Phase 2 Study of Tafasitamab and Lenalidomide as First Salvage Therapy for Residual Large B Cell Lymphoma After Axicabtagene Ciloleucel

Status: Recruiting
Location: See location...
Intervention Type: Drug
Study Type: Interventional
Study Phase: Phase 2
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
Participation Requirements
Sex: All
Minimum Age: 18
Healthy Volunteers: f
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• 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.

Locations
United States
Florida
Moffitt Cancer Center
RECRUITING
Tampa
Contact Information
Primary
Kim Sprenger
Kimberly.Sprenger@moffitt.org
813-745-0330
Time Frame
Start Date: 2025-03-19
Estimated Completion Date: 2028-01
Participants
Target number of participants: 28
Treatments
Experimental: 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.
Related Therapeutic Areas
Sponsors
Collaborators: Incyte Corporation
Leads: H. Lee Moffitt Cancer Center and Research Institute

This content was sourced from clinicaltrials.gov