Intravitreal MTX and ZR Regimen in Newly Diagnosed PVRL

• Status: Recruiting
• Trial end date: 2024-08-01
• 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 ZR regimen (rituximab & Zanubrutinib) combined with intravitreal methotrexate and followed by Zanubrutinib 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: Methotrexate; Rituximab; Zanubrutinib

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 or HBV or HCV