Ignite Creation Date:
2026-03-26 @ 3:16 PM
Ignite Modification Date:
2026-03-29 @ 11:50 PM
Study NCT ID:
NCT07393204
Status:
ACTIVE_NOT_RECRUITING
Last Update Posted:
2026-02-06
First Post:
2025-12-22
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Italian Real-World Study of Epcoritamab in Relapsed or Refractory DLBCL
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2026-03-25'}, 'conditionBrowseModule': {'meshes': [{'id': 'D016403', 'term': 'Lymphoma, Large B-Cell, Diffuse'}, {'id': 'D012008', 'term': 'Recurrence'}], 'ancestors': [{'id': 'D016393', 'term': 'Lymphoma, B-Cell'}, {'id': 'D008228', 'term': 'Lymphoma, Non-Hodgkin'}, {'id': 'D008223', 'term': 'Lymphoma'}, {'id': 'D009370', 'term': 'Neoplasms by Histologic Type'}, {'id': 'D009369', 'term': 'Neoplasms'}, {'id': 'D008232', 'term': 'Lymphoproliferative Disorders'}, {'id': 'D008206', 'term': 'Lymphatic Diseases'}, {'id': 'D006425', 'term': 'Hemic and Lymphatic Diseases'}, {'id': 'D007160', 'term': 'Immunoproliferative Disorders'}, {'id': 'D007154', 'term': 'Immune System Diseases'}, {'id': 'D020969', 'term': 'Disease Attributes'}, {'id': 'D010335', 'term': 'Pathologic Processes'}, {'id': 'D013568', 'term': 'Pathological Conditions, Signs and Symptoms'}]}}, 'protocolSection': {'designModule': {'studyType': 'OBSERVATIONAL', 'designInfo': {'timePerspective': 'RETROSPECTIVE', 'observationalModel': 'OTHER'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 150}, 'patientRegistry': False}, 'statusModule': {'overallStatus': 'ACTIVE_NOT_RECRUITING', 'startDateStruct': {'date': '2025-12-10', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2026-01', 'completionDateStruct': {'date': '2026-12-10', 'type': 'ESTIMATED'}, 'lastUpdateSubmitDate': '2026-01-30', 'studyFirstSubmitDate': '2025-12-22', 'studyFirstSubmitQcDate': '2026-01-30', 'lastUpdatePostDateStruct': {'date': '2026-02-06', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2026-02-06', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2026-12-10', 'type': 'ESTIMATED'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Overall Response Rate (ORR)', 'timeFrame': 'From date of randomization until the date of first documented progression or date of death from any cause, whichever came first, assessed up to 100 months', 'description': 'Overall Response Rate (ORR), defined as the best objective response achieved during or after treatment with epcoritamab, according to Lugano Criteria'}], 'secondaryOutcomes': [{'measure': 'Adverse Event according to CTCAE v5.0', 'timeFrame': 'through study completion, an average of 1 year', 'description': 'rate and severity of AEs (Adverse Event), AESIs (adverse events of special interest) and SAEs (Serious Adverse Event) according to the Common Terminology Criteria for Adverse Events (CTCAE v.5.0)'}, {'measure': 'Incidence and Severity of Cytokine Release Syndrome (CRS)', 'timeFrame': 'through study completion, an average of 1 year', 'description': 'Incidence and Severity of Cytokine Release Syndrome (CRS) according to ASTCT CRS grading criteria'}, {'measure': 'Incidence and Severity of Immune Effector Cell-Associated Neurotoxicity Syndrome (ICANS)', 'timeFrame': 'through study completion, an average of 1 year', 'description': 'ICANS graded according to ASTCT ICANS grading criteria (ICE score)'}, {'measure': 'Complete Response rate', 'timeFrame': 'through study completion, an average of 1 year', 'description': 'CR rate defined as the proportion of patients with CR, according to Lugano Criteria at 1, 2, 3, 6, 9 and 12 months since treatment start'}, {'measure': 'Duration of Response', 'timeFrame': 'through study completion, an average of 1 year', 'description': 'DoR is defined as the time from the first documentation of response (CR or PR) to the date of PD or death, whichever occurs earlier.'}, {'measure': 'Duration of Complete Response', 'timeFrame': 'through study completion, an average of 1 year', 'description': 'DoCR is defined as the time from the first documentation of CR to the date of PD or death, whichever occurs earlier.'}, {'measure': 'Progression Free Survival', 'timeFrame': 'through study completion, an average of 1 year', 'description': 'PFS is defined as the time from the start of the treatment to first documented PD or death due to any cause, whichever occurs earlier.'}, {'measure': 'Overall Survival', 'timeFrame': 'through study completion, an average of 1 year', 'description': 'OS is defined as the time from the start of epcoritamab treatment to death'}, {'measure': 'Time To Next Treatment', 'timeFrame': 'through study completion, an average of 1 year', 'description': 'TTNT is defined as duration from treatment initiation to the start of new anti-lymphoma therapy or death due to PD, whichever occurs earlier'}, {'measure': 'Duration of Treatment', 'timeFrame': 'through study completion, an average of 1 year', 'description': 'Duration of Treatment (DoT) is defined as the time from the start of the treatment to discontinuation or death due to any cause, whichever occurs earlier.'}, {'measure': 'Health Care Resource Utilization (HCRU)', 'timeFrame': 'through study completion, an average of 1 year', 'description': 'Health Care Resource Utilization (HCRU) as number and duration of unplanned hospitalizations during treatment and follow-up, number of hematological visits, load of diagnostic exams'}]}, 'oversightModule': {'oversightHasDmc': False}, 'conditionsModule': {'keywords': ['DLBCL', 'relapsed', 'refractory'], 'conditions': ['Relapsed Diffuse Large B-cell Lymphoma (DLBCL)', 'Refractory Diffuse Large B-Cell Lymphoma']}, 'descriptionModule': {'briefSummary': 'This study describes the effectiveness of epcoritamab outside the clinical trial setting in pts with DLBCL relapsed or refractory after 2 or more previous lines of therapy'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'minimumAge': '18 Years', 'samplingMethod': 'NON_PROBABILITY_SAMPLE', 'studyPopulation': 'The study is expected to include approximately 150 patients. Patients registered in the Cnn program of epcoritamab (between February 19, 2024 and September 25, 2024) that received at least 1 dose of this antibody.', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* Age ≥ 18 years\n* Patients registered in the Cnn program of epcoritamab (between February 19, 2024 and September 25, 2024)\n* Received at least one dose of epcoritamab\n* Free and voluntary written informed consent\n\nExclusion Criteria:\n\n* Age \\< 18 years\n* Patients who received epcoritamab outside the Cnn program (e.g., open access program, compassionate use, off-label, prospective trials).'}, 'identificationModule': {'nctId': 'NCT07393204', 'acronym': 'EPKEY_HSR', 'briefTitle': 'Italian Real-World Study of Epcoritamab in Relapsed or Refractory DLBCL', 'organization': {'class': 'OTHER', 'fullName': 'IRCCS San Raffaele'}, 'officialTitle': 'Italian Real-world Study on Epcoritamab in Patients With Relapsed or Refractory Diffuse Large B-cell Lymphoma', 'orgStudyIdInfo': {'id': 'EPKEY_HSR'}}, 'armsInterventionsModule': {'armGroups': [{'label': 'Epcoritamab treatment', 'description': 'Patients registered in the Cnn program of epcoritamab (between February 19, 2024 and September 25, 2024) that received at least 1 dose of this antibody.'}]}, 'contactsLocationsModule': {'locations': [{'city': 'Milan', 'country': 'Italy', 'facility': 'IRCCS Ospedale San Raffaele', 'geoPoint': {'lat': 45.46427, 'lon': 9.18951}}]}, 'ipdSharingStatementModule': {'ipdSharing': 'UNDECIDED'}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Andrés José Maria Ferreri', 'class': 'OTHER'}, 'responsibleParty': {'type': 'SPONSOR_INVESTIGATOR', 'investigatorTitle': 'Director of Lymphoma Unit', 'investigatorFullName': 'Andrés José Maria Ferreri', 'investigatorAffiliation': 'IRCCS San Raffaele'}}}}