Primary central nervous system lymphoma
Conditions
Interventions
Maintenance treatment group for high-risk patients:Pomalidomide monotherapy
Elderly (>=60 years old) patient group who were initially intolerant/unsuitable for HD-MTX:Pomalidomide combined with rituximab
Sponsors
Lanzhou University Second Hospital
Eligibility
Sex/Gender
All
Age
18 Years to 100 Years
Inclusion criteria
Inclusion criteria: 1. Aged >= 18 years, gender is not limited; 2. ECOG behavior level =1.5x10^9/L, platelets >= 75 x 10^9/L, hemoglobin >= 80g/L; (2) Blood biochemistry: total bilirubin <= 2 times ULN, AST or ALT <= 2.5 times ULN; serum creatinine < 2 times ULN; (3) Coagulation function: international normalized ratio (INR) and activated partial thrombin time <= 1.5 times ULN; 7. If the subjects have received anti-tumor treatment in the past, they should be enrolled after the toxicity of the previous treatment has recovered to the Common Adverse Event Evaluation Criteria (CTCAE) v4.03 grade score <= grade 1 or the baseline level; Grade 2 toxicities (such as thrombocytopenia, anemia, neurotoxicity, alopecia, and hearing loss) that are irreversible due to tumor treatment and are not expected to worsen during study treatment, can be enrolled with the consent of the investigator; 8. The subjects voluntarily joined the study, understood the test steps and contents, signed the informed consent form, had good compliance, and cooperated with the follow-up.
Exclusion criteria
Exclusion criteria: 1. Patients who cannot receive enhanced MRI evaluation; 2. Patients with secondary central nervous system lymphoma with extensive systemic invasion; 3. The patient is participating in other interventional clinical studies or less than 4 weeks from the end of the previous clinical study; less than 4 weeks after the last antitumor treatment (radiotherapy, chemotherapy, targeted therapy, immunotherapy, or local-regional therapy); received autologous stem cell transplantation within 6 months; and used any immunomodulatory drug treatment within 3 months before enrollment; 4. Uncontrolled or significant cardiovascular disease, including: (1) New York Heart Association (NYHA) class II or above congestive heart failure, unstable angina, myocardial infarction and other cardiovascular diseases within 6 months before the first administration; (2) Primary cardiomyopathy (such as dilated cardiomyopathy, hypertrophic cardiomyopathy, arrhythmogenic right ventricular cardiomyopathy, restrictive cardiomyopathy, indeterminate cardiomyopathy); (3) With history of clinically significant QTc interval prolongation; (4) Uncontrolled hypertension; 5. Patients with known history of interstitial pneumonia or high suspicion of interstitial pneumonia; or patients who may interfere with the detection or management of suspected drug-related pulmonary toxicity; other active malignancies requiring concomitant treatment; history of malignancy. Except for patients with basal cell carcinoma of the skin, superficial bladder cancer, squamous cell carcinoma of the skin, or cervical carcinoma in situ who have undergone potentially curative treatment and have not had disease recurrence within 5 years since the end of treatment; known history of organ transplantation and allogeneic hematopoietic stem cell transplantation; patients who have undergone major surgery or suffered severe trauma, and the effects of surgery or trauma have been eliminated for less than 14 days before enrollment; patients with active pulmonary tuberculosis need to be excluded; 6. There is drug allergy or metabolic disorder to the drugs in this program; 7. Known history of organ transplantation and allogeneic hematopoietic stem cell transplantation; 8. Any mental or cognitive impairment; 9. Those who have a history of drug abuse and alcoholism within 6 months before the first administration; 10. Pregnant or lactating patients, female patients or male patient partners who plan to become pregnant during the study period to 6 months after the last dose, and who are unwilling to use a medically recognized effective contraceptive measure (such as an IUD or condom) during the trial; 11. According to the judgment of the investigator, the patient may have other factors that may cause the study to be terminated midway, such as other serious diseases or serious laboratory abnormalities or accompanied by other factors that will affect the safety of the patients, or the family or society where the test data and samples are collected; 12. The investigator considers other circumstances that are not suitable to participate in this trial.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Objective response rate; | — |
Secondary
| Measure | Time frame |
|---|---|
| Progression-free survival;Disease control rate;Remission duration time;Essential information;Adverse event;Cerebrospinal fluid (CSF) related tests;Eye related examination; | — |
Countries
China
Contacts
Public ContactWu Chongyang
Lanzhou University Second Hospital
Outcome results
None listed