Construction of Diagnosis and Treatment System for Primary Vitreoretinal Lymphoma

NCT05950490 | Unknown

• 1 other identifier: 2022-PUMCH-C-038
• Study Type: observational
• Target: 100
• Locations: 1 country
• Sites: 1

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

Conditions

Primary Vitreoretinal Lymphoma

Outcome Measures

Primary Outcomes (2)

• Interleukin-10/Interleukin-6（IL-10/IL-6）

  aqueous fluid

  1 year

• Interleukin-10/Interleukin-6（IL-10/IL-6）

  cerebrospinal

  2.5 years

Study Arms (2)

Group A

Cerebrospinal fluid IL-10 was normal

Drug: Intravitreal injection of methotrexate

Group B

Cerebrospinal fluid IL-10 was normal or elevated

Drug: Intravitreal injection of methotrexate

Interventions

Intravitreal injection of methotrexate DRUG

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

Also known as: Intravitreal injection of methotrexate+systemic therapy

Group A; Group B

Eligibility Criteria

• Age: 18 Years - 75 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)
• 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.

You may qualify if:

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

You may not qualify if:

• Combined with other tumors;
• Uncontrolled active infections;
• Pregnant or lactating women;
• Antitumor therapy other than the protocol of this study was used.

Sponsors & Collaborators

• Peking Union Medical College Hospital: lead
• Beijing Tongren Hospital: collaborator
• Southern Medical University: collaborator

Study Sites (1)

Peking Union Medical College Hospital

Beijing, Beijing Municipality, China

RECRUITING

Study Officials

• Meifen Zhang

  Peking Union Medical College Hospital

  STUDY CHAIR

Central Study Contacts

Yujing Qian

CONTACT

+86 15901597377; qianyujing777@126.com

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: PROSPECTIVE
• Target Duration: 26 Months
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: July 11, 2023
• First Posted: July 18, 2023
• Study Start: October 1, 2022
• Primary Completion: December 1, 2024
• Study Completion: September 1, 2025
• Last Updated: July 18, 2023

Record last verified: 2023-07

Locations

CN (1)