Clinical trial · Interventional
Intravitreal Methotrexate and R2(Rituximab & Lenalidomide) Regimen in Newly-diagnosed Primary Vitreoretinal Lymphoma
Combined Intravitreal Methotrexate and R2 Regimen Followed by Lenalidomide Maintenance in Newly-diagnosed Primary Vitreoretinal Lymphoma
NCT03746223CI-TRIAL-00041070unknownPhase 2ClinicalTrials.gov clinicaltrialsProvenance
- Source
- ClinicalTrials.gov
- Retrieved
- Sep 8, 2026
- Layer
- normalized (units and labels harmonized; values unchanged)
- Run
- ING-CLINICALTRIALS-20260908-000001
Summary
Brief summary (as posted)
This is a prospective single arm phase II study, and the purpose of this study is to evaluate the efficiency of R2 regimen (rituximab \& lenalidomide) combined with intravitreal methotrexate and followed by lenalidomide maintenance in newly-diagnosed primary intraocular lymphoma. Progression free survival (PFS) of the cohort is the primary endpoint.
Conditions
Conditions (1)
Free-text conditions as registered, with the CancerIndex entity they were reconciled to and the match type.
| Condition (as posted) | Mapped entity | Match | Confidence |
|---|---|---|---|
| Primary Intraocular Lymphoma | Primary Intraocular Non-Hodgkin Lymphoma | ALIAS | 0.90 |
Interventions
Interventions (3)
| Intervention | Type | Mapped drug | Match |
|---|---|---|---|
| Lenalidomide | Drug | Lenalidomide | ALIAS |
| Methotrexate | Drug | Methotrexate | ALIAS |
| Rituximab | Drug | Rituximab | ALIAS |
Design
Arms and outcomes
Arms (1)
- type
- EXPERIMENTAL
- label
- R2-R/IV-MTX（methotrexate）
- description
- experimental arm will be treated rituximab plus lenalidomide (R2) regimen for 6 cycles and followed by lenalidomide maintenance for 2 years, meanwhile intravitreal methotrexate will be given as protocol
- interventionNames
- Drug: Methotrexate
- Drug: Rituximab
- Drug: Lenalidomide
Primary outcomes (1)
- measure
- 2 years progression-free survival
- timeFrame
- from the date of treatment to the subject finished his 2 years follow-up phase or the disease relapsed or the death due to lymphoma
- description
- 2 years progression-free survival was calculated from the date of therapy until death from lymphoma or 2-year follow-up without relapsing
Secondary outcomes (1)
- measure
Eligibility
Eligibility (as posted)
- Sex
- All
- Minimum age
- 18 Years
- Maximum age
- 75 Years
Show eligibility criteria text
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
References
Publications (1)
- DERIVEDZhang Y, Zhang X, Zou D, Yin J, Zhang L, Wang X, Jia C, Wang W, Zhao D, Zhou D, Zhang W, Zhang M. Lenalidomide and Rituximab Regimen Combined With Intravitreal Methotrexate Followed by Lenalidomide Maintenance for Primary Vitreoretinal Lymphoma: A Prospective Phase II Study. Front Oncol. 2021 Jun 24;11:701507. doi: 10.3389/fonc.2021.701507. eCollection 2021. PMID 34249763