ZR-MTX combo for newly diagnosed primary intraocular lymphoma

Is this trial a fit for you?

A plain-English reading of the study's rules. Only the study team can confirm whether you qualify.

What this trial studies

This is a single-arm phase II study evaluating the ZR-MTX regimen (Rituximab, Zanubrutinib, and methotrexate) with intravitreal methotrexate in newly diagnosed primary intraocular lymphoma. Patients receive induction cycles of ZR therapy, with response guiding additional cycles, followed by limited Zanubrutinib maintenance if needed. Intravitreal methotrexate is administered concurrently, and MRD status influences duration of systemic therapy, with ongoing monitoring through ophthalmologic exams and brain MRI over several years. The primary endpoint is progression-free survival, with safety and eligibility criteria specified for adults with adequate organ function and controlled infections.

Why it matters

Who can join: the full rules

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

Where it's running

• Peking Union Medical College Hospital
  Beijing, Beijing Municipality, China Recruiting

Study contacts

• Study coordinator: Wei Zhang, M.M.
• Email: vv1223@vip.sina.com
• Phone: 13681473557

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How to take part

1. Review the eligibility criteria above with your treating physician.
2. Check the official listing on ClinicalTrials.gov for the latest contact details and recruitment status.
3. Contact the study coordinator or principal investigator to ask for pre-screening. Pre-screening is free and never obligates you to enroll.