Intravitreal Methotrexate and R2(Rituximab & Lenalidomide) Regimen in Newly-diagnosed Primary Vitreoretinal Lymphoma

• Status: Recruiting
• Trial end date: 2025-10-15
• Target enrollment: 0
• Participant gender: All

Summary

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.

• Phase: Phase 2
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: Peking Union Medical College Hospital
• Treatments: Lenalidomide; Methotrexate; Rituximab; Thalidomide

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