Investigation of Tafasitamab and Lenalidomide Treatment in Adults with Relapsed CNS Lymphoma

What this Trial Is About

Researchers are investigating the combination of Tafasitamab and Lenalidomide in patients with relapsed central nervous system CNS lymphoma, focusing on those with relapsed primary or secondary CNS lymphoma of diffuse large B-cell lymphoma type. This phase III, single-arm, open-label, multicenter study aims to determine the maximum tolerated dose and recommended phase 2 dose of Lenalidomide combined with Tafasitamab, a novel anti-CD19 monoclonal antibody. The study also explores whether Tafasitamab can improve blood-brain barrier permeability, which could have important implications for treatment delivery. Participants receive Tafasitamab intravenously at 12 mgkg on specific days of each treatment cycle and Lenalidomide orally daily on days 1-21 of each cycle. The phase 1 portion tests three Lenalidomide dose levels 10mg, 15mg, and 20mg combined with Tafasitamab, while the phase 2 portion enrolls participants at the recommended dose determined from phase 1. Treatment continues until disease progression, with follow-up for adverse events and survival. Throughout the study, participants undergo evaluations including monitoring for dose-limiting toxicities, clinical benefit rates, and treatment-related adverse events. Researchers also assess progression-free and overall survival up to one year after treatment. Additional exploratory tests include measuring drug penetration into cerebrospinal fluid, immune cell changes, cytokine profiles, tumor mutation analysis, blood-brain barrier permeability, and minimal residual disease status. Participants are followed for adverse events 90 days post-treatment and for survival status for up to one year.

Tafasitamab Plus Lenalidomide in Relapsed CNS Lymphoma