Large B-cell Lymphoma
Conditions
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.
Interventions
DRUGTafasitamab
The recommended dose of tafasitamab is 12 mg/kg.
DRUGLenalidomide
The starting dose for lenalidomide will be 25 mg PO daily.
Sponsors
H. Lee Moffitt Cancer Center and Research Institute
Incyte Corporation
Study design
Allocation
NA
Intervention model
SINGLE_GROUP
Primary purpose
TREATMENT
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
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.
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Complete Response Rate (CRR) | Up to 3 months | Complete Response Rate (CRR) is defined as the proportion of patients with a Complete Response (CR) |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Objectives Response Rate (ORR) | Up to 12 months | Defined as the incidence of either a complete response (CR) or a partial response (PR) per Lugano Classification as determined by study investigators. |
| Duration of Response (DoR) | Up to 12 months | DoR is defined as the date of their first objective response to disease progression per Lugano Classification as determined by study investigators or death from any cause. |
| Progression Free Survival (PFS) | Up to 12 months | Defined as the time from tafasitamab infusion date to the date of disease progression per Lugano Classification as determined by study investigators or death from any cause. |
Countries
United States
Contacts
CONTACTKim Sprenger
PRINCIPAL_INVESTIGATORFrederick Locke, MD
Moffitt Cancer Center
Outcome results
None listed