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

Last updated: December 2, 2025
Sponsor: H. Lee Moffitt Cancer Center and Research Institute
Overall Status: Active - Recruiting

Phase

2

Condition

Lymphoma, B-cell

Lymphoma

Treatment

Lenalidomide

Tafasitamab

Clinical Study ID

NCT06760156
MCC-21955
  • Ages > 18
  • All Genders

Study 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

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

Total Participants: 28
Treatment Group(s): 2
Primary Treatment: Lenalidomide
Phase: 2
Study Start date:
March 19, 2025
Estimated Completion Date:
January 31, 2028

Connect with a study center

  • Moffitt Cancer Center

    Tampa, Florida 33612
    United States

    Site Not Available

  • Moffitt Cancer Center

    Tampa 4174757, Florida 4155751 33612
    United States

    Active - Recruiting

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