RecruitingNCT05950490Updated Jul 18, 2023

Construction of Diagnosis and Treatment System for Primary Vitreoretinal Lymphoma

An observational study in Primary Vitreoretinal Lymphoma, sponsored by Peking Union Medical College Hospital. Recruiting at 1 site in China. Open to participants aged 18 Years to 75 Years, including healthy volunteers. Per ClinicalTrials.gov, last updated 2023-07-18.

Sponsored by Peking Union Medical College Hospital · Observational

Study type: Observational
Model: Cohort
Time perspective: Prospective
Enrollment: 100
Ages: 18 Years to 75 Years
Sex: All

Study 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:

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

Conditions studied

Primary Vitreoretinal Lymphoma

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Who can participate

Ages eligible: 18 Years to 75 Years
Sexes eligible: All
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.

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

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 design

Observational model: Cohort
Time perspective: Prospective
Enrollment: 100 participants (estimated)
Target follow-up: 26 Months
Patient registry: Yes

Groups and cohorts

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

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
Also known as: Intravitreal injection of methotrexate+systemic therapy

What researchers measure

Primary outcomes

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

Study locations

1 of 1 sites recruiting

Peking Union Medical College Hospital
Beijing, Beijing, China
- Yujing Qian · Contact · qianyujing777@126.com · +8615901597377
Recruiting

Registry details

Key details

Study ID: NCT05950490
Lead sponsor: Peking Union Medical College Hospital
Collaborators: Beijing Tongren Hospital, Southern Medical University
Responsible party: Sponsor
First posted: Jul 18, 2023
Start date: Oct 1, 2022
Primary completion: Dec 2024 (estimated)
Completion: Sep 2025 (estimated)
Last update: Jul 18, 2023

Study contacts

Yujing Qian

Contact

qianyujing777@126.com

+86 15901597377

Meifen Zhang

study chair · Peking Union Medical College Hospital

Oversight

Data monitoring committee: No
FDA-regulated drug: No
FDA-regulated device: No

View the source record on ClinicalTrials.gov ↗

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