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

NCT06760156 | Recruiting Phase 2 DMC FDA Drug

• 1 other identifier: MCC-21955
• Study Type: interventional
• Target: 28
• Locations: 1 country
• Sites: 1

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

Outcome Measures

Primary Outcomes (1)

• Complete Response Rate (CRR)

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

  Up to 3 months

Secondary Outcomes (3)

• Objectives Response Rate (ORR)

  Up to 12 months

• Duration of Response (DoR)

  Up to 12 months

• Progression Free Survival (PFS)

  Up to 12 months

Study Arms (1)

Tafasitamab and Lenalidomide Treatment

EXPERIMENTAL

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.

Drug: Tafasitamab; Drug: Lenalidomide

Interventions

Tafasitamab DRUG

The recommended dose of tafasitamab is 12 mg/kg.

Tafasitamab and Lenalidomide Treatment

Lenalidomide DRUG

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

Tafasitamab and Lenalidomide Treatment

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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.

You may not qualify if:

• 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.

Sponsors & Collaborators

• H. Lee Moffitt Cancer Center and Research Institute: lead
• Incyte Corporation: collaborator

Study Sites (1)

Moffitt Cancer Center

Tampa, Florida, 33612, United States

RECRUITING

MeSH Terms

Interventions

tafasitamab; Lenalidomide

Intervention Hierarchy (Ancestors)

Phthalimides; Phthalic Acids; Acids, Carbocyclic; Carboxylic Acids; Organic Chemicals; Piperidones; Piperidines; Heterocyclic Compounds, 1-Ring; Heterocyclic Compounds; Isoindoles; Heterocyclic Compounds, 2-Ring; Heterocyclic Compounds, Fused-Ring

Study Officials

• Frederick Locke, MD

  Moffitt Cancer Center

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Kim Sprenger

CONTACT

813-745-0330; Kimberly.Sprenger@moffitt.org

Study Design

• Study Type: interventional
• Phase: phase 2
• Allocation: NA
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: December 30, 2024
• First Posted: January 6, 2025
• Study Start: March 19, 2025
• Primary Completion (Estimated): January 1, 2027
• Study Completion (Estimated): January 1, 2028
• Last Updated: December 4, 2025

Record last verified: 2025-12

Locations

US (1)