Tafasitamab Plus Lenalidomide in Relapsed CNS Lymphoma
Trial Parameters
Brief Summary
This is a single arm open-label multicenter phase I/II investigation of combination lenalidomide/Tafasitamab in patients with relapsed central nervous system (CNS) lymphoma. This is the first study to examine a naked anti-CD19 monoclonal antibody in relapsed CNS lymphoma patients as well as the combination of anti-CD19 antibody plus an Immunomodulatory imide drugs (IMiDs) in CNS lymphomas. This study will also test the novel hypothesis that Tafasitamab enhances blood-brain barrier permeability, a potential property that could have broad clinical implications.
Eligibility Criteria
Inclusion Criteria: 1. Participants must have relapsed primary or secondary CNS lymphoma, diffuse large B-cell lymphoma (DLBCL) type, based on radiographic, ophthalmologic, or CSF criteria (evidence of malignant cells based on CSF studies: cytospin/cytology and flow-cytometry). 1. Concomitant systemic lymphoma as well as transformation from follicular lymphoma and/or Chronic lymphocytic leukemia (CLL) to an aggressive B-cell histology is allowed. 2. Participants are eligible with disease in each CNS compartment: brain, leptomeninges/CSF and intraocular compartment. 2. Age \>= 18 years. 3. Anticipated survival \> 2 months, as determined by the investigator. 4. Eastern Cooperative Oncology Group (ECOG) performance status \<=1 (Karnofsky performance status \>= 70%) 5. Demonstrates adequate organ function as defined below: 1. Absolute neutrophil count (ANC) ≥ 1.5 X 10\^9/ L (1,500/ microliter (mcL), growth factors permitted). 2. Platelets \>= 50 X 10\^9 / L (50,000/ mcL, platelet transfusi