R2-MTX With Lenalidomide Maintenance in Newly-diagnosed PCNSL：a Multicenter Phase Ib/II Stuty

• Status: Recruiting
• Trial end date: 2024-08-01
• Target enrollment: 0
• Participant gender: All

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) combined with lenalidomide maintenance in newly-diagnosed primary central nervous system lymphoma. 2-year Progression free survival (PFS) of the cohort is the primary endpoint.

• Phase: Phase 1/Phase 2
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: Peking Union Medical College Hospital
• Collaborators: Beijing Hospital; Beijing Tiantan Hospital; Chinese PLA General Hospital; Peking University First Hospital; Peking University Third Hospital; Xuanwu Hospital, Beijing
• Treatments: Lenalidomide; Methotrexate; Rituximab

Criteria

Inclusion Criteria:

• 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 Criteria:

• 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