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ZR-MTX for PIOL Phase II Trial
Sponsor: Peking Union Medical College Hospital
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).
Official title: A Prospective, Phase II Clinical Trial Using the Combination of Zanubrutinib, Rituximab and High-dose Intravenous Methotrexate With Intravitreal Methotrexate Injection Therapy for the Treatment of Primary Intraocular Lymphoma
Key Details
Gender
All
Age Range
18 Years - 75 Years
Study Type
INTERVENTIONAL
Enrollment
47
Start Date
2025-05-10
Completion Date
2029-10-30
Last Updated
2025-05-20
Healthy Volunteers
No
Conditions
Interventions
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.
Locations (1)
Peking Union Medical College Hospital
Beijing, Beijing Municipality, China