Ignite Creation Date:
2025-12-25 @ 12:12 AM
Ignite Modification Date:
2025-12-25 @ 10:14 PM
Study NCT ID:
NCT05927558
Status:
RECRUITING
Last Update Posted:
2023-12-29
First Post:
2023-06-22
Is NOT Gene Therapy:
False
Has Adverse Events:
False
Brief Title:
Salvage Treatment With Glofitamab in R/R B-NHL: a GIMEMA-FIL Study
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D016393', 'term': 'Lymphoma, B-Cell'}, {'id': 'D012008', 'term': 'Recurrence'}, {'id': 'D008223', 'term': 'Lymphoma'}], 'ancestors': [{'id': 'D008228', 'term': 'Lymphoma, Non-Hodgkin'}, {'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': 'CASE_ONLY'}, 'enrollmentInfo': {'type': 'ESTIMATED', 'count': 96}, 'patientRegistry': False}, 'statusModule': {'overallStatus': 'RECRUITING', 'startDateStruct': {'date': '2023-12-22', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2023-12', 'completionDateStruct': {'date': '2025-12', 'type': 'ESTIMATED'}, 'lastUpdateSubmitDate': '2023-12-22', 'studyFirstSubmitDate': '2023-06-22', 'studyFirstSubmitQcDate': '2023-06-22', 'lastUpdatePostDateStruct': {'date': '2023-12-29', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2023-07-03', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2025-12', 'type': 'ESTIMATED'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Rate of patients in complete response', 'timeFrame': '6 months', 'description': 'Effectiveness of glofitamab in terms of complete response'}]}, 'oversightModule': {'oversightHasDmc': False, 'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'conditions': ['B-cell Non Hodgkin Lymphoma', 'Relapse', 'Refractory Lymphoma']}, 'descriptionModule': {'briefSummary': 'The goal of this observational study is to evaluate the anti-lymphoma activity of glofitamab, administered according to the Compassionate Use Program, in relapsed/refractory B-NHL patients. The main question it aims to answer is the rate of patients in complete response.', 'detailedDescription': 'This is an observational multicenter study aimed at assessing the anti-lymphoma activity of glofitamab in relapsed/refractory B cell non-Hodgikin lymphoma patients treated according to the Compassionate Use Program in Italy between March 2022 and September 2023. Patients will be observed for a minimum of 12 months after the last glofitamab administration.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'minimumAge': '18 Years', 'samplingMethod': 'NON_PROBABILITY_SAMPLE', 'studyPopulation': 'Adult patients with refractory/relapsed B-cell non-Hodgkin lymphoma treated in Italy according to the Compassionate Use Program between March 2022 and September 2023', 'eligibilityCriteria': 'Inclusion Criteria:\n\n1. Patients who received glofitamab according to Compassionate Use Program AG42296\n2. Age \\> 18 years\n3. Patients who received at least one dose of glofitamab between March 2022 and September 2023 in the context of the compassionate use program and who completed at least 1 year of observation after last glofitamab administration unless the patient died or was lost to follow up\n4. Patients who provided their consent according to local regulation to collect their data for study purposes, dead patients or patients lost to follow up for which any attempt has been made to collect their consent, according to local regulation on data privacy\n\nExclusion Criteria:\n\n* None'}, 'identificationModule': {'nctId': 'NCT05927558', 'briefTitle': 'Salvage Treatment With Glofitamab in R/R B-NHL: a GIMEMA-FIL Study', 'organization': {'class': 'OTHER', 'fullName': "Gruppo Italiano Malattie EMatologiche dell'Adulto"}, 'officialTitle': 'Salvage Treatment With Glofitamab in Patients Affected by Relapsed/Refractory Non-Hodgkin B-cell Lymphoma: a GIMEMA-FIL Study', 'orgStudyIdInfo': {'id': 'IMM0123'}}, 'contactsLocationsModule': {'locations': [{'city': 'Milan', 'status': 'RECRUITING', 'country': 'Italy', 'contacts': [{'name': 'Paolo Corradini', 'role': 'CONTACT'}], 'facility': 'Ematologia Istituto Nazionale Tumori', 'geoPoint': {'lat': 42.78235, 'lon': 12.59836}}], 'centralContacts': [{'name': 'Paola Fazi', 'role': 'CONTACT', 'email': 'p.fazi@gimema.it', 'phone': '0670390528'}, {'name': 'Enrico Crea', 'role': 'CONTACT', 'email': 'e.crea@gimema.it', 'phone': '0670390514'}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': "Gruppo Italiano Malattie EMatologiche dell'Adulto", 'class': 'OTHER'}, 'responsibleParty': {'type': 'SPONSOR'}}}}