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

NCT ID: NCT06760156

Last Updated: 2025-12-04

Basic Information

• Recruitment Status: RECRUITING
• Clinical Phase: PHASE2
• Total Enrollment: 28 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2025-03-19
• Study Completion Date: 2028-01-31

Brief 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.

Conditions

Large B-cell Lymphoma

Study Design

• Allocation Method: NA
• Intervention Model: SINGLE_GROUP
• Primary Study Purpose: TREATMENT
• Blinding Strategy: NONE

Study Groups

Tafasitamab and Lenalidomide Treatment

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.

Group Type: EXPERIMENTAL

Tafasitamab

Intervention Type: DRUG

The recommended dose of tafasitamab is 12 mg/kg.

Lenalidomide

Intervention Type: DRUG

The starting dose for lenalidomide will be 25 mg PO daily.

Interventions

Tafasitamab

The recommended dose of tafasitamab is 12 mg/kg.

Intervention Type: DRUG

Lenalidomide

The starting dose for lenalidomide will be 25 mg PO daily.

Intervention Type: DRUG

Eligibility Criteria

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.

• Minimum Eligible Age: 18 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Incyte Corporation

INDUSTRY

Sponsor Role: collaborator

H. Lee Moffitt Cancer Center and Research Institute

OTHER

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Principal Investigators

Frederick Locke, MD

Role: PRINCIPAL_INVESTIGATOR

Moffitt Cancer Center

Locations

Moffitt Cancer Center

Tampa, Florida, United States

Site Status: RECRUITING

Countries

United States

Central Contacts

Kim Sprenger

Role: CONTACT

Kimberly.Sprenger@moffitt.org

813-745-0330

Other Identifiers

MCC-21955

Identifier Type: -

Identifier Source: org_study_id