Tafasitamab and Lenalidomide as First Salvage Therapy for Residual Large B Cell Lym

{ "Tafasitamab and Lenalidomide for Large B-cell Lymphoma", "This study is looking at how safe and effective a combination of two drugs, tafasitamab and lenalidomide, is for people with Large B-cell Lymphoma (LBCL). This treatment is for those who have already received a specific type of CAR T-cell therapy called axicabtagene ciloleucel (axi-cel). The study aims to see how many participants achieve a complete response (meaning all signs of cancer disappear) within three months. You may be able to join if you are 18 years or older and have a confirmed diagnosis of Large B-cell Lymphoma. The study plans to enroll 28 participants, but its current recruitment status is unclear.", "design": "This is an interventional study, meaning participants will receive a specific treatment. It plans to enroll 28 participants.", "commitments": "Participants will be asked to spend about 12 months in this study.", "compensation": "Not stated in the trial record.", "follow_up": "The primary goal is measured up to 3 months, but participants will be in the study for about 12 months.", }

Study design: Not specified.
What's involved: Not specified in the trial record.
Compensation: Not stated in the trial record.
Follow-up: Not specified.

AI-generated from the public study record. Only the study team can confirm whether you're eligible — confirm details with them before making decisions.

Tafasitamab and Lenalidomide as First Salvage Therapy for Residual Large B Cell Lym

Recruiting

PHASE2Ages 18+InterventionalTreatment

H. Lee Moffitt Cancer Center and Research Institute

~28 participants

Updated 2026-04-03 on ClinicalTrials.gov

What's tested:TafasitamabLenalidomide

At a glance

Recruiting sites

1 of 1 listed site is recruiting right now

RecruitingSuspended, closed, or not yet open

What they're measuring

Complete Response Rate (CRR)

Measured over Up to 3 months

Conditions

Large B-cell Lymphoma

Where it's being run

1 sites across 1 states

Florida1

Study leadership

Frederick Locke, MD · PRINCIPAL_INVESTIGATOR · Moffitt Cancer Center

Who to contact

Kim Sprenger

[email protected]

813-745-0330

Email the study team

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Do you actually qualify for this trial?

Add a private profile and we'll compare every criterion below against your situation — and tell you which ones are met, uncertain, or excluding.

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Eligibility criteria

Inclusion

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

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.

What this trial measures

Complete Response Rate (CRR)Up to 3 months
Complete Response Rate (CRR) is defined as the proportion of patients with a Complete Response (CR)

Trialytics