Ignite Creation Date:
2025-12-25 @ 3:45 AM
Ignite Modification Date:
2025-12-26 @ 2:32 AM
Study NCT ID:
NCT05590702
Status:
ACTIVE_NOT_RECRUITING
Last Update Posted:
2025-12-03
First Post:
2022-10-17
Is NOT Gene Therapy:
False
Has Adverse Events:
False
Brief Title:
French Observational Study of Patients With Chronic Lymphocytic Leukemia Or Small Lymphocytic Lymphoma in Real-World Settings
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}}, 'protocolSection': {'designModule': {'studyType': 'OBSERVATIONAL', 'designInfo': {'timePerspective': 'PROSPECTIVE', 'observationalModel': 'COHORT'}, 'enrollmentInfo': {'type': 'ESTIMATED', 'count': 1000}, 'targetDuration': '7 Years', 'patientRegistry': True}, 'statusModule': {'overallStatus': 'ACTIVE_NOT_RECRUITING', 'startDateStruct': {'date': '2022-11-11', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2025-11', 'completionDateStruct': {'date': '2032-12-01', 'type': 'ESTIMATED'}, 'lastUpdateSubmitDate': '2025-11-25', 'studyFirstSubmitDate': '2022-10-17', 'studyFirstSubmitQcDate': '2022-10-19', 'lastUpdatePostDateStruct': {'date': '2025-12-03', 'type': 'ESTIMATED'}, 'studyFirstPostDateStruct': {'date': '2022-10-21', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2025-04-18', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Representativity of CLL therapies and sequences across', 'timeFrame': '7-year period of time', 'description': 'Number of patients who received a particular type of therapy (chemo-immunotherapy, kinase inhibitors targeting the B-cell receptor signaling, B-cell lymphoma 2 inhibitor) at baseline and in relapse and in which sequence'}], 'secondaryOutcomes': [{'measure': 'Overall survival', 'timeFrame': '7 years', 'description': "registering cause of death focusing on CLL, infection, Richter's syndrome, immune disorders and secondary malignancies"}, {'measure': 'Long-term toxicity', 'timeFrame': '7 years', 'description': 'infection requiring hospitalization, secondary malignancies, cardiac and vascular events'}]}, 'oversightModule': {'isUsExport': False, 'oversightHasDmc': True, 'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'conditions': ['CLL/SLL']}, 'descriptionModule': {'briefSummary': 'Chronic lymphocytic leukemia (CLL) is the most frequent form of leukemia in the Western World. The disease is characterized by the accumulation and proliferation of mature, monoclonal, CD5+ B-cells with specific immunophenotype in the peripheral blood (above 5x109/L), bone marrow and secondary lymphoid organs. Small lymphocytic leukemia (SLL) is characterized by similar tumor cells but without increased lymphocyte count. The management of these patients have considerably changed over the last decade. Indeed, beyond chemo-immunotherapy, multiple targeted therapies have been approved on the basis of phase 2 and randomized phase 3 clinical trials and have subsequently been used in daily practice. The management of patients with SLL is similar to that of those with CLL. In addition to therapeutic advances, the advent of new sequencing technologies has also identified CLL genetic features that are now being incorporated in patient routine evaluation.\n\nWe here propose to set a large-scale prospective and non-interventional study including patients with symptomatic CLL/SLL with the aim to evaluate the real-world clinical management of these patients and to identify the impact of treatments and therapeutic trajectories on long-term outcome.', 'detailedDescription': "Chronic lymphocytic leukemia (CLL) is the most frequent form of leukemia in the Western World. The disease is characterized by the accumulation and proliferation of mature, monoclonal, CD5+ B-cells with specific immunophenotype in the peripheral blood (above 5x109/L), bone marrow and secondary lymphoid organs. Small lymphocytic leukemia (SLL) is characterized by similar tumor cells but without increased lymphocyte count. In Europe, CLL has been identified as the second most frequent hematological malignancies after multiple myeloma (Eurocare 5 study) and its standardized incidence in the world has been estimated to be 4/100000 person-years for men and 2.1/100000 person-years for women. In France, 4674 new cases have been observed in 2018 (FRANCIM). A proportion of patients can initially be monitored only while others with symptomatic disease at diagnosis or during follow-up require therapies. The management of these patients have considerably changed over the last decade. Indeed, beyond chemo-immunotherapy, multiple targeted therapies have been approved on the basis of phase 2 and randomized phase 3 clinical trials and have subsequently been used in daily practice. The management of patients with SLL is similar to that of those with CLL. In addition to therapeutic advances, the advent of new sequencing technologies has also identified CLL genetic features that are now being incorporated in patient routine evaluation.\n\nConventional chemo-immunotherapy (CIT) has been the long-standing option for CLL patient without TP53 disruption and different regimens have emerged depending on patient comorbidities (fludarabine-cyclophosphamide-rituximab, FCR; bendamustin-rituximab, BR; GA101-chloraminophene, G-CLB). These regimens fail to be effective in patients with TP53 disruption and alternative strategies are proposed for them.\n\nThe CLL therapeutic panel is now enriched by oral kinase inhibitors targeting the B-cell receptor signaling. The Bruton's tyrosine kinase inhibitors (BTKi) have been shown to provide prolonged response, even in cases where CIT usually failed, such as patients harboring TP53 disruption. In relapsed/refractory patients, median PFS with the BTKi ibrutinib is 44 months. In the frontline setting, ibrutinib has recently been shown to result in superior PFS and less infectious complications than standard CIT regimens.\n\nThe advent of the BCL2 (B-cell lymphoma 2) inhibitor venetoclax has recently added another option for the treatment of CLL patients. BCL2 is an antiapoptotic molecule governing mitochondrial apoptosis and is strongly expressed in CLL cells. Inhibiting BCL2 with venetoclax as monotherapy led to 79% response rate in the relapse/refractory setting. Combining venetoclax to rituximab demonstrated better PFS than bendamustine-rituximab in relapsed/refractory patients.\n\nHowever, these treatment approaches also come with new challenges that are difficult to-address in phase 3 clinical trials and that deserve larger scale studies and longer follow-up. The emergence of drug resistance, the changes of safety profiles to deal with in routine practice and the observance of these orally administered drugs are emerging as new concerns. How these compounds change the incidence of typical CLL complication such as Richter transformation, immune cytopenias and infections remains to be determined. A growing body of concerns is also raising regarding the unlimited administration of some of this the compounds (costs, resistance, tolerance). Finally, the optimal order of use of these drugs is unknown.\n\nThe advent of the BCL2 (B-cell lymphoma 2) inhibitor venetoclax has recently added another option for the treatment of CLL patients 11,12. BCL2 is an antiapoptotic molecule governing mitochondrial apoptosis and is strongly expressed in CLL cells. Inhibiting BCL2 with venetoclax as monotherapy led to 79% response rate in the relapse/refractory setting. Combining venetoclax to rituximab demonstrated better PFS than bendamustine-rituximab in relapsed/refractory patients12.\n\nHowever, these treatment approaches also come with new challenges that are difficult to-address in phase 3 clinical trials and that deserve larger scale studies and longer follow-up. The emergence of drug resistance, the changes of safety profiles to deal with in routine practice and the observance of these orally administered drugs are emerging as new concerns. How these compounds change the incidence of typical CLL complication such as Richter transformation, immune cytopenias and infections remains to be determined. A growing body of concerns is also raising regarding the unlimited administration of some of this the compounds (costs, resistance, tolerance). Finally, the optimal order of use of these drugs is unknown.\n\nPrimary objective : Setting a prospective cohort of real-world CLL/SLL patients with symptomatic disease in order to evaluate medical practices and their change and representativity over time.\n\nSecondary objectives : Overall survival and long-term toxicity, Response and PFS at each line of therapy, Impact of therapeutic trajectories on patient outcome, Representativity of the studied population"}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'minimumAge': '18 Years', 'samplingMethod': 'NON_PROBABILITY_SAMPLE', 'studyPopulation': 'Patient with CLL or SLL requiring a therapeutic strategy according to iwCLL criteria or investigator evaluation will be identified in MCM (multidisciplinary collegial meeting).', 'healthyVolunteers': False, 'eligibilityCriteria': "Inclusion Criteria:\n\n* Age ≥ 18-year old\n* CLL or SLL requiring a therapeutic strategy according to iwCLL criteria or investigator evaluation\n* Patient requiring therapy for immune events (autoimmune Thrombocytopenia and autoimmune hemolytic anemia) are eligible\n* Patients who have been informed verbally and in writing about this study, and who do not object to their data being electronically processed or subjected to data quality control\n* All consecutive patients for whom a discussion in the setting of local or regional multidisciplinary collegial meeting (in french : réunion de concertation pluridisciplinaire / RCP) has retained the need for starting a therapeutic strategy (curative or palliative)\n* Patients with untreated or previously treated CLL/SLL are both eligible\n* Patients enrolled in a clinical trial can be included in this non-interventional cohort study\n* Patients requiring therapy for CLL/SLL-associated immune events only are also eligible\n\nExclusion Criteria:\n\n* Patients with no need of therapy\n* Patients with asymptomatic Binet A CLL\n* Patient with Richter's syndrome at inclusion\n* Patient requiring immunoglobulin substitution (with no need of a more specific therapy)"}, 'identificationModule': {'nctId': 'NCT05590702', 'acronym': 'FOLLOW', 'briefTitle': 'French Observational Study of Patients With Chronic Lymphocytic Leukemia Or Small Lymphocytic Lymphoma in Real-World Settings', 'organization': {'class': 'OTHER', 'fullName': 'French Innovative Leukemia Organisation'}, 'officialTitle': 'French Observational Study of Patients With Chronic Lymphocytic Leukemia Or Small Lymphocytic Lymphoma in Real-World Settings. A FILO Study.', 'orgStudyIdInfo': {'id': 'FILObsLLC_FOLLOW'}}, 'armsInterventionsModule': {'interventions': [{'name': 'First line therapy', 'type': 'DRUG', 'description': 'Patient with CLL or SLL requiring a therapeutic strategy according to iwCLL criteria or investigator evaluation will be identified in MCM (multidisciplinary collegial meeting).\n\nPatients will be treated and managed according to the decision of their physicians and the related MDM. No treatment plan is recommended in the setting of this non-interventional study.'}]}, 'contactsLocationsModule': {'locations': [{'zip': '80054', 'city': 'Amiens', 'country': 'France', 'facility': 'AMIENS - CH Amiens Picardie Site Sud', 'geoPoint': {'lat': 49.9, 'lon': 2.3}}, {'zip': '49933', 'city': 'Angers', 'country': 'France', 'facility': 'Angers Chu', 'geoPoint': {'lat': 47.47156, 'lon': -0.55202}}, {'zip': '74374', 'city': 'Annecy', 'country': 'France', 'facility': 'ANNECY - CH Annecy Genevois', 'geoPoint': {'lat': 45.90878, 'lon': 6.12565}}, {'city': 'Argenteuil', 'country': 'France', 'facility': 'ARGENTEUIL - Centre hospitalier Victor Dupouy', 'geoPoint': {'lat': 48.94788, 'lon': 2.24744}}, {'zip': '84000', 'city': 'Avignon', 'country': 'France', 'facility': 'AVIGNON - Centre Hospitalier', 'geoPoint': {'lat': 43.94834, 'lon': 4.80892}}, {'zip': '25000', 'city': 'Besançon', 'country': 'France', 'facility': 'BESANCON - Hôpital Jean Minjoz', 'geoPoint': {'lat': 47.24878, 'lon': 6.01815}}, {'zip': '34500', 'city': 'Béziers', 'country': 'France', 'facility': 'BEZIERS - Centre Hospitalier - Hématologie', 'geoPoint': {'lat': 43.34122, 'lon': 3.21402}}, {'zip': '41000', 'city': 'Blois', 'country': 'France', 'facility': 'BLOIS CH', 'geoPoint': {'lat': 47.59432, 'lon': 1.32912}}, {'city': 'Bobigny', 'country': 'France', 'facility': 'APHP - Hôpital Avicenne', 'geoPoint': {'lat': 48.90982, 'lon': 2.45012}}, {'zip': '93140', 'city': 'Bondy', 'country': 'France', 'facility': 'APHP - Hôpital Jean Verdier', 'geoPoint': {'lat': 48.9018, 'lon': 2.48931}}, {'zip': '38300', 'city': 'Bourgoin', 'country': 'France', 'facility': 'BOURGOUIN-JALLIEU - CH Pierre Oudot', 'geoPoint': {'lat': 45.59889, 'lon': 5.27236}}, {'zip': '29609', 'city': 'Brest', 'country': 'France', 'facility': 'BREST - Hôpital Morvan - Hématologie Clinique', 'geoPoint': {'lat': 48.39029, 'lon': -4.48628}}, {'zip': '14033', 'city': 'Caen', 'country': 'France', 'facility': 'CAEN - IHBN - Hématologie Clinique', 'geoPoint': {'lat': 49.18585, 'lon': -0.35912}}, {'city': 'Cergy-Pontoise', 'country': 'France', 'facility': 'CERGY PONTOISE - CH René Dubos', 'geoPoint': {'lat': 49.03894, 'lon': 2.07805}}, {'zip': '73000', 'city': 'Chambéry', 'country': 'France', 'facility': 'CHAMBERY - CH Métropole Savoie', 'geoPoint': {'lat': 45.56628, 'lon': 5.92079}}, {'zip': '63000', 'city': 'Clermont-Ferrand', 'country': 'France', 'facility': 'Clermont-Ferrand - Chu Estaing', 'geoPoint': {'lat': 45.77969, 'lon': 3.08682}}, {'city': 'Corbeil-Essonnes', 'country': 'France', 'facility': 'Corbeil-Essonnes - Chsf', 'geoPoint': {'lat': 48.60603, 'lon': 2.48757}}, {'zip': '21000', 'city': 'Dijon', 'country': 'France', 'facility': 'Dijon Chu', 'geoPoint': {'lat': 47.31344, 'lon': 5.01391}}, {'zip': '38028', 'city': 'Grenoble', 'country': 'France', 'facility': 'GRENOBLE GHM - Institut Daniel Hollard', 'geoPoint': {'lat': 45.17869, 'lon': 5.71479}}, {'zip': '38043', 'city': 'Grenoble', 'country': 'France', 'facility': 'Grenoble - CHUGA - Hématologie Clinique', 'geoPoint': {'lat': 45.17869, 'lon': 5.71479}}, {'zip': '85925', 'city': 'La Roche-sur-Yon', 'country': 'France', 'facility': 'La Roche Sur Yon - Chd Vendee', 'geoPoint': {'lat': 46.66974, 'lon': -1.42757}}, {'city': 'Le Mans', 'country': 'France', 'facility': 'Le Mans CH', 'geoPoint': {'lat': 48.0021, 'lon': 0.20251}}, {'zip': '62300', 'city': 'Lens', 'country': 'France', 'facility': 'LENS - GHT Artois', 'geoPoint': {'lat': 50.43302, 'lon': 2.82791}}, {'zip': '33505', 'city': 'Libourne', 'country': 'France', 'facility': 'LIBOURNE - Hôpital Robert Boulin', 'geoPoint': {'lat': 44.91449, 'lon': -0.24186}}, {'zip': '59000', 'city': 'Lille', 'country': 'France', 'facility': 'LILLE GHICL - Hôpital Saint Vincent de Paul', 'geoPoint': {'lat': 50.63391, 'lon': 3.05512}}, {'zip': '59037', 'city': 'Lille', 'country': 'France', 'facility': 'LILLE CHU - Hôpital Claude Huriez', 'geoPoint': {'lat': 50.63391, 'lon': 3.05512}}, {'zip': '87042', 'city': 'Limoges', 'country': 'France', 'facility': 'LIMOGES - CHU Dupuytren 1', 'geoPoint': {'lat': 45.83362, 'lon': 1.24759}}, {'zip': '69008', 'city': 'Lyon', 'country': 'France', 'facility': 'LYON-Centre Léon Bérard', 'geoPoint': {'lat': 45.74906, 'lon': 4.84789}}, {'city': 'Metz', 'country': 'France', 'facility': 'METZ-THIONVILLE CHR- Hôpital de Mercy', 'geoPoint': {'lat': 49.11911, 'lon': 6.17269}}, {'zip': '34295', 'city': 'Montpellier', 'country': 'France', 'facility': 'MONTPELLIER - Hôpital Saint-Eloi - Hématologie Clinique', 'geoPoint': {'lat': 43.61093, 'lon': 3.87635}}, {'zip': '29672', 'city': 'Morlaix', 'country': 'France', 'facility': 'MORLAIX - CH des pays de Morlaix', 'geoPoint': {'lat': 48.57784, 'lon': -3.82792}}, {'zip': '68100', 'city': 'Mulhouse', 'country': 'France', 'facility': 'Mulhouse - Ghrmsa', 'geoPoint': {'lat': 47.75205, 'lon': 7.32866}}, {'zip': '44093', 'city': 'Nantes', 'country': 'France', 'facility': 'NANTES - Hôpital Hôtel Dieu - Hématologie Clinique', 'geoPoint': {'lat': 47.21725, 'lon': -1.55336}}, {'zip': '30029', 'city': 'Nîmes', 'country': 'France', 'facility': 'NIMES - CHU Caremeau', 'geoPoint': {'lat': 43.83665, 'lon': 4.35788}}, {'zip': '44100', 'city': 'Orléans', 'country': 'France', 'facility': 'ORLEANS - CHR - Hématologie', 'geoPoint': {'lat': 47.90248, 'lon': 1.90407}}, {'zip': '75014', 'city': 'Paris', 'country': 'France', 'facility': 'APHP - HOPITAL COCHIN - Hématologie', 'geoPoint': {'lat': 48.85341, 'lon': 2.3488}}, {'zip': '75651', 'city': 'Paris', 'country': 'France', 'facility': 'APHP - Hôpital Pitié Salpêtrière - Hématologie', 'geoPoint': {'lat': 48.85341, 'lon': 2.3488}}, {'zip': '66000', 'city': 'Perpignan', 'country': 'France', 'facility': 'PERPIGNAN - CH St Jean - Hématologie Clinique', 'geoPoint': {'lat': 42.69764, 'lon': 2.89541}}, {'zip': '33604', 'city': 'Pessac', 'country': 'France', 'facility': 'Bordeaux Pessac', 'geoPoint': {'lat': 44.80565, 'lon': -0.6324}}, {'zip': '24000', 'city': 'Périgueux', 'country': 'France', 'facility': 'Perigueux - Ch', 'geoPoint': {'lat': 45.18691, 'lon': 0.71439}}, {'zip': '69036', 'city': 'Pierre-Bénite', 'country': 'France', 'facility': 'LYON HCL - CH Lyon Sud', 'geoPoint': {'lat': 45.70359, 'lon': 4.82424}}, {'zip': '29000', 'city': 'Quimper', 'country': 'France', 'facility': 'QUIMPER - CH de Cornouaille', 'geoPoint': {'lat': 47.99597, 'lon': -4.09795}}, {'zip': '51092', 'city': 'Reims', 'country': 'France', 'facility': 'Reims Chu', 'geoPoint': {'lat': 49.26526, 'lon': 4.02853}}, {'zip': '35033', 'city': 'Rennes', 'country': 'France', 'facility': 'RENNES - CHU Pontchaillou - Hématologie Clinique', 'geoPoint': {'lat': 48.11109, 'lon': -1.67431}}, {'zip': '35033', 'city': 'Rennes', 'country': 'France', 'facility': 'RENNES - Hôpital Pontchaillou - Hématologie', 'geoPoint': {'lat': 48.11109, 'lon': -1.67431}}, {'zip': '76038', 'city': 'Rouen', 'country': 'France', 'facility': 'ROUEN - Centre Henri Becquerel - Service Hématologie Clinique', 'geoPoint': {'lat': 49.44313, 'lon': 1.09932}}, {'zip': '22027', 'city': 'Saint-Brieuc', 'country': 'France', 'facility': 'SAINT-BRIEUC - Hôpila Yves Le Foll', 'geoPoint': {'lat': 48.51513, 'lon': -2.76838}}, {'city': 'Saint-Pierre', 'country': 'France', 'facility': 'La Reunion - Gh Site Sud', 'geoPoint': {'lat': 43.29282, 'lon': 5.40682}}, {'city': 'Saint-Priest-en-Jarez', 'country': 'France', 'facility': 'ST ETIENNE - CHU et Institut De Cancérologie Lucien Neuwirth', 'geoPoint': {'lat': 45.4739, 'lon': 4.37678}}, {'zip': '67033', 'city': 'Strasbourg', 'country': 'France', 'facility': 'Strasbourg - Icans', 'geoPoint': {'lat': 48.58392, 'lon': 7.74553}}, {'zip': '31059', 'city': 'Toulouse', 'country': 'France', 'facility': "Toulouse - IUCT Oncopole - Service d'Hématologie", 'geoPoint': {'lat': 43.60426, 'lon': 1.44367}}, {'zip': '37000', 'city': 'Tours', 'country': 'France', 'facility': 'TOURS - Hôpital Bretonneau', 'geoPoint': {'lat': 47.39484, 'lon': 0.70398}}, {'city': 'Troyes', 'country': 'France', 'facility': 'Troyes Ch', 'geoPoint': {'lat': 48.30073, 'lon': 4.08524}}, {'zip': '54500', 'city': 'Vandœuvre-lès-Nancy', 'country': 'France', 'facility': 'NANCY - CHU Brabois', 'geoPoint': {'lat': 48.66115, 'lon': 6.17114}}, {'city': 'Vannes', 'country': 'France', 'facility': 'Vannes - Chba', 'geoPoint': {'lat': 47.65688, 'lon': -2.76205}}, {'city': 'Versailles', 'country': 'France', 'facility': 'VERSAILLES - Hôpital André Mignot', 'geoPoint': {'lat': 48.80359, 'lon': 2.13424}}, {'city': 'Villejuif', 'country': 'France', 'facility': 'Villejuif Igr', 'geoPoint': {'lat': 48.7939, 'lon': 2.35992}}], 'overallOfficials': [{'name': 'Romain GUIEZE', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'French Innovative Leukemia Organisation'}, {'name': 'Xavier TROUSSARD', 'role': 'STUDY_CHAIR', 'affiliation': 'French Innovative Leukemia Organisation'}]}, 'ipdSharingStatementModule': {'ipdSharing': 'NO'}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'French Innovative Leukemia Organisation', 'class': 'OTHER'}, 'collaborators': [{'name': 'AbbVie', 'class': 'INDUSTRY'}, {'name': 'AstraZeneca', 'class': 'INDUSTRY'}, {'name': 'BeiGene', 'class': 'INDUSTRY'}, {'name': 'Janssen-Cilag Ltd.', 'class': 'INDUSTRY'}], 'responsibleParty': {'type': 'SPONSOR'}}}}