Using Tafasitamab and Lenalidomide for Large B-cell Lymphoma after CAR-T Therapy

Is this trial a fit for you?

A plain-English reading of the study's rules. Only the study team can confirm whether you qualify.

What this trial studies

This study evaluates the safety and efficacy of tafasitamab and lenalidomide as first salvage therapy in patients with Large B-cell Lymphoma (LBCL) who have residual disease following treatment with axicabtagene ciloleucel (axi-cel). Participants will undergo treatment for approximately 12 months, with assessments to monitor their response to the therapy. The study aims to provide insights into the effectiveness of these medications in managing LBCL after CAR-T therapy.

Why it matters

Who can join: the full rules

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.

Where it's running

• Moffitt Cancer Center
  Tampa, Florida, United States Recruiting

Study contacts

• Principal investigator: Frederick Locke, MD — Moffitt Cancer Center
• Study coordinator: Kim Sprenger
• Email: ICETtrials@moffitt.org
• Phone: 813-745-0330

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Other studies for the same condition or treatment. Recruiting studies are listed first.

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How to take part

1. Review the eligibility criteria above with your treating physician.
2. Check the official listing on ClinicalTrials.gov for the latest contact details and recruitment status.
3. Contact the study coordinator or principal investigator to ask for pre-screening. Pre-screening is free and never obligates you to enroll.