Overview

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