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RECRUITING Phase 2 ClinicalTrials.gov

ZR-MTX for PIOL Phase II Trial

Sponsor: Peking Union Medical College Hospital • ClinicalTrials.gov ID: NCT06973811

Registry updated: 2026-09-04
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Description

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).

Interventions

  • Methotrexate (Drug)
    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) (Drug)
    Rituximab 375mg/m2 intravenous infusion d1, every 21 days for 1 cycle. 6 cycles will be prescribed as protocol
  • Zanubrutinib (Drug)
    160mg Bid, oral. 21-day cycle for 6 cycles in the induction phase and for 2 years in the maintenance phase
  • Methotrexate (MTX) (Drug)
    Methotrexate 3.5g/m2 intravenous infusion d1, every 21 days for cycle 5 and 6 only.

Eligibility 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 infection

Conditions

Primary Intraocular Lymphoma

Locations

  • Peking Union Medical College Hospital — Beijing, Beijing Municipality, China
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Official Source

Data sourced from ClinicalTrials.gov, a service of the U.S. National Institutes of Health.

View Official Record