Construction of Diagnosis and Treatment System for Primary Vitreoretinal Lymphoma

Status

UNKNOWN

Phases

Unknown

Study type

Observational

Source

ClinicalTrials.gov

Registry ID

NCT05950490

Enrollment

100

Registered

2023-07-18

Start date

2022-10-01

Completion date

2025-09-30

Last updated

2023-07-18

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Primary Vitreoretinal Lymphoma

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: 1. To establish a comprehensive diagnostic criteria for PVRL with high diagnostic efficiency and strengthen the PVRL diagnostic system; 2. To establish a standardized treatment pathway for PVRL and evaluate the efficacy and safety of treatment; 3. To screen the prognosis evaluation indicators, and to establish the follow-up process and prognosis evaluation system of PVRL； 4. To explore the pathogenesis of PVRL, specific tumor markers and drug therapeutic targets.

Interventions

DRUGIntravitreal injection of methotrexate

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

Study design

Observational model

COHORT

Time perspective

PROSPECTIVE

Eligibility

Sex/Gender

ALL

Age

18 Years to 75 Years

Healthy volunteers

Yes

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.

Design outcomes

Primary

Measure	Time frame	Description
Interleukin-10/Interleukin-6（IL-10/IL-6）	1 year	aqueous fluid

Countries

China

Contacts

Primary ContactYujing Qian

qianyujing777@126.com+86 15901597377

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026