Primary Intraocular Lymphoma Clinical Trial
Official title:
Combined Intravitreal Methotrexate and R2 Regimen Followed by Lenalidomide Maintenance in Newly-diagnosed Primary Vitreoretinal Lymphoma
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.
All the patients will be treated with R2 regimen （Rituximab 375mg/m2 IV d1, lenalidomide 25mg
d1-21, 28 days per cycle) as induction regimen, meanwhile intravitreal methotrexate was given
at a dose of 400ug for 16 doses.
The response will be evaluated every 3 cycles. After 3 Cycles, patients who achieved complete
remission (CR) or partial remission (PR) will receive 3 more cycles of R2 regimen. The
patients with stable disease (SD) or progressed disease (PD) will withdraw from the trial and
receive salvage regimens. After total 6 induction cycles, the investigators evaluate the
efficiency again, the patients with CR or PR will go to lenalidomide maintenance for 2 years
or until progression of the disease (PD), unacceptable toxicity, or patient/investigator
discretion. And the patients with SD or PD will receive salvage regimen.
During following-up, surveillance ophthalmologic examination and brain magnetic resonance
imaging (MRI) scans can be performed every 3 months up to the first 2 years, followed by
doctor visit every 6 months up to 5 years or the disease relapses.
;