disease, medical condition, or organ system dysfunction that the investigator believes could affect the subject's safety or pose a risk to the study; 11. History of deep vein thrombosis (DVT) or pulmonary embolism (PE) within the past 12 months; 12. Continued treatment with strong and moderate acting CYP3A inhibitors or inducers is required. Patients were not enrolled if they had taken CYP3A potent or moderate-acting inhibitors or inducers within 7 days prior to the first administration of the study drug (or had not taken these drugs for more than 5 half-lives).
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Overall response rate;Complete response rate; | — |
Secondary
| Measure | Time frame |
|---|---|
| Progression free survival;Overall survival rate;Adverse event;Cerebrospinal fluid metabolomics; | — |
Countries
China
Contacts
Public ContactLiu Xin'guang
Department of Hematology, Qilu Hospital, Shandong University
Outcome results
None listed