primary central nervous system lymphoma
Conditions
Interventions
Case series:Ibrutinib + Rituximab + Methotrexate
Sponsors
Xuan Wu Hospital, Capital Medical University
Eligibility
Sex/Gender
All
Age
18 Years to 70 Years
Inclusion criteria
Inclusion criteria: (1) primary central nervous system diffuse large B-cell lymphoma histologically confirmed by brain biopsy; (2) Aged 18-65 years; (3) Signature of informed consent; (4) At least one measurable lesion; (5) ECOG 0-4; (6) Leucocytes>=1.5x10^9/L,Hemoglobin>=80g/L, platelets>=75x10^9/L, Bilirubin =50%; (8) For men or women of childbearing age who have not undergone sterilization, consent to effective contraception during treatment and within 12 months after the last study drug administration; (9) The expected survival time is at least 6 months.
Exclusion criteria
Exclusion criteria: Patients who meet any of the following exclusion criteria will be excluded: (1) Participated in other clinical trials within 3 months before enrollment. Patients participating in non-intervention studies are eligible to participate in this study; (2) received blood transfusion, erythropoietin (EPO), granulocyte colony stimulating factor (G-CSF) or granulocyte-macrophage colony stimulating factor (GM-CSF) treatment within 14 days before enrollment; (3) Patients who are planned to be vaccinated with live virus, or patients who have been vaccinated within 28 days (or 5 half-life of the vaccine) before enrollment; (4) History of gastrointestinal perforation and / or fistula within 6 months before enrollment; (5) Those who have contraindications to any of the components in the Ibutinib-R-HD-MTX scheme; (6) Have previously received treatment for lymphoma, including: chemotherapy, immunotherapy, local radiotherapy for lymphoma, surgical treatment (except tumor or pathological tissue biopsy and surgical removal not for lymphoma) and the first 3 Used any BTK inhibitor treatment during the month; (7) History of other malignancies that may affect the compliance of the research protocol or the analysis of the results (there are cured skin cells that have cured and have not relapsed within 3 years before enrollment, or skin melanoma or cervical Patients with a history of carcinoma in situ can be enrolled); (8) Combining severe non-malignant tumor diseases that can affect compliance with the study protocol, such as severe cardiovascular disease (such as New York Heart Association Class III or IV heart disease, myocardial infarction or unstable type within the last 6 months) Arrhythmia or unstable angina), uncontrolled diabetes and hypertension; (9) Known uncontrolled active infectious disease or any major infection event requiring intravenous antibiotic treatment or hospitalization (excluding tumor fever) within 4 weeks before enrollment; (10) Human immunodeficiency virus (HIV) antibody is positive; (11) Hepatitis C virus (HCV) antigen or antibody is positive; (12) Hepatitis B virus (HBV) surface antigen positive, and HBV-DNA> 10^3 copy number; (13) Researchers consider if anyone not suitable for enrollment.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Overall response rate (ORR); | — |
Secondary
| Measure | Time frame |
|---|---|
| Adverse event;Progression free survival;Event-free survival;Overall survival rate;Complete response rate; | — |
Countries
China
Contacts
Public ContactSu Li
Xuan Wu Hospital,Capital Medical University
Outcome results
None listed