tafasitamab and lenalidomide as first salvage therapy for residual large b cell lym

Conditions: Large B-cell Lymphoma

Summary: 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.


Eligibility criteria:
inclusion criteria: * 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. * measurable pet/ct positive disease (partial response or stable disease per the 2014 lugano classification) on pet/ct obtained at least 21 days after, but no more than 60 days after car-t with axicabtagene-ciloleucel. * eastern cooperative oncology group (ecog) performance status 0-2. * participants must have adequate organ and bone marrow function. * patients must have adequate hepatic function. * patients must have adequate renal function. * baseline oxygen saturation \>92% on room air. * females of reproductive potential must avoid pregnancy for at least 4 weeks before beginning lenalidomide therapy, during therapy, during dose interruptions and for at least 4 weeks after completing therapy. females must commit either to abstain continuously from heterosexual sexual intercourse or to use two methods of reliable birth control, beginning 4 weeks prior to initiating treatment with lenalidomide, during therapy, during dose interruptions and continuing for 4 weeks following discontinuation of lenalidomide therapy. exclusion criteria: * 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. * known cardiac atrial or cardiac ventricular lymphoma involvement. * history of symptomatic pulmonary embolism within 6 months of enrollment. * known primary immunodeficiency. * history of autoimmune disease (e.g. crohn's disease, rheumatoid arthritis, systemic lupus) resulting in end organ injury or requiring systemic immunosuppression/systemic disease modifying agents within the last 2 years. * history of hypersensitivity, allergy or severe skin reactions to lenalidomide (e.g., angioedema, stevens-johnson syndrome, toxic epidermal necrolysis). * history of hypersensitivity, allergy or previous exposure to tafasitamab. * any medical condition deemed by the treating physician likely to interfere with assessment of safety or efficacy of study treatment.