Ignite Creation Date:
2025-12-24 @ 10:50 PM
Ignite Modification Date:
2026-01-02 @ 12:35 AM
Study NCT ID:
NCT06994169
Status:
NOT_YET_RECRUITING
Last Update Posted:
2025-05-29
First Post:
2025-05-20
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Glofitamab in Real Life
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'interventionBrowseModule': {'meshes': [{'id': 'C000720108', 'term': 'glofitamab'}]}}, 'protocolSection': {'designModule': {'studyType': 'OBSERVATIONAL', 'designInfo': {'timePerspective': 'CROSS_SECTIONAL', 'observationalModel': 'COHORT'}, 'enrollmentInfo': {'type': 'ESTIMATED', 'count': 250}, 'targetDuration': '6 Months', 'patientRegistry': True}, 'statusModule': {'overallStatus': 'NOT_YET_RECRUITING', 'startDateStruct': {'date': '2025-08-01', 'type': 'ESTIMATED'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2025-05', 'completionDateStruct': {'date': '2026-11-30', 'type': 'ESTIMATED'}, 'lastUpdateSubmitDate': '2025-05-20', 'studyFirstSubmitDate': '2025-05-20', 'studyFirstSubmitQcDate': '2025-05-20', 'lastUpdatePostDateStruct': {'date': '2025-05-29', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2025-05-29', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2025-11-30', 'type': 'ESTIMATED'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Best Complete Response Rate (best CRR) during treatment, assessed by investigator according to Lugano 2014 criteria.', 'timeFrame': '6 months'}], 'secondaryOutcomes': [{'measure': 'Complete metabolic response rate and overall response rate (ORR) by investigator assessment according to Lugano 2014 criteria', 'timeFrame': '1 month, 2 months, 3 months, 6 months'}, {'measure': 'Progression-free survival (PFS)', 'timeFrame': '6 months'}, {'measure': 'Event-Free Survival (EFS)', 'timeFrame': '6 months'}, {'measure': 'Overall survival (OS)', 'timeFrame': '6 months'}, {'measure': 'immune effector cell-associated neurotoxicity syndrome (ICANS) rate', 'timeFrame': '6 months'}, {'measure': '≥ grade 2 Cytokine release syndrome (CRS) rate', 'timeFrame': '6 months'}, {'measure': 'intensive care unit (ICU) admission rate', 'timeFrame': '6 months'}, {'measure': 'rate and cause of rehospitalization due to an adverse event potentially related to Glofitamab,', 'timeFrame': '6 months'}, {'measure': 'number of significant medical events leading to hospitalization', 'timeFrame': '6 months'}]}, 'oversightModule': {'oversightHasDmc': False, 'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'keywords': ['CAR-T', 'Glofitamab'], 'conditions': ['Large B-cell Lymphoma']}, 'descriptionModule': {'briefSummary': 'To date, more than 300 patients have been treated with Glofitamab in the Expanded Access Programme (EAP) in France. In this study, it is proposed to perform a retrospective analysis of some of these patients. The aim is to describe the efficacy and safety of Glofitamab in the largest reported real-world cohort, with an expected median follow-up of more than 9 months. Particular focus will be given to the relapsed or refractory chimeric antigen receptors-T (CAR-T) population to confirm the response rates (CRR: 35-39%) of Glofitamab in this population and to assess the optimal timing of therapy initiation \\[8, 15\\].'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'minimumAge': '18 Years', 'samplingMethod': 'NON_PROBABILITY_SAMPLE', 'studyPopulation': 'French patients enrolled in the EAP before 1st of November 2024 and treated with at least Obinutuzumab pretreatment and one infusion of Glofitamab for R/R DLBCL We expect to collect data from 200-250 patients from this population with a minimum of 6 months of follow-up.', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* patient enrolled in the French Glofitamab EAP for R/R DLBCL before 2024 November 1st, 2024\n* patient who received at least Obinutuzumab pretreatment and one infusion of Glofitamab\n* adult patient\n* patient who is informed of the study and who did not oppose to their data collection\n\nExclusion Criteria:\n\n* none'}, 'identificationModule': {'nctId': 'NCT06994169', 'briefTitle': 'Glofitamab in Real Life', 'organization': {'class': 'OTHER', 'fullName': 'The Lymphoma Academic Research Organisation'}, 'officialTitle': 'Glofitamab in Real Life', 'orgStudyIdInfo': {'id': 'GloRel'}}, 'armsInterventionsModule': {'armGroups': [{'label': 'Patients treated in EPA', 'description': 'Patients treated in Expanded Access Program to Glofitamab', 'interventionNames': ['Drug: Glofitamab']}], 'interventions': [{'name': 'Glofitamab', 'type': 'DRUG', 'description': 'Glofitamab received for DLBCL in Early Phase Access', 'armGroupLabels': ['Patients treated in EPA']}]}, 'contactsLocationsModule': {'locations': [{'zip': '95100', 'city': 'Argenteuil', 'country': 'France', 'contacts': [{'name': 'Driss CHAOUI, MD', 'role': 'CONTACT'}], 'facility': 'CH Victor Dupouy', 'geoPoint': {'lat': 48.94788, 'lon': 2.24744}}, {'zip': '84000', 'city': 'Avignon', 'country': 'France', 'contacts': [{'name': 'Hacene ZERAZHI, MD', 'role': 'CONTACT'}], 'facility': "CH d'Avignon - Hôpital Henri Dufaut", 'geoPoint': {'lat': 43.94834, 'lon': 4.80892}}, {'city': 'Bayonne', 'country': 'France', 'contacts': [{'name': 'Sophie BERNARD, MD', 'role': 'CONTACT'}], 'facility': 'CH de la Côte Basque', 'geoPoint': {'lat': 43.49316, 'lon': -1.473}}, {'city': 'Besançon', 'country': 'France', 'contacts': [{'name': 'Adrien CHAUCHET, MD', 'role': 'CONTACT'}], 'facility': 'CHRU Besançon - Hôpital Minjoz', 'geoPoint': {'lat': 47.24878, 'lon': 6.01815}}, {'zip': '92141', 'city': 'Clamart', 'country': 'France', 'contacts': [{'name': 'Xavier PHINA-ZIEBIN', 'role': 'CONTACT'}], 'facility': "Hopital D'Instruction Des Armees Percy", 'geoPoint': {'lat': 48.80299, 'lon': 2.26692}}, {'city': 'Créteil', 'country': 'France', 'contacts': [{'name': 'François LEMONNIER, MD', 'role': 'CONTACT'}], 'facility': 'Hopital Henri Mondor', 'geoPoint': {'lat': 48.79266, 'lon': 2.46569}}, {'zip': '21000', 'city': 'Dijon', 'country': 'France', 'contacts': [{'name': 'Cédric ROSSI, MD', 'role': 'CONTACT'}], 'facility': 'CHU de Dijon - Hôpital le Bocage', 'geoPoint': {'lat': 47.31344, 'lon': 5.01391}}, {'city': 'Dunkirk', 'country': 'France', 'contacts': [{'name': 'Christophe FRUCHART, MD', 'role': 'CONTACT'}], 'facility': 'CH de Dunkerque', 'geoPoint': {'lat': 51.0344, 'lon': 2.37681}}, {'city': 'La Tronche', 'country': 'France', 'contacts': [{'name': 'Sylvain CARRAS, MD', 'role': 'CONTACT'}], 'facility': 'CHU de Grenoble - Hôpital Albert Michallon', 'geoPoint': {'lat': 45.20507, 'lon': 5.74629}}, {'city': 'Libourne', 'country': 'France', 'contacts': [{'name': 'Gaelle LABOURE, MD', 'role': 'CONTACT'}], 'facility': 'Hôpital de Libourne', 'geoPoint': {'lat': 44.91449, 'lon': -0.24186}}, {'city': 'Lille', 'country': 'France', 'contacts': [{'name': 'Franck MORSHHAUSER, MD', 'role': 'CONTACT'}], 'facility': 'CHRU de LILLE - Claude Huriez', 'geoPoint': {'lat': 50.63391, 'lon': 3.05512}}, {'city': 'Lille', 'country': 'France', 'contacts': [{'name': 'Sandy AMORIM, MD', 'role': 'CONTACT'}], 'facility': 'Hopital Saint Vincent-de-Paul', 'geoPoint': {'lat': 50.63391, 'lon': 3.05512}}, {'zip': '69373', 'city': 'Lyon', 'country': 'France', 'contacts': [{'name': 'Laure LEBRAS, MD', 'role': 'CONTACT'}], 'facility': 'Centre Léon Bérard', 'geoPoint': {'lat': 45.74906, 'lon': 4.84789}}, {'city': 'Marseille', 'country': 'France', 'contacts': [{'name': 'Gabriel BRISOU, MD', 'role': 'CONTACT'}], 'facility': 'INSTITUT PAOLI CALMETTES - Service Hématologie', 'geoPoint': {'lat': 43.29695, 'lon': 5.38107}}, {'city': 'Montauban', 'country': 'France', 'contacts': [{'name': 'Reda TABRIZI, MD', 'role': 'CONTACT'}], 'facility': 'Clinique du Pont de Chaume', 'geoPoint': {'lat': 44.01759, 'lon': 1.3542}}, {'zip': '68070', 'city': 'Mulhouse', 'country': 'France', 'contacts': [{'name': 'Bernard DRENOU, MD', 'role': 'CONTACT'}], 'facility': 'CH de Mulhouse Sud Alsace', 'geoPoint': {'lat': 47.75205, 'lon': 7.32866}}, {'city': 'Orléans', 'country': 'France', 'contacts': [{'name': 'Marlène OCHMANN, MD', 'role': 'CONTACT'}], 'facility': "CHR d'Orléans", 'geoPoint': {'lat': 47.90248, 'lon': 1.90407}}, {'city': 'Paris', 'country': 'France', 'contacts': [{'name': 'Catherine THIEBLEMONT, MD', 'role': 'CONTACT'}], 'facility': 'Hopital Saint-Louis', 'geoPoint': {'lat': 48.85341, 'lon': 2.3488}}, {'city': 'Pessac', 'country': 'France', 'contacts': [{'name': 'François-Xavier GROS, MD', 'role': 'CONTACT'}], 'facility': 'Chu de Bordeaux - Hopital Haut-Leveque', 'geoPoint': {'lat': 44.80565, 'lon': -0.6324}}, {'city': 'Pierre-Bénite', 'country': 'France', 'contacts': [{'name': 'Hervé GHESQUIERES, MD', 'role': 'CONTACT'}], 'facility': 'CHU Lyon Sud', 'geoPoint': {'lat': 45.70359, 'lon': 4.82424}}, {'city': 'Poitiers', 'country': 'France', 'contacts': [{'name': 'Stéphanie GUIDEZ, MD', 'role': 'CONTACT'}], 'facility': 'CHU de Poitiers - Hôpital de La Milétrie', 'geoPoint': {'lat': 46.58261, 'lon': 0.34348}}, {'zip': '29107', 'city': 'Quimper', 'country': 'France', 'contacts': [{'name': 'Ronan LE CALLOCH, MD', 'role': 'CONTACT'}], 'facility': 'CH de Quimper Cornouaille', 'geoPoint': {'lat': 47.99597, 'lon': -4.09795}}, {'city': 'Rennes', 'country': 'France', 'contacts': [{'name': 'Roch HOUOT, MD', 'role': 'CONTACT'}], 'facility': 'CHU de Rennes - Hôpital de Pontchaillou', 'geoPoint': {'lat': 48.11109, 'lon': -1.67431}}, {'city': 'Saint-Cloud', 'country': 'France', 'contacts': [{'name': 'Clémentine SARKOZY, MD', 'role': 'CONTACT'}], 'facility': 'Institut Curie - Site Saint-Cloud', 'geoPoint': {'lat': 48.84598, 'lon': 2.20289}}, {'city': 'Strasbourg', 'country': 'France', 'contacts': [{'name': 'Luc-Mathieu FORNECKER, MD', 'role': 'CONTACT'}], 'facility': 'CHU de Strasbourg', 'geoPoint': {'lat': 48.58392, 'lon': 7.74553}}, {'city': 'Toulouse', 'country': 'France', 'contacts': [{'name': 'Loïc YSEBAERT, MD', 'role': 'CONTACT'}], 'facility': 'Institut Universitaire du Cancer de Toulouse - Oncopole', 'geoPoint': {'lat': 43.60426, 'lon': 1.44367}}, {'city': 'Tours', 'country': 'France', 'contacts': [{'name': 'Laurianne DRIEU LA ROCHELLE, MD', 'role': 'CONTACT'}], 'facility': 'Chu Bretonneau', 'geoPoint': {'lat': 47.39484, 'lon': 0.70398}}, {'city': 'Vandœuvre-lès-Nancy', 'country': 'France', 'contacts': [{'name': 'Pierre FEUGIER, MD', 'role': 'CONTACT'}], 'facility': 'CHRU de Nancy - Hôpital de Brabois', 'geoPoint': {'lat': 48.66115, 'lon': 6.17114}}, {'city': 'Vannes', 'country': 'France', 'contacts': [{'name': 'Antoine BONNET, MD', 'role': 'CONTACT'}], 'facility': 'Ch de Bretagne Atlantique', 'geoPoint': {'lat': 47.65688, 'lon': -2.76205}}, {'city': 'Villejuif', 'country': 'France', 'contacts': [{'name': 'Vincent RIBRAG, MD', 'role': 'CONTACT'}], 'facility': 'Gustave Roussy Cancer Campus Grand Paris', 'geoPoint': {'lat': 48.7939, 'lon': 2.35992}}], 'centralContacts': [{'name': 'PROJECT MANAGER', 'role': 'CONTACT', 'email': 'glorel@lysarc.org', 'phone': '+33 4 72 66 93 33'}], 'overallOfficials': [{'name': 'Guillaume MANSON, MD', 'role': 'STUDY_CHAIR', 'affiliation': 'Lymphoma Study Association'}, {'name': 'Gilles CROCHET, MD', 'role': 'STUDY_CHAIR', 'affiliation': 'The Lymphoma Academic Research Organisation'}]}, 'ipdSharingStatementModule': {'ipdSharing': 'NO'}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'The Lymphoma Academic Research Organisation', 'class': 'OTHER'}, 'responsibleParty': {'type': 'SPONSOR'}}}}