Construction of Diagnosis and Treatment System for Primary Vitreoretinal Lymphoma

July 11, 2023 updated by: Peking Union Medical College Hospital

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.

Study Overview

Status

Recruiting

Conditions

Intervention / Treatment

Study Type

Observational

Enrollment (Estimated)

100

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

Study Locations

  • China
    • Beijing
      • Beijing, Beijing, China
        • Recruiting
        • Peking Union Medical College Hospital
        • Contact:

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

  • Adult
  • Older Adult

Accepts Healthy Volunteers

Yes

Sampling Method

Probability Sample

Study Population

Newly diagnosed PVRL patients admitted to the Ophthalmology or Hematology departments of Peking Union Medical College Hospital from 2022 to 2024.

Description

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.

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

Cohorts and Interventions

Group / Cohort
Intervention / Treatment
Group A
Cerebrospinal fluid IL-10 was normal
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

Other Names:
  • Intravitreal injection of methotrexate+systemic therapy
Group B
Cerebrospinal fluid IL-10 was normal or elevated
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

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）
Time Frame: 1 year
aqueous fluid
1 year
Interleukin-10/Interleukin-6（IL-10/IL-6）
Time Frame: 2.5 years
cerebrospinal
2.5 years

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Peking Union Medical College Hospital

Collaborators

Beijing Tongren Hospital
Southern Medical University

Investigators

  • Study Chair: Meifen Zhang, Peking Union Medical College Hospital

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

October 1, 2022

Primary Completion (Estimated)

December 1, 2024

Study Completion (Estimated)

September 1, 2025

Study Registration Dates

First Submitted

July 11, 2023

First Submitted That Met QC Criteria

July 11, 2023

First Posted (Actual)

July 18, 2023

Study Record Updates

Last Update Posted (Actual)

July 18, 2023

Last Update Submitted That Met QC Criteria

July 11, 2023

Last Verified

July 1, 2023

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

  • 2022-PUMCH-C-038

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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