Treatment for newly-diagnosed primary vitreoretinal lymphoma using a combination of medications
Combined Intravitreal Methotrexate and R2 Regimen Followed by Lenalidomide Maintenance in Newly-diagnosed Primary Vitreoretinal Lymphoma
This study is testing a new combination of medications to see if it can help people who have just been diagnosed with primary vitreoretinal lymphoma live longer without their disease getting worse.
Quick facts
| Phase | Phase 2 |
|---|---|
| Study type | Interventional |
| Enrollment | 42 (estimated) |
| Ages | 18 Years to 75 Years |
| Sex | All |
| Sponsor | Peking Union Medical College Hospital Academic / other |
| Drugs / interventions | rituximab, methotrexate |
| Locations | 1 site (Beijing, Beijing) |
| Trial ID | NCT03746223 on ClinicalTrials.gov |
What this trial studies
This phase II clinical trial evaluates the effectiveness of a treatment regimen combining rituximab and lenalidomide with intravitreal methotrexate for patients newly diagnosed with primary intraocular lymphoma. Participants will receive the R2 regimen as an induction treatment, followed by maintenance therapy for those who achieve remission. The study aims to assess progression-free survival as the primary endpoint, with regular evaluations every three cycles. Patients will be monitored through ophthalmologic examinations and MRI scans during the follow-up period.
Who should consider this trial
Good fit: Ideal candidates are individuals newly diagnosed with primary vitreoretinal lymphoma who meet specific health criteria.
Not a fit: Patients with primary central nervous system lymphoma or those with systemic B cell lymphoma involving the eyes may not benefit from this study.
Why it matters
Potential benefit: If successful, this treatment could significantly improve outcomes for patients with primary vitreoretinal lymphoma.
How similar studies have performed: While this approach is innovative, similar studies have shown promise in treating other forms of lymphoma with combined therapies.
Eligibility criteria
Show full inclusion / exclusion criteria
Inclusion Criteria: * Newly-diagnosed primary vitreoretinal lymphoma * ECOG≤2 * creatinine clearance rate (CCR) ≥ 60ml/h, according to Cockcroft-Gault * Total bilirubin \< 2 upper limits of normal, alanine aminotransferase（ALT） \< 3 upper limits of normal * Sign the Informed consent * Women of childbearing potential must understand that the study medication could have a potential teratogenic risk. They should undergo complete contraception during the study period. * Male subjects must agree to use condoms throughout study drug therapy. Exclusion Criteria: * primary central nervous system lymphoma involved eyes and brain * systemic B cell lymphoma involved eyes * Pre-existing uncontrolled active infection * Clinical evidence of grade 3 or 4 heart failure as defined by the New York Heart Association criteria * Pregnancy or active lactation * Co-existing tumors * HIV（human immunodeficiency virus） or HBV（hepatitis B virus） or HCV（hepatitis C virus） infection
Where this trial is running
Beijing, Beijing
- Peking Union medical college hospital — Beijing, Beijing, China (Recruiting)
Study contacts
- Principal investigator: Daobin Zhou, MD — Peking Union Medical College Hospital
- Study coordinator: Wei Zhang, MD
- Email: vv1223@vip.sina.com
- Phone: +86 136 8147 3557
How to participate
- Review the eligibility criteria above with your treating physician.
- Visit the official trial page on ClinicalTrials.gov for the most current contact information and recruitment status.
- Contact the listed study coordinator or principal investigator to request pre-screening. Pre-screening is free and never obligates you to enroll.