drugset / Trial / NCT06973811
ZR-MTX for PIOL Phase II Trial
NaSingle-groupOpen-labelTreatment
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).
Timeline
- Start
- 2025-05-10
- Primary completion
- 2027-10-30
- Completion
- 2029-10-30
Drugs
| Evaluation | Drug | Modality | Dose | Route |
|---|---|---|---|---|
| Subject | Methotrexate | Small molecule | 400 ug | Intravitreal |
| Subject | Methotrexate | Small molecule | 3.5 g | Intravitreal |
| Subject | Rituximab | Monoclonal antibody | 375 mg/m2 | Intravenous |
| Subject | Zanubrutinib | Small molecule | 160 mg | Oral |