Construction of Diagnosis and Treatment System for Primary Vitreoretinal Lymphoma

Study Overview
=================
Brief Summary
-----------------
This study intends to apply for the establishment of research beds, establish a Chinese PVRL research cohort, and carry out a to achieve the following research objectives: The goal of this prospective observational study is to construct the diagnosis and treatment system for primary vitreoretinal lymphoma（PVRL）. The study is to achieve the following research objectives: To establish a comprehensive diagnostic criteria for PVRL with high diagnostic efficiency and strengthen the PVRL diagnostic system; To establish a standardized treatment pathway for PVRL and evaluate the efficacy and safety of treatment; To screen the prognosis evaluation indicators, and to establish the follow-up process and prognosis evaluation system of PVRL； To explore the pathogenesis of PVRL, specific tumor markers and drug therapeutic targets.

Official Title
-----------------
Construction of Diagnosis and Treatment System for Primary Vitreoretinal Lymphoma

Conditions
-----------------
Primary Vitreoretinal Lymphoma

Intervention / Treatment
-----------------
* Drug: Intravitreal injection of methotrexate


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Newly diagnosed PVRL patients admitted to the Ophthalmology or Hematology departments of Peking Union Medical College Hospital from 2022 to 2024; 18-75 years old; The diagnosis was confirmed by pathology, aqueous humor/vitreous IL-10/IL-6, vitreous flow cytometry and gene rearrangement.; HIV-Ab negative; Creatinine clearance > 50ml/min; Sign informed consent. Exclusion Criteria: Combined with other tumors; Uncontrolled active infections; Pregnant or lactating women; Antitumor therapy other than the protocol of this study was used.

Ages Eligible for Study
-----------------
Minimum Age: 18 Years
Maximum Age: 75 Years

Sexes Eligible for Study
-----------------
All

Accepts Healthy Volunteers
-----------------
Accepts Healthy Volunteers

Study Plan
=================
How is the study designed?
-----------------

Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Group A<br>Cerebrospinal fluid IL-10 was normal | Drug: Intravitreal injection of methotrexate<br>* Intravitreal injection of methotrexate:400ug/0.1mL，Once a week*4 weeks → Once every two weeks*4 weeks → once a month *10 times(16 times a year) Systemic therapy: Induction period:（Zanubrutinib + Rituximab，ZR） (28 days/cycle) x 6 cycles:Rituximab iv375mg/m2 D1, Zanubrutinib 160mg bid D1-D21; Maintenance treatment:Zanubrutinib 160mg bid x 2 years<br>* Other names: Intravitreal injection of methotrexate+systemic therapy;|
| Group B<br>Cerebrospinal fluid IL-10 was normal or elevated | Drug: Intravitreal injection of methotrexate<br>* Intravitreal injection of methotrexate:400ug/0.1mL，Once a week*4 weeks → Once every two weeks*4 weeks → once a month *10 times(16 times a year) Systemic therapy: Induction period:（Zanubrutinib + Rituximab，ZR） (28 days/cycle) x 6 cycles:Rituximab iv375mg/m2 D1, Zanubrutinib 160mg bid D1-D21; Maintenance treatment:Zanubrutinib 160mg bid x 2 years<br>* Other names: Intravitreal injection of methotrexate+systemic therapy;|

What is the study measuring?
-----------------
Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Interleukin-10/Interleukin-6（IL-10/IL-6） | aqueous fluid | 1 year | 
| Interleukin-10/Interleukin-6（IL-10/IL-6） | cerebrospinal | 2.5 years |