Methotrexate: 400ug intravitreal injection every week for 4 doses in the induction phase, every 2 weeks for 2 doses as consolidation, then every month for 10 doses
Rituximab (R): Rituximab 375mg/m2 intravenous infusion d1, every 21 days for 1 cycle. 6 cycles will be prescribed as protocol
Zanubrutinib: 160mg Bid, oral. 21-day cycle for 6 cycles in the induction phase and for 2 years in the maintenance phase
Methotrexate (MTX): Methotrexate 3.5g/m2 intravenous infusion d1, every 21 days for cycle 5 and 6 only.
Study summary
This is a prospective single-arm phase II study, with the purpose of evaluating the efficiency of ZR-MTX regimen (Rituximab, Zanubrutinib and methotrexate) combined with intravitreal methotrexate, then followed by minimal residual disease directed Zanubrutinib maintenance in newly-diagnosed primary intraocular lymphoma. The primary endpoint of this study is progression-free survival (PFS).
Eligibility
Sex
ALL
Min age
18 Years
Max age
75 Years
Healthy volunteers
No
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 infection
Primary outcome measure(s)
2 years progression-free survival — 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 2 years progression-free survival was calculated from the date of therapy until death from lymphoma or 2-year follow up without relapsing
This page summarises publicly available registry data for informational purposes — not medical advice. Eligibility is determined by each study team; patients should discuss participation with their clinician.
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