Primary central nervous system lymphoma
Conditions
Interventions
Group 1:Orbrutinib, monotherapy or in combination with chemotherapy (150 mg daily, continuously)
Group 2:Orelabrutinib, IR2 regimen
Group 3:Orbrutinib, monotherapy maintained for more than 1 year (150 mg daily, continuous use)
Sponsors
The Second Hospital of Lanzhou University
Eligibility
Sex/Gender
All
Age
18 Years to 75 Years
Inclusion criteria
Inclusion criteria: 1. Aged 18-75 years, gender is not limited; 2. ECOG behavior level =1.5x10^9/L, platelets >=75x10^9/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 undergo enhanced MRI evaluation and patients with secondary central nervous system lymphoma with extensive systemic invasion; 2. 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 from the last anti-tumor treatment (radiation, chemotherapy, targeted therapy, immunotherapy, or local-regional therapy); received autologous stem cell transplantation within 6 months; and used any BTK inhibitor therapy within 3 months before enrollment; 3. 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) A history of clinically significant QTc interval prolongation; (4) Uncontrolled hypertension; 4. 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. Excludes 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; subjects 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 should be excluded; 5. There is drug allergy or metabolic disorder to the drugs in this program; 6. Known history of organ transplantation and allogeneic hematopoietic stem cell transplantation; 7. Any mental or cognitive impairment; 8. Those who have a history of drug abuse or alcoholism within 6 months before the first administration; 9. Pregnant or lactating patients, or patient' partners who plan to become pregnant during the study period to 6 months after the last dose, and those who are unwilling to use a medically recognized effective contraceptive measure (such as an IUD or condom) during the trial; 10. According to the judgment of the investigator, the patient may have other factors that may cause the study to be terminated halfway, such as other serious diseases or serious laboratory abnormalities or other factors that may affect the safety of the subjects, or family or social factors such as test data and sample collection; 11. 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;Number of patients with adverse events;Disease control rate;Date of release;Essential information;Cerebrospinal fluid related indicators;Eye related detection indicators; | — |
Countries
China
Contacts
Public ContactWu Chongyang
The Second Hospital of Lanzhou University
Outcome results
None listed