NCT06760156 Tafasitamab and Lenalidomide as First Salvage Therapy for Residual Large B Cell Lym
| NCT ID | NCT06760156 |
| Status | Recruiting |
| Phase | Phase 2 |
| Sponsor | H. Lee Moffitt Cancer Center and Research Institute |
| Condition | Large B-cell Lymphoma |
| Study Type | INTERVENTIONAL |
| Enrollment | 28 participants |
| Start Date | 2025-03-19 |
| Primary Completion | 2027-01 |
Eligibility & Interventions
Eligibility Fast-Check
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What to Expect as a Participant
You will actively receive the study intervention — which may be a drug, biologic, device, or procedure.
In Phase 2, researchers evaluate early signs of effectiveness. You may be randomized to receive the active treatment or a comparator. Monitoring continues closely.
This trial targets 28 participants in total. It began in 2025-03-19 with a primary completion date of 2027-01.
⚠ This information is for research awareness only. Always consult your physician before joining any clinical trial. Participation is voluntary and you may withdraw at any time.
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.
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.
Contact & Investigator
Frederick Locke, MD
PRINCIPAL INVESTIGATOR
Moffitt Cancer Center
Frequently Asked Questions
Who can join the NCT06760156 clinical trial?
This trial is open to participants of all sexes, aged 18 Years or older, studying Large B-cell Lymphoma. Full inclusion and exclusion criteria are listed in the Eligibility Criteria section. Always confirm your eligibility with the research team before applying.
What phase is the NCT06760156 trial and what does that mean for participants?
Phase 2 trials evaluate whether the treatment shows signs of effectiveness while continuing to monitor safety. More participants are enrolled than in Phase 1 to help refine the treatment protocol.
Is NCT06760156 currently recruiting?
Yes, NCT06760156 is actively recruiting participants. Contact the research team at ICETtrials@moffitt.org for enrollment information.
Where is the NCT06760156 trial being conducted?
This trial is being conducted at Tampa, United States.
Who is sponsoring the NCT06760156 clinical trial?
NCT06760156 is sponsored by H. Lee Moffitt Cancer Center and Research Institute. The principal investigator is Frederick Locke, MD at Moffitt Cancer Center. The trial plans to enroll 28 participants.