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Trial Title:
Construction of Diagnosis and Treatment System for Primary Vitreoretinal Lymphoma
NCT ID:
NCT05950490
Condition:
Primary Vitreoretinal Lymphoma
Conditions: Official terms:
Lymphoma
Intraocular Lymphoma
Methotrexate
Study type:
Observational [Patient Registry]
Overall status:
Recruiting
Study design:
Time perspective:
Prospective
Intervention:
Intervention type:
Drug
Intervention name:
Intravitreal injection of methotrexate
Description:
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
Arm group label:
Group A
Arm group label:
Group B
Other name:
Intravitreal injection of methotrexate+systemic therapy
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.
Criteria for eligibility:
Study pop:
Newly diagnosed PVRL patients admitted to the Ophthalmology or Hematology departments of
Peking Union Medical College Hospital from 2022 to 2024.
Sampling method:
Probability Sample
Criteria:
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.
Gender:
All
Minimum age:
18 Years
Maximum age:
75 Years
Healthy volunteers:
Accepts Healthy Volunteers
Locations:
Facility:
Name:
Peking Union Medical College Hospital
Address:
City:
Beijing
Country:
China
Status:
Recruiting
Contact:
Last name:
Yujing Qian
Phone:
+8615901597377
Email:
qianyujing777@126.com
Start date:
October 1, 2022
Completion date:
September 2025
Lead sponsor:
Agency:
Peking Union Medical College Hospital
Agency class:
Other
Collaborator:
Agency:
Beijing Tongren Hospital
Agency class:
Other
Collaborator:
Agency:
Southern Medical University
Agency class:
Other
Source:
Peking Union Medical College Hospital
Record processing date:
ClinicalTrials.gov processed this data on November 12, 2024
Source: ClinicalTrials.gov page:
https://clinicaltrials.gov/ct2/show/NCT05950490
