Join us at Health Research Day — June 6th at Canton Waterfront Park, Baltimore!   Learn More →
← Back to all trials
Recruiting NCT06973811

ZR-MTX for PIOL Phase II Trial

Conditions: Primary Intraocular Lymphoma

Sex: All
Ages: 18 Years – 75 Years
Healthy volunteers: No
Phase: PHASE2
Enrollment: 47
Sponsor: Peking Union Medical College Hospital

Location: Peking Union Medical College Hospital Beijing Beijing Municipality

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).

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

Interested in this study? View the official listing for contact and enrollment details.

View on ClinicalTrials.gov

Source: ClinicalTrials.gov (NCT06973811). StuddyBuddy aggregates publicly available trial information.