central nervous system lymphoma
Conditions
Interventions
Experimental group:Mitoxantrone liposome+Ifosfamide+Mesna+Etoposide+CD20 antibody
Sponsors
The Second Hospital of Nanjing
Eligibility
Sex/Gender
All
Age
18 Years to No maximum
Inclusion criteria
Inclusion criteria: 1. Histopathologically confirmed relapsed/refractory primary CNS lymphoma should be avoided if the condition permits. Glucocorticoids should be avoided until pathological tissue is obtained, if possible. 2. Patients with first symptoms of CNS (brain tissue, meninges, spinal cord, and eyes) damage should be avoided. The first symptoms of the patient were mainly damage to the central nervous system (brain tissue, meninges, spinal cord and eyes). The first symptoms were mainly damage to the central nervous system (brain tissue, meninges, spinal cord and eyes). 3. Eastern Tumor Collaborative Group physical status score of 0-3. 4. Age: 18-75 years. 5. expected survival time >= 3 months. 6. Female subjects of childbearing age or male subjects whose sexual partners are women of childbearing age are required to be treated throughout the treatment period and after the last treatment. 6. Female subjects of childbearing age or male subjects whose sexual partners are women of childbearing age are required to use effective contraception throughout the treatment period and for 90 days after the last treatment. 7. Imaging-enhanced MRI showing at least 1 measurable lesion in the central nervous system (>= 1.0 cm in length and diameter) 1.0 cm). 8. have adequate organ and bone marrow function, defined as follows. (1) neutrophil count >= 1.5 x 10^9 /L, platelet count >= 75 x 10^9 /L, hemoglobin >= 80 g/L. (2) liver and kidney function: serum creatinine <= 1.5 times the upper limit of normal value; AST and ALT <= 2.5 times the upper limit of normal value; total bilirubin (2) liver and kidney function: serum creatinine <= 1.5 times the upper limit of normal value; AST and ALT <= 2.5 times the upper limit of normal value; total bilirubin <= 1.5 times the upper limit of normal value
Exclusion criteria
Exclusion criteria: 1. The subject's prior history of antitumor therapy meets one of the following criteria; (1) Previous recipient of mitoxantrone or mitoxantrone liposomes; (2) Previous treatment with adriamycin or other anthracyclines with a total cumulative dose of adriamycin > 360mg/m2 (conversion of other anthracyclines 1 mg adriamycin is equivalent to 2 mg epirubicin); (3) Received antitumor therapy (including chemotherapy, targeted therapy, hormonal therapy, or anti-tumor drugs) within 4 weeks prior to the first use of this study drug; (4) Received antitumor therapy (including chemotherapy, targeted therapy, hormone therapy, herbal medicine with antitumor activity, etc.) or participated in other clinical trials within 4 weeks before the first use of this study drug and received drugs for clinical trials; 2. Hypersensitivity reaction to any investigational drug or its components; 3. Uncontrollable systemic disease (e.g., progressive infection, uncontrollable hypertension, diabetes mellitus etc.); 4. Cardiac function and disease consistent with one of the following; (1) Long QTc syndrome or QTc interval > 480 ms; (2) Complete left bundle branch block, degree II or III atrioventricular block; (3) Severe, uncontrolled arrhythmias requiring pharmacological treatment; (4) American New York Heart Association classification >= Class III; (5) Cardiac ejection fraction (LVEF) less than 50%; (6) history of myocardial infarction, unstable angina, severe unstable ventricular arrhythmia, or any other history of myocardial infarction, unstable angina, severe unstable ventricular arrhythmia or any other arrhythmia requiring treatment, clinically significant pericardial disease within 6 months prior to recruitment. History of myocardial infarction, stable angina, severe unstable ventricular arrhythmia or any other arrhythmia requiring treatment, clinically significant pericardial disease, or ECG evidence of acute ischemic or active conduction abnormalities; 5. Active hepatitis B or C infection (one positive for hepatitis B surface antigen or core antibody, plus testing for HBV DNA, hepatitis B virus DNA more than 1x10 3 copies/mL excluded; if hepatitis C antibody positive, add HCV RNA test. If positive for hepatitis C antibody, add HCV RNA and exclude hepatitis C virus RNA over 1x10 3 copies/mL); 6. Baseline NT-proBNP greater than 400 pg/ml, cTnI greater than the center's upper limit of normal, three days Retesting is still above the above range; 7. Human immunodeficiency virus (HIV) infection (HIV antibody positive); 8. previous or current concurrent other active malignancies (except for effectively controlled non-melanoma 8. previous or current other active malignancies (in addition to effectively controlled non-melanoma basal cell carcinoma of the skin, breast/cervical carcinoma in situ, and other malignancies not treated and effectively controlled within the past five years) other malignancies that have been effectively controlled without treatment within the past five years; 9. Patients with severe psychiatric disorders unrelated to the disease; 10. Patients who are judged by the investigator to be unsuitable for participation in this study.
Design outcomes
Secondary
| Measure | Time frame |
|---|---|
| Safety;overall survival;one year PFS;CRR; | — |
Primary
| Measure | Time frame |
|---|---|
| Best Overall response rate; | — |
Countries
China
Contacts
Public ContactJingjing Guo
Outcome results
None listed