B-cell lymphoma
Conditions
Interventions
therapy group:therapy of XPO1 inhibitor combined with BTK inhibitor and HDMTX
Sponsors
The Second Hospital of Dalian Medical University
Eligibility
Sex/Gender
All
Age
18 Years to 65 Years
Inclusion criteria
Inclusion criteria: 1.Age =18 years old and =65 years old. 2.Primary CNS lymphoma (PCNSL) confirmed by pathology, or secondary CNS lymphoma (SCNSL) that requires histopathological diagnosis as diffuse large B-cell lymphoma (DLBCL). 3.Relapsed or refractory PCNSL or SCNSL, for CNS lesions, need to have received = 1 chemotherapy or targeted therapy, and the number of systemic treatments = 4 times. 4.Cranial MRI or cranial CT showing solid lesions of disease progression; only patients with meningeal disease require CSF cytological examination to confirm lymphoma cells and/or imaging findings consistent with CSF examination. 5.ECOG physical fitness score of 0-2 points. 6.The expected survival time exceeds 3 months. 7.The function of major organs meets the following criteria: a) Blood routine without growth factor support therapy or blood transfusion within 7 days: absolute value of neutrophils =1.0×109/L, platelets =75×109/L, hemoglobin = 80g/L; b) Blood biochemistry: total bilirubin = 2 times ULN, AST or ALT = 2.5 times ULN; serum creatinine < 2 times ULN; c) Coagulation function: international normalized ratio (INR) and activated partial thrombin time =1.5 times ULN. 8.Voluntarily signed a written informed consent.
Exclusion criteria
Exclusion criteria: 1.Participate in another clinical trial and apply the research drug within 4 weeks before the first dose. 2.Daily use of >5mg dexamethasone or equivalent drugs to control CNS disease, or continuous use of systemic adrenal corticosteroids within 14 days before treatment to control non-CNS disease. 3.Suffering from other tumors at the same time and need active treatment. 4.Active bleeding within 4 weeks before the first dose or need to receive anticoagulation therapy such as warfarin or vitamin K antagonist during the study, or the investigator believes that there is a tendency to bleeding (such as esophageal varices with bleeding risk, esophageal varices locally active ulcer lesions) or coagulation disorders. 5.Uncontrolled or important cardiovascular disease, including (but not limited to): a) Any of the following within 6 months before the first dose: congestive heart failure (NYHA class III or IV), myocardial infarction, Unstable angina, or arrhythmia requiring treatment at screening, left ventricular ejection fraction (LVEF) 470 msec (female) or > 450 msec (male); d) atrial fibrillation (EHRA grade = 2b); e) uncontrolled hypertension, judged by the investigator to be unsuitable to participate in this study. 6.Uncontrolled infections or infections requiring intravenous antibiotic treatment. 7.Biopsy within 1 week or surgery within 6 weeks before the first administration of the investigational drug (but the examination for the purpose of diagnosis is not considered as a surgery), the insertion of a vascular access device will be exempted from this exclusion criteria. 8.Clinically obvious gastrointestinal abnormalities that may affect the intake, transport or absorption of drugs (such as active gastrointestinal inflammation, chronic diarrhea, intestinal obstruction, etc.), or total gastrectomy or gastric banding surgery . 9.For female subjects, currently pregnant or breastfeeding. 10.History of stroke, intracranial hemorrhage within 6 months before the first administration, intracranial hemorrhage of postoperative sequelae 11.except. 12.The investigator believes that the subjects participating in the trial are affected by their existing renal disease, neurological/mental disease, liver disease or endocrine disease, or other diseases are judged by the investigator to be inappropriate to participate in the researcher.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Overall Response Rate (ORR);Complete Response(CR); | — |
Secondary
| Measure | Time frame |
|---|---|
| Progress free survival (PFS);Overall Survival(OS);Adverse Event Rate; | — |
Countries
China
Contacts
Public ContactLi Li
The Second Affiliated Hospital of Dalian Medical University
Outcome results
None listed