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Phase II Trial of ZR-MTX for PIOL

A prospective, phase II clinical trial using the combination of Zanubrutinib, Rituximab and high-dose intravenous methotrexate with intravitreal methotrexate injection therapy for the treatment of primary intraocular lymphoma

Status
Recruiting
Phases
Phase 2
Study type
Interventional
Source
ChiCTR
Registry ID
ChiCTR2500104446
Enrollment
Unknown
Registered
2025-06-17
Start date
2024-10-10
Completion date
Unknown
Last updated
2025-06-24

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

primary intraocular lymphoma

Interventions

ZR-MTX:Rituximab,zanubrutinib, methotrexate

Sponsors

Peking Union Medical College Hospital
Lead Sponsor

Eligibility

Sex/Gender
All
Age
18 Years to 75 Years

Inclusion criteria

Inclusion criteria: 1.Patients with treatment-naïve primary intraocular lymphoma who are pathologically confirmed or meet the criteria for the diagnosis of intraocular lymphoma; 2.Age 18-75 years old; 3.Physical Fitness Score (ECOG) = 1.0×10^9/L, PLT>50×10^9/L); 6.Creatinine clearance = 30 ml/min (calculated by Cockcroft-Gault formula); 7.Liver function tests: total bilirubin = 2.0 times the upper limit of normal, ALT <= 3 times the upper normal limit; 8.Patients of childbearing potential must guarantee strict, highly effective contraception for the duration of the study.

Exclusion criteria

Exclusion criteria: 1.Patients with primary intraocular lymphoma involving the intracranial region; 2.Patients with ocular involvement of systemic lymphoma; 3.Uncontrolled active infections; 4.Organic heart disease accompanied by obvious clinical symptoms, such as uncontrolled arrhythmia, uncontrolled heart failure, uncontrolled hypertension, etc., can be classified according to the New York Heart Association (NYHA) grading system; 5.Strong CYP3A inducers or inhibitors should be taken simultaneously; 6.Need to use anticoagulant drugs simultaneously; 7.Known to have human immunodeficiency virus (HIV) infection, or serological tests showing active hepatitis B or C virus infection (HBsAg positive or HCV-RNA positive); 8.Subjects who are known or suspected to be unable to comply with the research protocol Pregnant or lactating women.

Design outcomes

Primary

MeasureTime frame
Progression free survival;

Secondary

MeasureTime frame
Overall reponse rate and complete remission rate during induction therapy;Overall survival;Safery;

Countries

China

Contacts

Public ContactWei Zhang

Peking Union Medical College Hospital

vv1223@vip.sina.com+86 10 69155200

Outcome results

None listed

Source: ChiCTR (via WHO ICTRP) · Data processed: Feb 4, 2026