Actively Recruiting
Tafasitamab and Lenalidomide as First Salvage Therapy for Residual Large B Cell Lym
Led by H. Lee Moffitt Cancer Center and Research Institute · Updated on 2026-04-03
28
Participants Needed
1
Research Sites
145 weeks
Total Duration
On this page
Sponsors
H
H. Lee Moffitt Cancer Center and Research Institute
Lead Sponsor
I
Incyte Corporation
Collaborating Sponsor
AI-Summary
What this Trial Is 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.
CONDITIONS
Official Title
Tafasitamab and Lenalidomide as First Salvage Therapy for Residual Large B Cell Lym
Who Can Participate
Eligibility Criteria
You may qualify if you...
- Histologically confirmed large B-cell lymphoma, including DLBCL, primary mediastinal large B-cell lymphoma, high grade B-cell lymphoma, or DLBCL arising from follicular lymphoma
- Adults aged 18 years or older at time of informed consent
- Ability to understand and agree to study procedures and sign informed consent
- Measurable PET/CT positive disease (partial response or stable disease) 21 to 60 days after CAR-T with axicabtagene ciloleucel
- Eastern Cooperative Oncology Group (ECOG) performance status 0 to 2
- Adequate organ, bone marrow, hepatic, and renal function
- Baseline oxygen saturation above 92% on room air
- Females of reproductive potential must agree to avoid pregnancy or use two reliable birth control methods starting 4 weeks before lenalidomide and continuing during and 4 weeks after therapy
You will not qualify if you...
- Receipt of any investigational study agent within 4 weeks before screening
- Presence of malignant cells in cerebrospinal fluid, brain metastases, or active central nervous system lymphoma after CAR-T therapy
- History or presence of CNS disorders such as seizure, stroke, dementia, cerebellar disease, or autoimmune CNS disease
- Uncontrolled infections requiring intravenous antimicrobial treatment
- Known cardiac lymphoma involvement
- History of symptomatic pulmonary embolism within 6 months before enrollment
- Known primary immunodeficiency
- History of autoimmune diseases causing organ injury or requiring systemic immunosuppression within 2 years
- History of severe allergic reactions or hypersensitivity to lenalidomide or tafasitamab
- Any medical condition that might interfere with safety or efficacy assessments as determined by the physician
AI-Screening
AI-Powered Screening
Complete this quick 3-step screening to check your eligibility
Trial Site Locations
Total: 1 location
1
Moffitt Cancer Center
Tampa, Florida, United States, 33612
Actively Recruiting
Research Team
K
Kim Sprenger
CONTACT
How is the study designed?
Study Type
INTERVENTIONAL
Masking
NONE
Allocation
NA
Model
SINGLE_GROUP
Primary Purpose
TREATMENT
Number of Arms
1
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