Status:
NOT_YET_RECRUITING
ZR-MTX for PIOL Phase II Trial
Lead Sponsor:
Peking Union Medical College Hospital
Conditions:
Primary Intraocular Lymphoma
Eligibility:
All Genders
18-75 years
Phase:
PHASE2
Brief 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, the...
Detailed Description
All the patients will be treated with ZR regimen (Rituximab 375mg/m2 IV d1, Zanubrutinib 160mg Bid, 21 days per cycle) as induction regimen. The response will be evaluated after 2 cycles of ZR regimen...
Eligibility Criteria
Inclusion
- • 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
- • 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
Key Trial Info
Start Date :
May 10 2025
Trial Type :
INTERVENTIONAL
Allocation :
ESTIMATED
End Date :
October 30 2029
Estimated Enrollment :
47 Patients enrolled
Trial Details
Trial ID
NCT06973811
Start Date
May 10 2025
End Date
October 30 2029
Last Update
May 20 2025
Active Locations (1)
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1
Peking Union Medical College Hospital
Beijing, Beijing Municipality, China