Ignite Creation Date:
2025-12-24 @ 11:20 PM
Ignite Modification Date:
2026-02-20 @ 4:47 PM
Study NCT ID:
NCT06760156
Status:
RECRUITING
Last Update Posted:
2025-12-04
First Post:
2024-12-30
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Tafasitamab and Lenalidomide as First Salvage Therapy for Residual Large B Cell Lym
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'interventionBrowseModule': {'meshes': [{'id': 'C000613469', 'term': 'tafasitamab'}, {'id': 'D000077269', 'term': 'Lenalidomide'}], 'ancestors': [{'id': 'D010797', 'term': 'Phthalimides'}, {'id': 'D010795', 'term': 'Phthalic Acids'}, {'id': 'D000146', 'term': 'Acids, Carbocyclic'}, {'id': 'D002264', 'term': 'Carboxylic Acids'}, {'id': 'D009930', 'term': 'Organic Chemicals'}, {'id': 'D010881', 'term': 'Piperidones'}, {'id': 'D010880', 'term': 'Piperidines'}, {'id': 'D006573', 'term': 'Heterocyclic Compounds, 1-Ring'}, {'id': 'D006571', 'term': 'Heterocyclic Compounds'}, {'id': 'D054833', 'term': 'Isoindoles'}, {'id': 'D006574', 'term': 'Heterocyclic Compounds, 2-Ring'}, {'id': 'D000072471', 'term': 'Heterocyclic Compounds, Fused-Ring'}]}}, 'protocolSection': {'designModule': {'phases': ['PHASE2'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'NA', 'maskingInfo': {'masking': 'NONE'}, 'primaryPurpose': 'TREATMENT', 'interventionModel': 'SINGLE_GROUP'}, 'enrollmentInfo': {'type': 'ESTIMATED', 'count': 28}}, 'statusModule': {'overallStatus': 'RECRUITING', 'startDateStruct': {'date': '2025-03-19', 'type': 'ACTUAL'}, 'statusVerifiedDate': '2025-12', 'completionDateStruct': {'date': '2028-01', 'type': 'ESTIMATED'}, 'lastUpdateSubmitDate': '2025-12-02', 'studyFirstSubmitDate': '2024-12-30', 'studyFirstSubmitQcDate': '2024-12-30', 'lastUpdatePostDateStruct': {'date': '2025-12-04', 'type': 'ESTIMATED'}, 'studyFirstPostDateStruct': {'date': '2025-01-06', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2027-01', 'type': 'ESTIMATED'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Complete Response Rate (CRR)', 'timeFrame': 'Up to 3 months', 'description': 'Complete Response Rate (CRR) is defined as the proportion of patients with a Complete Response (CR)'}], 'secondaryOutcomes': [{'measure': 'Objectives Response Rate (ORR)', 'timeFrame': 'Up to 12 months', 'description': 'Defined as the incidence of either a complete response (CR) or a partial response (PR) per Lugano Classification as determined by study investigators.'}, {'measure': 'Duration of Response (DoR)', 'timeFrame': 'Up to 12 months', 'description': '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.'}, {'measure': 'Progression Free Survival (PFS)', 'timeFrame': 'Up to 12 months', 'description': '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.'}]}, 'oversightModule': {'oversightHasDmc': True, 'isFdaRegulatedDrug': True, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'conditions': ['Large B-cell Lymphoma']}, 'descriptionModule': {'briefSummary': '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.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'minimumAge': '18 Years', 'healthyVolunteers': False, 'eligibilityCriteria': "Inclusion Criteria:\n\n* 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.\n* Adult males or females must be of age ≥18 years or older at time of signing informed consent.\n* Patients must be capable of understanding the protocol with willingness to comply with all study procedures including availability for the duration of the study.\n* Patients must be able to understand and willing to sign a written informed consent form (ICF) document.\n* 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.\n* Eastern Cooperative Oncology Group (ECOG) performance status 0-2.\n* Participants must have adequate organ and bone marrow function.\n* Patients must have adequate hepatic function.\n* Patients must have adequate renal function.\n* Baseline Oxygen Saturation \\>92% on room air.\n* 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.\n\nExclusion Criteria:\n\n* Patients who are currently receiving or who have received any investigational study agent ≤4 weeks prior to the screening visit are ineligible.\n* Detectable cerebrospinal fluid malignant cells, brain metastases, or active central nervous system (CNS) lymphoma after CAR T cell administration.\n* History or presence of CNS disorder, such as seizure disorder, cerebrovascular ischemia/hemorrhage, dementia, cerebellar disease, or any autoimmune disease with CNS involvement.\n* Presence of bacterial, viral, fungal, and/or other infection of any origin that is uncontrolled and/or requires intravenous (IV) antimicrobials for treatment.\n* Known cardiac atrial or cardiac ventricular lymphoma involvement.\n* History of symptomatic pulmonary embolism within 6 months of enrollment.\n* Known primary immunodeficiency.\n* 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.\n* History of hypersensitivity, allergy or severe skin reactions to lenalidomide (e.g., angioedema, Stevens-Johnson syndrome, toxic epidermal necrolysis).\n* History of hypersensitivity, allergy or previous exposure to tafasitamab.\n* Any medical condition deemed by the treating physician likely to interfere with assessment of safety or efficacy of study treatment."}, 'identificationModule': {'nctId': 'NCT06760156', 'briefTitle': 'Tafasitamab and Lenalidomide as First Salvage Therapy for Residual Large B Cell Lym', 'organization': {'class': 'OTHER', 'fullName': 'H. Lee Moffitt Cancer Center and Research Institute'}, 'officialTitle': 'Phase 2 Study of Tafasitamab and Lenalidomide as First Salvage Therapy for Residual Large B Cell Lymphoma After Axicabtagene Ciloleucel', 'orgStudyIdInfo': {'id': 'MCC-21955'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'EXPERIMENTAL', 'label': 'Tafasitamab and Lenalidomide Treatment', 'description': '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.', 'interventionNames': ['Drug: Tafasitamab', 'Drug: Lenalidomide']}], 'interventions': [{'name': 'Tafasitamab', 'type': 'DRUG', 'description': 'The recommended dose of tafasitamab is 12 mg/kg.', 'armGroupLabels': ['Tafasitamab and Lenalidomide Treatment']}, {'name': 'Lenalidomide', 'type': 'DRUG', 'description': 'The starting dose for lenalidomide will be 25 mg PO daily.', 'armGroupLabels': ['Tafasitamab and Lenalidomide Treatment']}]}, 'contactsLocationsModule': {'locations': [{'zip': '33612', 'city': 'Tampa', 'state': 'Florida', 'status': 'RECRUITING', 'country': 'United States', 'contacts': [{'name': 'Frederick Locke, MD', 'role': 'PRINCIPAL_INVESTIGATOR'}, {'name': 'Julio Chavez, MD', 'role': 'SUB_INVESTIGATOR'}, {'name': 'Sameh Gaballa, MD', 'role': 'SUB_INVESTIGATOR'}, {'name': 'Michael Jain, MD, PhD', 'role': 'SUB_INVESTIGATOR'}, {'name': 'Farhad Khimani, MD', 'role': 'SUB_INVESTIGATOR'}, {'name': 'Aleksandr Lazaryan, MD, PhD', 'role': 'SUB_INVESTIGATOR'}, {'name': 'Sayeef Mirza, MD', 'role': 'SUB_INVESTIGATOR'}, {'name': 'Taiga Nishihori, MD', 'role': 'SUB_INVESTIGATOR'}, {'name': 'Bijal Shah, MD', 'role': 'SUB_INVESTIGATOR'}], 'facility': 'Moffitt Cancer Center', 'geoPoint': {'lat': 27.94752, 'lon': -82.45843}}], 'centralContacts': [{'name': 'Kim Sprenger', 'role': 'CONTACT', 'email': 'Kimberly.Sprenger@moffitt.org', 'phone': '813-745-0330'}], 'overallOfficials': [{'name': 'Frederick Locke, MD', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'Moffitt Cancer Center'}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'H. Lee Moffitt Cancer Center and Research Institute', 'class': 'OTHER'}, 'collaborators': [{'name': 'Incyte Corporation', 'class': 'INDUSTRY'}], 'responsibleParty': {'type': 'SPONSOR'}}}}