NCT05950490

Construction of Diagnosis and Treatment System for Primary Vitreoretinal Lymphoma

• Status: Unknown
• Phase: —
• Study type: Observational
• Enrollment: 100 (estimated)
• Sponsor: Peking Union Medical College Hospital · Academic / Other
• Sex: All
• Age: 18 Years – 75 Years
• Healthy volunteers: Accepted

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.

Conditions

• Primary Vitreoretinal Lymphoma

Interventions

Type	Name	Description
DRUG	Intravitreal 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

Timeline

• Start date: 2022-10-01
• Primary completion: 2024-12-01
• Completion: 2025-09-01
• First posted: 2023-07-18
• Last updated: 2023-07-18

Locations

1 site across 1 country: China