The purpose of the study is to evaluate the safety and efficacy of tafasitamab and lenalidomide in participants with Large B Cell Lymphoma (LBCL) after axicabtagene ciloleucel (axi-cel) treatment. Participants will be asked to spend about 12 months in this study.
Patients must have histologically documented history of large B-cell lymphoma, including diffuse large B-cell lymphoma (DLBCL) not otherwise specified, primary mediastinal large B-cell lymphoma, high grade B-cell lymphoma, and DLBCL arising from follicular lymphoma.
Adult males or females must be of age ≥18 years or older at time of signing informed consent.
Patients must be capable of understanding the protocol with willingness to comply with all study procedures including availability for the duration of the study.
Patients must be able to understand and willing to sign a written informed consent form (ICF) document.
Patients who are currently receiving or who have received any investigational study agent ≤4 weeks prior to the screening visit are ineligible.
Detectable cerebrospinal fluid malignant cells, brain metastases, or active central nervous system (CNS) lymphoma after CAR T cell administration.
History or presence of CNS disorder, such as seizure disorder, cerebrovascular ischemia/hemorrhage, dementia, cerebellar disease, or any autoimmune disease with CNS involvement.
Presence of bacterial, viral, fungal, and/or other infection of any origin that is uncontrolled and/or requires intravenous (IV) antimicrobials for treatment.
Single group
Tafasitamab
DrugThe recommended dose of tafasitamab is 12 mg/kg.
Lenalidomide
DrugThe starting dose for lenalidomide will be 25 mg PO daily.
Complete Response Rate (CRR)
Complete Response Rate (CRR) is defined as the proportion of patients with a Complete Response (CR)
Objectives Response Rate (ORR)
Defined as the incidence of either a complete response (CR) or a partial response (PR) per Lugano Classification as determined by study investigators.
Duration of Response (DoR)
DoR is defined as the date of their first objective response to disease progression per Lugano Classification as determined by study investigators or death from any cause.
Progression Free Survival (PFS)
Defined as the time from tafasitamab infusion date to the date of disease progression per Lugano Classification as determined by study investigators or death from any cause.
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H. Lee Moffitt Cancer Center and Research Institute
Lead sponsor
Incyte Corporation
Collaborator
