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Construction of Diagnosis and Treatment System for Primary Vitreoretinal Lymphoma

Sponsor
Peking Union Medical College Hospital (Other)
Overall Status
Recruiting
CT.gov ID
NCT05950490
Collaborator
Beijing Tongren Hospital (Other), Southern Medical University (Other)
100
Enrollment
1
Location
35
Anticipated Duration (Months)
2.9
Patients Per Site Per Month

Study Details

Study Description

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.

Condition or Disease Intervention/Treatment Phase
  • Drug: Intravitreal injection of methotrexate

Study Design

Study Type:
Observational [Patient Registry]
Anticipated Enrollment :
100 participants
Observational Model:
Cohort
Time Perspective:
Prospective
Official Title:
Construction of Diagnosis and Treatment System for Primary Vitreoretinal Lymphoma
Actual Study Start Date :
Oct 1, 2022
Anticipated Primary Completion Date :
Dec 1, 2024
Anticipated Study Completion Date :
Sep 1, 2025

Arms and Interventions

Arm 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

    		•

    Outcome Measures

    Primary Outcome Measures

    1. Interleukin-10/Interleukin-6（IL-10/IL-6） [1 year]

      aqueous fluid

    2. Interleukin-10/Interleukin-6（IL-10/IL-6） [2.5 years]

      cerebrospinal

    Eligibility Criteria

    Criteria

    Ages Eligible for Study:
    18 Years to 75 Years
    Sexes Eligible for Study:
    All
    Accepts 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.

    Contacts and Locations

    Locations

    Site City State Country Postal Code
    1 Peking Union Medical College Hospital Beijing Beijing China

    Sponsors and Collaborators

    • Peking Union Medical College Hospital
    • Beijing Tongren Hospital
    • Southern Medical University

    Investigators

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

    Study Documents (Full-Text)

    None provided.

    More Information

    Publications

    None provided.
    Responsible Party:
    Peking Union Medical College Hospital
    ClinicalTrials.gov Identifier:
    NCT05950490
    Other Study ID Numbers:
    • 2022-PUMCH-C-038
    First Posted:
    Jul 18, 2023
    Last Update Posted:
    Jul 18, 2023
    Last Verified:
    Jul 1, 2023
    Studies a U.S. FDA-regulated Drug Product:
    No
    Studies a U.S. FDA-regulated Device Product:
    No
    Additional relevant MeSH terms:
    Lymphoma
    Intraocular Lymphoma
    Methotrexate

    Study Results

    No Results Posted as of Jul 18, 2023