ZR-MTX for PIOL Phase II Trial

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

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

Conditions2

Interventions4

Related trials

• A Phase Ib Clinical Trial of Peguricase for Injection With Methotrexate in Patients With Uncontrolled Gout. — Shanghai Institute Of Biological Products
• Adult Acute Lymphoblastic Leukemia Treated With Pediatric Regimen in Brazil — Instituto do Cancer do Estado de São Paulo
• Anti-CD25 Monoclonal Antibody for Prevention of Acute GVHD After Haploidentical HSCT — Union Hospital, Tongji Medical College, Huazhong University of Science and Technology
• Blinatumomab Plus Venetoclax Sequenced With Inotuzumab Ozogamicin in Treating B-ALL — First Affiliated Hospital of Zhejiang University
• Card14gene (rs34367357 ) Polymorphism in Egyptian Psoriatic and Psoriatic Arthritis Patient — South Valley University
• Comparing Post-Transplant Cyclophosphamide As GVHD Prophylaxis to Standard of Care for Acute Leukemia Patients — King Faisal Specialist Hospital & Research Center
• Complementary Herbal Approach to Rheumatoid Management Study (CHARMS) — Singapore General Hospital
• Efficacy and Safety of Low-dose Chemotherapy Plus Immuno-targeted Drugs in Newly Diagnosed Adult Ph- B-ALL — Institute of Hematology & Blood Diseases Hospital, China

Browse More Trials