Primary Vitreoretinal LymphomaNCT05950490
Construction of Diagnosis and Treatment System for Primary Vitreoretinal Lymphoma
An observational study of Primary Vitreoretinal Lymphoma, run by Peking Union Medical College Hospital at 1 site in China.
Trial 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）. Read more about this study
- Who is it for?
- Ages 18 to 75 yearsHealthy volunteers can take part
- Conditions the study is for
- Primary Vitreoretinal Lymphoma
- What is being tested?
- Intravitreal injection of methotrexate
- Type of treatment
- Injection or infusion
- How many people
- 100 participants
- Where
- 1 siteChina
- Study dates
- 1 Oct 2022to Sep 2025
- How long will I take part?
- 26 Months
- Phase
- Observational
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 75 years
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Study population: Newly diagnosed PVRL patients admitted to the Ophthalmology or Hematology departments of Peking Union Medical College Hospital from 2022 to 2024.
Who may be able to join
- 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.
Who cannot join
- Combined with other tumors;
- Uncontrolled active infections;
- Pregnant or lactating women;
- Antitumor therapy other than the protocol of this study was used.
Trial locations and contacts
1 site in 1 country.
China1 site, 1 recruiting
- Recruiting
Peking Union Medical College Hospital
Beijing, Beijing Municipality
Yujing Qian, +8615901597377, qianyujing777@126.com
About this study
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
- Primary Vitreoretinal Lymphoma
- Being tested
- Intravitreal injection of methotrexate
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Intravitreal injection of methotrexateDrug
Also called Intravitreal injection of methotrexate+systemic therapy
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
| Study group | Role | What they receive |
|---|---|---|
| Group A | Cerebrospinal fluid IL-10 was normal Receives: Drug: Intravitreal injection of methotrexate | |
| Group B | Cerebrospinal fluid IL-10 was normal or elevated Receives: Drug: Intravitreal injection of methotrexate |
What is being measured
The primary outcome is the main question the study is designed to answer.
Interleukin-10/Interleukin-6（IL-10/IL-6）
aqueous fluid
Measured: 1 year
Interleukin-10/Interleukin-6（IL-10/IL-6）
cerebrospinal
Measured: 2.5 years
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted18 Jul 2023
- Study start1 Oct 2022
- Primary completionDec 2024 (estimated)
- Study completionSep 2025 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Primary Vitreoretinal LymphomaStudies of the same condition, open and under way.
- More trials run by Peking Union Medical College HospitalThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Cohort
- Time perspective
- Prospective
- Enrolment
- 100 participants (estimated)
- Target duration
- 26 Months
Sponsor and investigators
- Lead sponsor
- Peking Union Medical College Hospital
- Sponsor type
- University, hospital or other
- Collaborators
- Beijing Tongren Hospital, Southern Medical University, China
- Responsible party
- Sponsor
- Investigators
- Meifen Zhang, Study chair, Peking Union Medical College Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05950490
- Sponsor's protocol ID
- 2022-PUMCH-C-038
- Status last verified
- Jul 2023
- First submitted
- 11 Jul 2023
- Last updated
- 18 Jul 2023
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 18 Jul 2023. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Construction of Diagnosis and Treatment System for Primary Vitreoretinal Lymphoma
- ClinicalTrials.gov ID
- NCT05950490
- Acronym / sponsor ID
- 2022-PUMCH-C-038
- Conditions
- Primary Vitreoretinal Lymphoma
- Study type
- Observational
- Recruitment status
- Unknown status
- Enrolment
- 100 participants (estimated)
- Lead sponsor
- Peking Union Medical College HospitalUniversity, hospital or other
- Collaborators
- Beijing Tongren Hospital, Southern Medical University, China
- Study start
- 1 Oct 2022 (actual)
- Primary completion
- Dec 2024 (estimated)
- Study completion
- Sep 2025 (estimated)
- First posted
- 18 Jul 2023 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
- Target follow-up
- 26 Months
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Group A | – | Drug: Intravitreal injection of methotrexateCerebrospinal fluid IL-10 was normal |
| Group B | – | Drug: Intravitreal injection of methotrexateCerebrospinal fluid IL-10 was normal or elevated |
Who may qualify
- Ages
- 18 to 75 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
- Study population
- Newly diagnosed PVRL patients admitted to the Ophthalmology or Hematology departments of Peking Union Medical College Hospital from 2022 to 2024.
Key inclusion criteria (6 listed)
- 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;
Key exclusion criteria (4 listed)
- Combined with other tumors;
- Uncontrolled active infections;
- Pregnant or lactating women;
- Antitumor therapy other than the protocol of this study was used.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Intravitreal injection of methotrexateAlso: Intravitreal injection of methotrexate+systemic therapyIntravitreal 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 | Drug | Group A, Group B |
Primary outcome
Interleukin-10/Interleukin-6（IL-10/IL-6）
Time frame: 1 year
aqueous fluid
Interleukin-10/Interleukin-6（IL-10/IL-6）
Time frame: 2.5 years
cerebrospinal
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 18 Jul 2023.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Meifen Zhang study chair
Peking Union Medical College Hospital
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Primary Vitreoretinal Lymphoma, run by Peking Union Medical College Hospital at 1 site in China.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 6 inclusion and 4 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: status not confirmed, as of the sponsor's last update on 18 Jul 2023. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in China. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Yujing Qian (+86 15901597377, qianyujing777@126.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Interleukin-10/Interleukin-6（IL-10/IL-6） (time frame: 1 year). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 18 Jul 2023.