Phase
Condition
Lymphoma, B-cell
Lymphoma
Treatment
Lenalidomide
Tafasitamab
Clinical Study ID
Ages > 18 All Genders
Study Summary
Eligibility Criteria
Inclusion
Inclusion Criteria:
Patients must have histologically documented history of large B-cell lymphoma,including diffuse large B-cell lymphoma (DLBCL) not otherwise specified, primarymediastinal large B-cell lymphoma, high grade B-cell lymphoma, and DLBCL arisingfrom follicular lymphoma.
Adult males or females must be of age ≥18 years or older at time of signing informedconsent.
Patients must be capable of understanding the protocol with willingness to complywith all study procedures including availability for the duration of the study.
Patients must be able to understand and willing to sign a written informed consentform (ICF) document.
Measurable PET/CT positive disease (partial response or stable disease per the 2014Lugano 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 beforebeginning lenalidomide therapy, during therapy, during dose interruptions and for atleast 4 weeks after completing therapy. Females must commit either to abstaincontinuously from heterosexual sexual intercourse or to use two methods of reliablebirth control, beginning 4 weeks prior to initiating treatment with lenalidomide,during therapy, during dose interruptions and continuing for 4 weeks followingdiscontinuation of lenalidomide therapy.
Exclusion
Exclusion Criteria:
Patients who are currently receiving or who have received any investigational studyagent ≤4 weeks prior to the screening visit are ineligible.
Detectable cerebrospinal fluid malignant cells, brain metastases, or active centralnervous system (CNS) lymphoma after CAR T cell administration.
History or presence of CNS disorder, such as seizure disorder, cerebrovascularischemia/hemorrhage, dementia, cerebellar disease, or any autoimmune disease withCNS involvement.
Presence of bacterial, viral, fungal, and/or other infection of any origin that isuncontrolled 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, systemiclupus) resulting in end organ injury or requiring systemicimmunosuppression/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 withassessment of safety or efficacy of study treatment.
Study Design
Connect with a study center
Moffitt Cancer Center
Tampa, Florida 33612
United StatesSite Not Available
Moffitt Cancer Center
Tampa 4174757, Florida 4155751 33612
United StatesActive - Recruiting

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