Status:
UNKNOWN
R2-MTX With Lenalidomide Maintenance in Newly-diagnosed PCNSL：a Multicenter Phase Ib/II Stuty
Lead Sponsor:
Peking Union Medical College Hospital
Collaborating Sponsors:
Beijing Tiantan Hospital
Xuanwu Hospital, Beijing
Conditions:
Primary Central Nervous System Lymphoma
Eligibility:
All Genders
18-75 years
Phase:
PHASE1
PHASE2
Brief Summary
This is a multicenter prospective single arm phase Ib/II study, and the purpose of this study is to evaluate the safety and efficiency of R2-MTX regimen (rituximab \& lenalidomide \& methotrexate) com...
Detailed Description
There are 2 section of this trial. Step1 is a phase Ib study.The patients will be treated with R2-MTX regimen （Rituximab 375mg/m2 IV d0, methotrexate 3.5g/m2 civ d1, lenalidomide 15-25mg d1-14, 21 day...
Eligibility Criteria
Inclusion
- Newly-diagnosed primary vitreoretinal lymphoma
- ECOG≤2
- creatinine clearance rate (CCR) ≥ 50ml/h, according to Cockcroft-Gault
- Total bilirubin \< 2 upper limits of normal, alanine aminotransferase（ALT） \< 3 upper limits of normal
- HIV-Ab negative
- 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
- Pre-existing uncontrolled active infection
- Clinical evidence of grade 3 or 4 heart failure as defined by the New York Heart Association criteria
- systemic lymphoma involved CNS
- Pregnancy or active lactation
- Co-existing tumors
Key Trial Info
Start Date :
August 16 2019
Trial Type :
INTERVENTIONAL
Allocation :
ESTIMATED
End Date :
August 1 2024
Estimated Enrollment :
47 Patients enrolled
Trial Details
Trial ID
NCT04120350
Start Date
August 16 2019
End Date
August 1 2024
Last Update
June 5 2020
Active Locations (1)
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1
Daobin Zhou
Beijing, Dongcheng District, China, 100730