RECRUITING

Phase 2 Study of Tafasitamab and Lenalidomide as First Salvage Therapy for Residual Large B Cell Lym

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Study Overview

This clinical trial focuses on testing the efficacy of different digital interventions to promote re-engagement in cancer-related long-term follow-up care for adolescent and young adult (AYA) survivors of childhood cancer.

Description

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.

Official Title

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

Quick Facts

Study Start:2025-01

Study Completion:2028-01

Study Type:Not specified

Phase:Not Applicable

Enrollment:Not specified

Status:RECRUITING

Study ID

NCT06760156

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Ages Eligible for Study:18 Years

Sexes Eligible for Study:ALL

Accepts Healthy Volunteers:No

Standard Ages:ADULT, OLDER_ADULT

Inclusion Criteria	Exclusion 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.	* 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.

Inclusion Criteria

Exclusion 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.

* 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.

Contacts and Locations

Study Contact

Kim Sprenger

CONTACT

813-745-0330

Kimberly.Sprenger@moffitt.org

Principal Investigator

Frederick Locke, MD

PRINCIPAL_INVESTIGATOR

Moffitt Cancer Center

Study Locations (Sites)

Moffitt Cancer Center

Tampa, Florida, 33612

United States

Collaborators and Investigators

Sponsor: H. Lee Moffitt Cancer Center and Research Institute

Frederick Locke, MD, PRINCIPAL_INVESTIGATOR, Moffitt Cancer Center

Study Record Dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Registration Dates

Study Start Date2025-01

Study Completion Date2028-01

Study Record Updates

Study Start Date2025-01

Study Completion Date2028-01

Terms related to this study

Additional Relevant MeSH Terms

Large B-cell Lymphoma