vitreoretinal lymphoma
Conditions
Interventions
experimental group :Ibrutinib 560mg qd or zanubrutinib 160mg bid orally
Sponsors
Beijing Tongren Hospital affiliated to Capital Medical University
Eligibility
Sex/Gender
All
Age
18 Years to No maximum
Inclusion criteria
Inclusion criteria: 1. Patients with diffuse large B-cell lymphoma diagnosed by vitreous histopathology, and excluding systemic lymphoma associated with eye involvement by PET-CT; patients with intracranial infiltration indicated by brain MRI can be included; 2. Patients with newly diagnosed or relapsed refractory vrl (i.e. relapse after intravitreal injection of MTX or eye radiotherapy for pvrl); 3. Patients with indicators that can evaluate the curative effect (vitreous opacity, lymphoma lesions visible on Oct, increased IL-10 value in intraocular fluid and IL-10 / IL-6 > 1); 4. Patients with an estimated survival time of more than 3 months; 5. Patients aged >= 18 years old; 6. Patients with PS between 0-3 of ECoG score; 7. After the patients are enrolled in the trial, they are not allowed to accept other drugs that may have therapeutic effect on vrl (including but not limited to intravitreal injection of MTX or radiotherapy or systemic high-dose MTX); 8. White blood cell count >=3x10^9/L, neutrophil count >= 1.5x10^9/L, platelet count >= 50 x 10^9/L; 9. Patients with serum creatinine = 50ml/ min; 10. Patients with ALT, AST <= 3 ULN, total bilirubin <= 2 ULN; 11. Patients with informed consent.
Exclusion criteria
Exclusion criteria: 1. Patients with other active malignant tumors at present; 2. The general condition of the patients was very poor, and the PS score was more than 3 points; 3. Women in pregnancy or lactation period; 4. The patients (male or female) have the possibility of fertility, but they are not willing to take effective contraceptive measures; 5. Patients who are known to be allergic to the test drug or to any of the formulation components of these products; 6. Patients with active infection (determined by the researcher); 7. Patients with underlying diseases with uncontrollable atrial fibrillation or heart failure; 8. According to the judgment of the researcher, there are accompanying diseases that seriously endanger the safety of patients or affect patients to complete the study; 9. Patients with a clear history of neurological or mental disorders, including epilepsy or dementia.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Disease Control Rate; | — |
Secondary
| Measure | Time frame |
|---|---|
| Event-free survival;Overall survival;Adverse Event;Serious Adverse Event; | — |
Countries
China
Contacts
Public ContactPeng Xiaoyan
Beijing Tongren Hospital Ophthalmology
Outcome results
None listed