[{"data":1,"prerenderedAt":-1},["ShallowReactive",2],{"health-study-detail:100574505":3},{"organization":4,"armGroups":7,"interventions":15,"overallOfficials":26,"centralContacts":31,"locations":37,"responsibleParty":70,"collaborators":72,"id":76,"slug":77,"hasResults":78,"nctId":79,"briefTitle":80,"officialTitle":81,"acronym":21,"eligibilityCriteria":82,"healthyVolunteers":78,"sex":83,"minAge":84,"maxAge":21,"enrollmentInfo":85,"targetDuration":21,"studyType":88,"phases":89,"briefSummary":91,"conditions":92,"keywords":21,"overallStatus":39,"whyStopped":21,"lastUpdateSubmitDate":94,"lastUpdatePostDateStruct":95,"startDateStruct":98,"completionDateStruct":100,"leadSponsor":102,"locationsCount":103},{"fullName":5,"class":6},"H. Lee Moffitt Cancer Center and Research Institute","OTHER",[8],{"label":9,"type":10,"description":11,"interventionNames":12},"Tafasitamab and Lenalidomide Treatment","EXPERIMENTAL","Participants will receive the study drug, Tafasitamab, intravenously on a weekly basis for the first three 28-day cycles (Cycles 1-3) and then every 2 weeks starting at Cycle 4 onwards. Participants will take the study drug, Lenalidomide, once daily for 21 days out of each 28-day cycle for 6 cycles.",[13,14],"Drug: Tafasitamab","Drug: Lenalidomide",[16,22],{"type":17,"name":18,"description":19,"armGroupLabels":20,"otherNames":21},"DRUG","Tafasitamab","The recommended dose of tafasitamab is 12 mg\u002Fkg.",[9],null,{"type":17,"name":23,"description":24,"armGroupLabels":25,"otherNames":21},"Lenalidomide","The starting dose for lenalidomide will be 25 mg PO daily.",[9],[27],{"name":28,"affiliation":29,"role":30},"Frederick Locke, MD","Moffitt Cancer Center","PRINCIPAL_INVESTIGATOR",[32],{"name":33,"role":34,"phone":35,"phoneExt":21,"email":36},"Kim Sprenger","CONTACT","813-745-0330","ICETtrials@moffitt.org",[38],{"facility":29,"status":39,"city":40,"state":41,"zip":42,"country":43,"countryCode":44,"cosmosGeoPoint":45,"geoPoint":50,"contacts":51},"RECRUITING","Tampa","Florida","33612","United States","US",{"type":46,"coordinates":47},"Point",[48,49],-82.45843,27.94752,{"lat":49,"lon":48},[52,53,56,58,60,62,64,66,68],{"name":28,"role":30,"phone":21,"phoneExt":21,"email":21},{"name":54,"role":55,"phone":21,"phoneExt":21,"email":21},"Julio Chavez, MD","SUB_INVESTIGATOR",{"name":57,"role":55,"phone":21,"phoneExt":21,"email":21},"Sameh Gaballa, MD",{"name":59,"role":55,"phone":21,"phoneExt":21,"email":21},"Michael Jain, MD, PhD",{"name":61,"role":55,"phone":21,"phoneExt":21,"email":21},"Farhad Khimani, MD",{"name":63,"role":55,"phone":21,"phoneExt":21,"email":21},"Aleksandr Lazaryan, MD, PhD",{"name":65,"role":55,"phone":21,"phoneExt":21,"email":21},"Sayeef Mirza, MD",{"name":67,"role":55,"phone":21,"phoneExt":21,"email":21},"Taiga Nishihori, MD",{"name":69,"role":55,"phone":21,"phoneExt":21,"email":21},"Bijal Shah, MD",{"type":71,"investigatorFullName":21,"investigatorTitle":21,"investigatorAffiliation":21,"oldNameTitle":21,"oldOrganization":21},"SPONSOR",[73],{"name":74,"class":75},"Incyte Corporation","INDUSTRY","100574505","phase-2-tafasitamab-and-lenalidomide-as-first-salvage-therapy-for-residual-large-b-cell-lym-100574505",false,"NCT06760156","Tafasitamab and Lenalidomide as First Salvage Therapy for Residual Large B Cell Lym","Phase 2 Study of Tafasitamab and Lenalidomide as First Salvage Therapy for Residual Large B Cell Lymphoma After Axicabtagene Ciloleucel","Inclusion Criteria:\n\n* 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.\n* Adult males or females must be of age ≥18 years or older at time of signing informed consent.\n* Patients must be capable of understanding the protocol with willingness to comply with all study procedures including availability for the duration of the study.\n* Patients must be able to understand and willing to sign a written informed consent form (ICF) document.\n* Measurable PET\u002FCT positive disease (partial response or stable disease per the 2014 Lugano Classification) on PET\u002FCT obtained at least 21 days after, but no more than 60 days after CAR-T with axicabtagene-ciloleucel.\n* Eastern Cooperative Oncology Group (ECOG) performance status 0-2.\n* Participants must have adequate organ and bone marrow function.\n* Patients must have adequate hepatic function.\n* Patients must have adequate renal function.\n* Baseline Oxygen Saturation \\>92% on room air.\n* 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.\n\nExclusion Criteria:\n\n* Patients who are currently receiving or who have received any investigational study agent ≤4 weeks prior to the screening visit are ineligible.\n* Detectable cerebrospinal fluid malignant cells, brain metastases, or active central nervous system (CNS) lymphoma after CAR T cell administration.\n* History or presence of CNS disorder, such as seizure disorder, cerebrovascular ischemia\u002Fhemorrhage, dementia, cerebellar disease, or any autoimmune disease with CNS involvement.\n* Presence of bacterial, viral, fungal, and\u002For other infection of any origin that is uncontrolled and\u002For requires intravenous (IV) antimicrobials for treatment.\n* Known cardiac atrial or cardiac ventricular lymphoma involvement.\n* History of symptomatic pulmonary embolism within 6 months of enrollment.\n* Known primary immunodeficiency.\n* History of autoimmune disease (e.g. Crohn's disease, rheumatoid arthritis, systemic lupus) resulting in end organ injury or requiring systemic immunosuppression\u002Fsystemic disease modifying agents within the last 2 years.\n* History of hypersensitivity, allergy or severe skin reactions to lenalidomide (e.g., angioedema, Stevens-Johnson syndrome, toxic epidermal necrolysis).\n* History of hypersensitivity, allergy or previous exposure to tafasitamab.\n* Any medical condition deemed by the treating physician likely to interfere with assessment of safety or efficacy of study treatment.","ALL","18 Years",{"count":86,"type":87},28,"ESTIMATED","INTERVENTIONAL",[90],"PHASE2","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.",[93],"Large B-cell Lymphoma","2026-03-30",{"date":96,"type":97},"2026-04-03","ACTUAL",{"date":99,"type":97},"2025-03-19",{"date":101,"type":87},"2028-01",{"name":5,"class":6},1]