ZR-MTX for PIOL Phase II Trial
ConditionPrimary Intraocular Lymphoma
Trial statusRecruiting
Trial phasePhase 2
Trial typeInterventional
Biological sexAll
Age18-75
SponsorPeking Union Medical College Hospital
About this trial
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 criteria
Qualifiers
• 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
Disqualifiers
• 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
Trial design
Treatments tested in this trial
- Methotrexate
- Rituximab (R)
- Zanubrutinib
- Methotrexate (MTX)
Treatment groups
47 Participants
are divided into 1 treatment groupSponsors and collaborators
Source ClinicalTrials.gov