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

H. Lee Moffitt Cancer Center and Research Institute

Status and phase: Enrolling; Phase 2

Conditions: Large B-cell Lymphoma

Treatments: Drug: Tafasitamab; Drug: Lenalidomide

Study type: Interventional

Funder types: Other; Industry

Identifiers

NCT06760156

MCC-21955

Details and patient eligibility

About

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.

Enrollment: 28 estimated patients

Sex: All

Ages: 18+ years old

Volunteers: No Healthy Volunteers

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.

Trial design

Primary purpose: Treatment

Allocation: N/A

Interventional model: Single Group Assignment

Masking: None (Open label)

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28 participants in 1 patient group

Tafasitamab and Lenalidomide Treatment

Experimental group

Description:

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.

Treatment:

Drug: Lenalidomide

Drug: Tafasitamab