Tafasitamab and Lenalidomide as First Salvage Therapy for Residual Large B Cell Lym
Purpose
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.
Condition
- Large B-cell Lymphoma
Eligibility
- Eligible Ages
- Over 18 Years
- Eligible Sex
- All
- Accepts Healthy Volunteers
- No
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.
Study Design
- Phase
- Phase 2
- Study Type
- Interventional
- Allocation
- N/A
- Intervention Model
- Single Group Assignment
- Primary Purpose
- Treatment
- Masking
- None (Open Label)
Arm Groups
| Arm | Description | Assigned Intervention |
|---|---|---|
|
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. |
|
Recruiting Locations
Moffitt Cancer Center
Tampa 4174757, Florida 4155751 33612
Tampa 4174757, Florida 4155751 33612
More Details
- Status
- Recruiting
- Sponsor
- H. Lee Moffitt Cancer Center and Research Institute